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Study of Chokeberry to Reduce Cardiovascular Disease Risk in Former Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01541826
Recruitment Status : Completed
First Posted : March 1, 2012
Results First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Bradley Bolling, University of Connecticut

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Basic Science
Conditions Cardiovascular Disease
Oxidative Stress
Interventions Dietary Supplement: Chokeberry Extract
Dietary Supplement: Placebo capsule
Dietary Supplement: Chokeberry extract capsule, acute
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule Chaokeberry Extract Capsule (Acute)
Hide Arm/Group Description

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry extract capsule

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.

Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.

Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
Period Title: Overall Study
Started 28 28 6
Completed 24 25 6
Not Completed 4 3 0
Reason Not Completed
Lost to Follow-up             2             3             0
Withdrawal by Subject             2             0             0
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule Chokeberry Extract Capsule (Acute) Total
Hide Arm/Group Description

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry extract capsule

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.

Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose. Total of all reporting groups
Overall Number of Baseline Participants 24 25 6 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 25 participants 6 participants 55 participants
37.4  (14.8) 32.6  (12.7) 31.3  (12.8) 34.9  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 25 participants 6 participants 55 participants
Female
13
  54.2%
12
  48.0%
3
  50.0%
28
  50.9%
Male
11
  45.8%
13
  52.0%
3
  50.0%
27
  49.1%
Height  
Mean (Standard Deviation)
Unit of measure:  m
Number Analyzed 24 participants 25 participants 6 participants 55 participants
1.73  (0.92) 1.71  (0.83) 1.74  (0.97) 1.72  (0.87)
Average years of smoking   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 25 participants 5 participants 54 participants
14.9  (11.9) 8.96  (6.68) 4.8  (3.0) 11.9  (10.0)
[1]
Measure Analysis Population Description: Missing value for one participant in acute study.
Degree of past smoking   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
3-5 cigarettes/day Number Analyzed 24 participants 25 participants 5 participants 54 participants
2
   8.3%
4
  16.0%
1
  20.0%
7
  13.0%
6-10 cigarettes/day Number Analyzed 24 participants 25 participants 5 participants 54 participants
4
  16.7%
7
  28.0%
1
  20.0%
12
  22.2%
11-15 cigarettes/day Number Analyzed 24 participants 25 participants 5 participants 54 participants
4
  16.7%
4
  16.0%
2
  40.0%
10
  18.5%
16-20 cigarettes/day Number Analyzed 24 participants 25 participants 5 participants 54 participants
11
  45.8%
6
  24.0%
0
   0.0%
17
  31.5%
>20 cigarettes/day Number Analyzed 24 participants 25 participants 5 participants 54 participants
3
  12.5%
4
  16.0%
1
  20.0%
8
  14.8%
[1]
Measure Analysis Population Description: Missing value for one participant in acute study.
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 24 participants 25 participants 6 participants 55 participants
81.5  (17.2) 77.2  (21.1) 72.8  (9.5) 79.3  (19.2)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 24 participants 25 participants 6 participants 55 participants
27.2  (4.7) 25.7  (5.0) 24.1  (2.3) 26.5  (4.9)
Waist circumference  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 24 participants 25 participants 6 participants 55 participants
86.0  (17.1) 90.9  (35.1) 79.4  (8.4) 88.5  (27.6)
Systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 24 participants 25 participants 6 participants 55 participants
121  (14) 117  (16) 111.3  (7.7) 119  (15)
Diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 24 participants 25 participants 6 participants 55 participants
76.0  (10.4) 75.3  (12.0) 73.3  (4.7) 75.6  (11.0)
Total cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 24 participants 25 participants 6 participants 55 participants
203  (36) 220  (63) 160  (30) 213  (51)
HDL-cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 24 participants 25 participants 6 participants 55 participants
28.7  (6.1) 26.8  (7.6) 54.8  (15.7) 27.6  (6.9)
LDL-cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 24 participants 25 participants 6 participants 55 participants
158  (30) 175  (54) 99.2  (19.2) 168  (44)
Triglycerides  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 24 participants 25 participants 6 participants 55 participants
82.1  (37.3) 89.6  (45.4) 69.2  (27.1) 86.3  (41.0)
Total cholesterol/HDL cholesterol  
Mean (Standard Deviation)
Unit of measure:  Dimensionless ratio
Number Analyzed 24 participants 25 participants 6 participants 55 participants
7.3  (1.5) 8.5  (2.7) 3.2  (0.7) 8.0  (2.3)
1.Primary Outcome
Title LDL Cholesterol
Hide Description Change in LDL cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 6 weeks, 12 weeks of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: mg/dL
6 weeks 0.9  (4.2) -12.6  (5.3)
12 weeks -0.4  (5.9) -18.5  (7.8)
2.Secondary Outcome
Title Total Cholesterol
Hide Description Change in fasting total cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame 6 and 12 weeks after supplementation
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: mg/dL
Baseline 203  (7) 220  (13)
6 weeks (change from baseline) -0.1  (4.6) 1.4  (2.5)
12 weeks (change from baseline) -1.3  (6.4) -17.9  (7.6)
3.Secondary Outcome
Title HDL-cholesterol
Hide Description Change in fasting plasma cholesterol from baseline after chronic supplemenation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame 6 and 12 weeks after supplementation
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: mg/dL
Baseline 28.8  (1.3) 26.8  (1.5)
6 weeks (change from baseline) -0.9  (1.0) 0.2  (0.8)
12 weeks (change from baseline) -0.7  (1.4) 0.2  (0.8)
4.Secondary Outcome
Title Triglycerides
Hide Description Change in fasting plasma triglycerides from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame 6 and 12 weeks after supplementation
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: mg/dL
Baseline 82.1  (7.6) 89.6  (9.0)
6 weeks (change from baseline) -0.6  (2.7) 1.0  (5.9)
12 weeks (change from baseline) -1.0  (5.9) 2.0  (8.5)
5.Secondary Outcome
Title Resting Systolic Blood Pressure
Hide Description Change in resting systolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 6 weeks, and 12 weeks following intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: mmHg
Baseline 121  (3) 117  (3)
6 weeks (change from baseline) -0.8  (1.5) 2.8  (1.7)
12 weeks (change from baseline) 0.2  (2.9) 1.2  (2.4)
6.Secondary Outcome
Title Resting Diastolic Blood Pressure
Hide Description Change in resting diastolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 6 weeks, and 12 weeks following intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: mmHg
Baseline 76.0  (2.1) 75.3  (2.4)
6 weeks (change from baseline) -1.2  (2.4) 5.0  (1.3)
12 weeks (change from baseline) -1.1  (1.7) 2.0  (1.5)
7.Secondary Outcome
Title Urinary F2-isoprostanes
Hide Description Change in resting urinary F2-isoprostanes after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline and 12 weeks following intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: ng/mmol creatinine
Baseline 71.0  (8.1) 58.6  (7.0)
12 weeks 81.6  (7.8) 68.4  (9.0)
8.Secondary Outcome
Title 3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR)
Hide Description Monocyte messenger ribonucleic acid (mRNA) expression normalized to glyceraldehyde-3-phosphate dehydrogenase (GAPDH) after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 12 wk
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: relative expression (HMGR/GAPDH)
Baseline 0.90  (0.06) 0.91  (0.06)
12 weeks 1.16  (0.28) 0.79  (0.12)
9.Secondary Outcome
Title LDL Receptor (LDLR)
Hide Description Monocyte LDL receptor mRNA normalized to glyceraldehyde-3-phosphate dehydrogenase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Change from baseline at 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: relative expression (LDLR/GAPDH)
Baseline 0.90  (0.07) 0.84  (0.07)
12 weeks 0.93  (0.22) 0.88  (0.26)
10.Secondary Outcome
Title LDL Receptor (LDLR) Protein
Hide Description Monocyte LDL receptor protein by Western blot, normalized to β-actin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: relative expression (LDLR/β-actin)
Baseline 1.71  (0.33) 1.45  (0.06)
12 weeks 2.47  (0.80) 1.45  (0.64)
11.Secondary Outcome
Title Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites.
Hide Description Plasma area under the curve of chokeberry polyphenols and their metabolites. Measurement (time 0) began at study baseline. Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule).
Time Frame 0, 0.5, 1, 2, 4, 6, 9, 12, and 24 hours following dose
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule) as this analysis required additional collection time-points that were not utilized in the other arms.
Arm/Group Title Chokeberry Extract Capsule (Acute)
Hide Arm/Group Description:
Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
Overall Number of Participants Analyzed 6
Mean (Standard Error)
Unit of Measure: micrograms x h/mL
Protocatechuic acid 0.054  (0.013)
Hippuric acid 22.350  (4.441)
3-(4-Hydroxyphenyl)propionic acid 2.725  (2.391)
Cyanidin-3-O-glucoside 0.462  (0.170)
Peonidin-3-O-galactoside 0.627  (0.198)
12.Secondary Outcome
Title Urinary Excretion of Polyphenols
Hide Description Urinary excretion of polyphenols, from 0 to 24 h after consumption of extract, area under the curve (AUC) in Chokeberry Extract Capsule (acute) arm only.
Time Frame 0 to 24 h after consumption of extract
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule) as this analysis required additional collection time-points that were not utilized in the other arms.
Arm/Group Title Chokeberry Extract Capsule (Acute)
Hide Arm/Group Description:
Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
Overall Number of Participants Analyzed 6
Mean (Standard Error)
Unit of Measure: mg x h/mg creatinine
Protocatechuic acid 3.682  (0.587)
3,4-dihyrdoxyphenylacetic acid 11.426  (0.881)
Hippuric acid 2429.852  (360.197)
3-(4-hydroxyphenyl)propionic acid 2.299  (0.715)
Cyanidin-3-O-galactoside 0.016  (0.005)
Cyanidin-3-O-glucoside 0.118  (0.070)
Cyanidin-3-O-arabinoside 0.088  (0.031)
Peonidin-3-O-galactoside 0.053  (0.012)
13.Secondary Outcome
Title Adiponectin
Hide Description Fasting plasma adiponectin after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 6 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: micrograms/mL
Baseline 13.2  (1.9) 12.8  (1.5)
6 weeks 14.2  (2.0) 13.8  (1.7)
12 weeks 12.5  (1.6) 13.2  (1.5)
14.Secondary Outcome
Title Interleukin-1 Beta
Hide Description Fasting plasma interleukin-1 beta after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 6 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: pg/mL
Baseline 9.3  (2.4) 16.2  (8.6)
6 weeks 9.5  (2.7) 17.0  (9.7)
12 weeks 10.1  (3.0) 14.7  (7.4)
15.Secondary Outcome
Title Interleukin-6
Hide Description Fasting plasma interleukin-6 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 6 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: pg/mL
Baseline 1.94  (0.34) 4.68  (1.34)
6 weeks 1.87  (0.38) 5.16  (1.54)
12 weeks 1.76  (0.29) 5.34  (1.52)
16.Secondary Outcome
Title Monocyte Chemoattractant Protein-1
Hide Description Fasting plasma monocyte chemoattractant protein-1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 6 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: pg/mL
Baseline 97  (6) 133  (31)
6 weeks 96  (5) 167  (43)
12 weeks 91  (5) 141  (27)
17.Secondary Outcome
Title Tumor Necrosis Factor-alpha
Hide Description Fasting plasma Tumor necrosis factor-alpha after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 6 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: pg/mL
Baseline 4.36  (1.83) 5.90  (1.63)
6 weeks 4.70  (1.89) 6.44  (1.83)
12 weeks 4.86  (1.85) 6.10  (1.72)
18.Secondary Outcome
Title C-reactive Protein
Hide Description Fasting plasma C-reactive protein after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 6 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: pg/mL
Baseline 2.54  (0.60) 2.01  (0.34)
6 weeks 2.18  (0.42) 2.32  (0.39)
12 weeks 2.24  (0.38) 2.29  (0.49)
19.Secondary Outcome
Title Intercellular Adhesion Molecule 1
Hide Description Fasting plasma intercellular adhesion molecule 1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 6 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: ng/mL
Baseline 97.1  (7.2) 96.6  (5.4)
6 weeks 97.6  (7.2) 99.4  (5.7)
12 weeks 100  (8) 97.5  (5.8)
20.Secondary Outcome
Title Soluble Vascular Cell Adhesion Molecule 1
Hide Description Fasting plasma soluble vascular cell adhesion molecule 1 after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 6 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline 585  (23) 601  (31)
6 weeks 604  (23) 622  (31)
12 weeks 604  (26) 599  (27)
21.Secondary Outcome
Title P-selectin
Hide Description Fasting plasma P-selectin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 6 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: ng/mL
Baseline 130  (13) 124  (12)
6 weeks 111  (11) 127  (12)
12 weeks 131  (11) 145  (17)
22.Secondary Outcome
Title Total Antioxidant Capacity
Hide Description Fasting plasma total antioxidant capacity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 6 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: micrograms vitamin C equivalents/mL
Baseline 210  (4) 208  (3)
6 weeks 214  (3) 211  (3)
12 weeks 209  (4) 207  (4)
23.Secondary Outcome
Title Catalase Activity
Hide Description Catalase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 6 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: nmol/min/mL
Baseline 41.7  (1.4) 41.1  (2.1)
6 weeks 35.5  (1.2) 38.7  (1.5)
12 weeks 41.7  (2.3) 41.2  (1.8)
24.Secondary Outcome
Title Glutathione Peroxidase Activity
Hide Description Fasting plasma glutathione peroxidase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 6 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: nmol/min/mL
Baseline 2550  (140) 2550  (140)
6 weeks 2560  (130) 2500  (160)
12 weeks 2470  (110) 2650  (190)
25.Secondary Outcome
Title Superoxide Dismutase Activity
Hide Description Fasting plasma superoxide dismutase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 6 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: units/mL
Baseline 1190  (50) 1180  (40)
6 weeks 1190  (50) 1160  (40)
12 weeks 1160  (60) 1160  (40)
26.Secondary Outcome
Title Urinary Polyphenol Excretion
Hide Description Overnight urinary polyphenol excretion after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 24 25
Median (Inter-Quartile Range)
Unit of Measure: mg/mg creatinine
Protocatechuic acid
1.38
(0.94 to 2.08)
1.20
(0.64 to 2.03)
3,4-dihydroxyphenylacetic acid
5.04
(2.36 to 7.45)
4.56
(2.18 to 9.09)
Hippuric acid
133
(104 to 234)
138
(62 to 292)
Ferulic acid
0.68
(0.24 to 1.20)
0.71
(0.23 to 3.57)
3-(4-hydroxyphenyl)propionic acid
3.91
(0 to 9.95)
3.36
(0 to 9.68)
Cyanidin-3-O-glucoside
0
(0 to 0.055)
0.00907
(0 to 0.1993)
Cyanidin-3-O-galactoside
0
(0 to 0.014)
0.00466
(0 to 0.0341)
Cyanidin-3-O-arabinoside
0
(0 to 0.011)
0
(0 to 0.053)
Peonidin-3-O-galactoside
0
(0 to 0)
0.008
(0 to 0.0106)
Sum anthocyanins
0.014
(0 to 0.091)
0.134
(0.028 to 0.442)
27.Secondary Outcome
Title Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber
Hide Description Energy-adjusted intake based on 3-day dietary recalls, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 22 25
Mean (Standard Error)
Unit of Measure: g/day
Carbohydrate 238  (9) 241  (9)
Protein 89.2  (3.3) 90.3  (3.1)
Fat 27.8  (4.0) 77.6  (29.5)
Fiber 23.5  (1.6) 21.0  (1.5)
28.Secondary Outcome
Title Energy Intake
Hide Description Energy intake reported from 3-day dietary recalls at baseline and 12 weeks, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 22 25
Mean (Standard Error)
Unit of Measure: kcal/d
2230  (735) 1950  (530)
29.Secondary Outcome
Title Energy-adjusted Micronutrient Intake
Hide Description Energy-adjusted micronutrient intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 22 25
Mean (Standard Error)
Unit of Measure: mg/day
Sodium 3490  (160) 3480  (150)
Calcium 947  (58) 1070  (50)
Iron 16.9  (1.3) 16.9  (1.2)
Vitamin D 5.0  (0.9) 7.1  (0.8)
Vitamin C 80.9  (12.9) 90.9  (12.1)
Vitamin E 10.6  (1.1) 10.8  (1.1)
30.Secondary Outcome
Title Polyphenol Intake
Hide Description Energy-adjusted polyphenol intake assessed by 3-day dietary recalls at baseline and 12 weeks, values determined by average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 22 25
Mean (Standard Error)
Unit of Measure: mg/day
Isoflavones 3.9  (2.7) 8.5  (2.6)
Flavanols 73.9  (20.0) 81.7  (18.7)
Flavones 54.1  (29.1) 50.3  (27.2)
Flavanones 28.8  (11.4) 22.4  (10.7)
Flavan-3-ols 20.6  (7.4) 26.0  (6.9)
Anthocyanins 18.2  (5.2) 26.6  (4.8)
Proanthocyanidins 222  (162) 418  (150)
31.Secondary Outcome
Title Intake of Dietary Antioxidant Capacity
Hide Description Energy-adjusted intake of dietary antioxidant capacity determined by 3-day dietary recalls at baseline and 12 weeks. Values reported as average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 22 24
Mean (Standard Error)
Unit of Measure: Vitamin C equivalents
417  (95) 292  (89)
32.Secondary Outcome
Title Energy-adjusted Vitamin A Intake
Hide Description Energy-adjusted vitamin A intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule
Hide Arm/Group Description:

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Overall Number of Participants Analyzed 22 25
Mean (Standard Error)
Unit of Measure: retinol equivalent mcg/day
3280  (740) 2690  (690)
Time Frame During study intervention stage: 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Color-matched Rice Powder Pill Chokeberry Extract Capsule Chokeberry Extract Capsule (Acute)
Hide Arm/Group Description

Color-matched rice powder pill

Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks

Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
All-Cause Mortality
Color-matched Rice Powder Pill Chokeberry Extract Capsule Chokeberry Extract Capsule (Acute)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%)   0/6 (0.00%) 
Hide Serious Adverse Events
Color-matched Rice Powder Pill Chokeberry Extract Capsule Chokeberry Extract Capsule (Acute)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%)   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Color-matched Rice Powder Pill Chokeberry Extract Capsule Chokeberry Extract Capsule (Acute)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%)   0/6 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Bradley Bolling
Organization: University of Wisconsin-Madison, Department of Food Science
Phone: 608-890-0212
EMail: bwbolling@wisc.edu
Layout table for additonal information
Responsible Party: Bradley Bolling, University of Connecticut
ClinicalTrials.gov Identifier: NCT01541826    
Other Study ID Numbers: H11-311
120068 ( Other Identifier: University of Connecticut )
First Submitted: February 24, 2012
First Posted: March 1, 2012
Results First Submitted: December 12, 2016
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017