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Trial record 3 of 4 for:    21475195 [PUBMED-IDS]

Low Fat Vegan or American Heart Association Diets & Cardiovascular Risk in Obese 9-18 y.o. With Elevated Cholesterol

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: NCT01817491
Recruitment Status : Completed
First Posted : March 25, 2013
Results First Posted : June 8, 2018
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
michael macknin, The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Cardiovascular Disease
Hypercholesterolemia
Obesity
Fatty Liver
Interventions Other: American Heart Association Diet
Other: Reduced Fat Vegan Diet
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Reduced Fat Vegan Diet American Heart Association Diet
Hide Arm/Group Description

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet

Period Title: Overall Study
Started 32 28
Completed 28 28
Not Completed 4 0
Arm/Group Title Reduced Fat Vegan Diet American Heart Association Diet Total
Hide Arm/Group Description

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet

Total of all reporting groups
Overall Number of Baseline Participants 32 28 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 28 participants 60 participants
<=18 years
16
  50.0%
14
  50.0%
30
  50.0%
Between 18 and 65 years
16
  50.0%
14
  50.0%
30
  50.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 32 participants 28 participants 60 participants
Adolescents
15
(9.0 to 18.0)
15
(9.0 to 18.0)
15
(9.0 to 18.0)
Parents
46.5
(37.0 to 61.0)
46.0
(35.0 to 51.0)
46.25
(35.0 to 61.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 28 participants 60 participants
Female
21
  65.6%
19
  67.9%
40
  66.7%
Male
11
  34.4%
9
  32.1%
20
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 28 participants 60 participants
32 28 60
1.Primary Outcome
Title Change in Body Mass Index BMI Percentile
Hide Description [Not Specified]
Time Frame baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children only
Arm/Group Title Reduced Fat Vegan Diet American Heart Association Diet
Hide Arm/Group Description:

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet

Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: BMI percentile
Children -1.12  (1.69) -0.08  (0.42)
Parents -1.29  (1.14) -0.73  (0.92)
2.Primary Outcome
Title Children Change in BMI Z Score
Hide Description Body mass index z-scores, also called BMI standard deviation (s.d.) scores, are measures of relative weight adjusted for child age and sex. Given a child's age, sex, BMI, and an appropriate reference standard, a BMI z-score (or its equivalent BMI-for-age percentile) can be determined. Negative BMI z-scores indicate a BMI that is lower than the population mean, while positive BMI scores indicate a value that is higher than the population mean. A decrease in the BMI z-score over time indicate a lowering of the BMI. Z-scores of 1.03 and 1.64 correspond to the 85th and 95th percentiles of BMI-for-age, which are the definitions of overweight and obesity in children.
Time Frame baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children only
Arm/Group Title Reduced Fat Vegan Diet American Heart Association Diet
Hide Arm/Group Description:

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet

Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Z Score
-0.14  (0.16) -0.03  (0.07)
3.Primary Outcome
Title Change in Blood Pressure (BP)
Hide Description [Not Specified]
Time Frame baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children and parents
Arm/Group Title Reduced Fat Vegan Diet American Heart Association Diet
Hide Arm/Group Description:

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet

Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: mm Hg
Children Systolic BP Number Analyzed 14 participants 14 participants
-6.43  (8.86) -5.14  (17.64)
Parents Systolic BP Number Analyzed 14 participants 14 participants
-7.96  (12.28) -3.14  (14.42)
Children Diastolic BP Number Analyzed 14 participants 14 participants
-2.61  (10.25) -4.36  (14.67)
Parent Diastolic BP Number Analyzed 14 participants 14 participants
-3.46  (11.06) -6.64  (12.19)
4.Primary Outcome
Title Change in Weight
Hide Description [Not Specified]
Time Frame baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children and parents
Arm/Group Title Reduced Fat Vegan Diet American Heart Association Diet
Hide Arm/Group Description:

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet

Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: kg
Children Number Analyzed 14 participants 14 participants
-3.05  (3.27) -1.55  (1.83)
Parents Number Analyzed 14 participants 14 participants
-3.64  (3.41) -2.01  (2.66)
5.Primary Outcome
Title Change in Circumference
Hide Description [Not Specified]
Time Frame baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children and parents
Arm/Group Title Reduced Fat Vegan Diet American Heart Association Diet
Hide Arm/Group Description:

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet

Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: cm
Children Waist Circumference Number Analyzed 14 participants 14 participants
-1.53  (3.01) -2.96  (4.04)
Parents Waist Circumference Number Analyzed 14 participants 14 participants
-1.94  (5.80) -0.49  (5.73)
Children Midarm Circumference Number Analyzed 14 participants 14 participants
-2.02  (2.17) -1.14  (1.63)
Parents Midarm Circumference Number Analyzed 14 participants 14 participants
-1.32  (2.06) 0.35  (3.16)
6.Primary Outcome
Title Change in PAQ (Physical Activity Questionnaire)
Hide Description PAQ self reported questions based on activity level from 1 (low activity) to 5 (high activity), overall PAQ score is a mean of the questions.
Time Frame baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children
Arm/Group Title Reduced Fat Vegan Diet American Heart Association Diet
Hide Arm/Group Description:

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet

Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.22  (0.53) -0.16  (0.54)
7.Primary Outcome
Title Change in Lipid Profile
Hide Description [Not Specified]
Time Frame baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children and Parents
Arm/Group Title Reduced Fat Vegan Diet American Heart Association Diet
Hide Arm/Group Description:

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet

Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: mg/dL
total cholesterol children Number Analyzed 14 participants 14 participants
-22.50  (36.31) -16.50  (28.19)
triglycerides children Number Analyzed 14 participants 14 participants
-25.50  (95.26) -13.14  (36.19)
high-density lipoprotein cholesterol children Number Analyzed 14 participants 14 participants
-5.93  (9.37) -2.93  (3.71)
low-density lipoprotein cholesterol children Number Analyzed 14 participants 14 participants
-13.14  (35.54) -11.00  (23.31)
total cholesterol parents Number Analyzed 14 participants 14 participants
-33.79  (30.84) -7.14  (24.93)
triglycerides parents Number Analyzed 14 participants 14 participants
6.21  (41.71) 16.86  (36.86)
high-density lipoprotein cholesterol parents Number Analyzed 14 participants 14 participants
-8.14  (41.71) 16.86  (36.86)
low-density lipoprotein cholesterol parents Number Analyzed 14 participants 14 participants
-27.00  (26.72) -5.50  (20.89)
8.Primary Outcome
Title Change in Glucose
Hide Description [Not Specified]
Time Frame baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children and Parents
Arm/Group Title Reduced Fat Vegan Diet American Heart Association Diet
Hide Arm/Group Description:

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet

Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: mg/dL
Children Number Analyzed 14 participants 14 participants
0.93  (6.01) -.64  (5.02)
Parent Number Analyzed 14 participants 14 participants
4.93  (24.65) -5.43  (12.40)
9.Primary Outcome
Title Change in hsCRP (High-sensitivity C-reactive Protein)
Hide Description [Not Specified]
Time Frame baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children and Parents
Arm/Group Title Reduced Fat Vegan Diet American Heart Association Diet
Hide Arm/Group Description:

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet

Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: mg/L
Children Number Analyzed 14 participants 14 participants
-2.09  (7.10) 2.78  (8.76)
Parent Number Analyzed 14 participants 14 participants
-0.24  (1.36) 0.21  (1.90)
10.Primary Outcome
Title Change in Liver Enzymes
Hide Description [Not Specified]
Time Frame baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children and Parents
Arm/Group Title Reduced Fat Vegan Diet American Heart Association Diet
Hide Arm/Group Description:

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet

Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: U/L
alanine aminotransferase (ALT) children Number Analyzed 14 participants 14 participants
0.79  (14.35) -1.14  (3.46)
aspartate aminotransferase (AST) children Number Analyzed 14 participants 14 participants
2.79  (8.96) 0.00  (4.69)
alanine aminotransferase (ALT) parents Number Analyzed 14 participants 14 participants
0.86  (7.01) 4.57  (9.69)
aspartate aminotransferase (AST) parents Number Analyzed 14 participants 14 participants
0.14  (5.70) 4.43  (6.73)
11.Primary Outcome
Title Change in IL-6 (Interleukin-6)
Hide Description [Not Specified]
Time Frame baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children and Parents
Arm/Group Title Reduced Fat Vegan Diet American Heart Association Diet
Hide Arm/Group Description:

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet

Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: pg/ml
Children Number Analyzed 14 participants 14 participants
-0.17  (0.89) -0.19  (3.14)
Parent Number Analyzed 14 participants 14 participants
0.16  (0.90) -0.19  (0.85)
12.Primary Outcome
Title Change in MPO (Myeloperoxidase)
Hide Description [Not Specified]
Time Frame baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children and Parents
Arm/Group Title Reduced Fat Vegan Diet American Heart Association Diet
Hide Arm/Group Description:

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet

Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: pmol/L
Children Number Analyzed 14 participants 14 participants
-75.34  (37.34) -69.23  (72.92)
Parent Number Analyzed 14 participants 14 participants
16.91  (110.66) 1.78  (45.93)
13.Primary Outcome
Title Change in HgbA1c (Hemoglobin A1c)
Hide Description [Not Specified]
Time Frame baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children and Parents
Arm/Group Title Reduced Fat Vegan Diet American Heart Association Diet
Hide Arm/Group Description:

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet

Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: percentage
Children Number Analyzed 14 participants 14 participants
0.17  (0.17) 0.21  (0.12)
Parent Number Analyzed 14 participants 14 participants
-0.16  (0.16) 0.14  (0.49)
14.Primary Outcome
Title Change in Insulin
Hide Description [Not Specified]
Time Frame baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children and Parents
Arm/Group Title Reduced Fat Vegan Diet American Heart Association Diet
Hide Arm/Group Description:

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet

Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: uU/ml
Children Number Analyzed 14 participants 14 participants
-5.42  (5.68) 3.16  (25.62)
Parents Number Analyzed 14 participants 14 participants
-3.11  (8.56) -3.15  (5.47)
15.Secondary Outcome
Title PB/AHA - Adjusted Mean Difference BMI
Hide Description [Not Specified]
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children and Parents
Arm/Group Title PB/AHA
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 56
Mean (95% Confidence Interval)
Unit of Measure: percentile
Children Change in BMI Number Analyzed 28 participants
-1.17
(-2.2 to -0.14)
Parents Change in BMI Number Analyzed 28 participants
-0.69
(-1.47 to 0.09)
16.Secondary Outcome
Title PB/AHA - Adjusted Mean Difference BMI Z Score Children
Hide Description [Not Specified]
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children
Arm/Group Title PB/AHA
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 28
Mean (95% Confidence Interval)
Unit of Measure: Z score
-0.13
(-0.24 to -0.03)
17.Secondary Outcome
Title PB/AHA - Adjusted Mean BP
Hide Description [Not Specified]
Time Frame Baseline, 4 weeks
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Children and parents
Arm/Group Title PB/AHA
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 56
Mean (95% Confidence Interval)
Unit of Measure: ratio
Children adj mean ratio systolic BP Number Analyzed 28 participants
1.87
(-4.41 to 8.15)
Children adj mean ratio diastolic BP Number Analyzed 28 participants
1.01
(0.92 to 1.11)
parents adj mean ratio systolic BP Number Analyzed 28 participants
0.97
(0.89 to 1.05)
parents adj mean ratio diastolic BP Number Analyzed 28 participants
1.03
(0.94 to 1.13)
18.Secondary Outcome
Title PB/AHA - Adjusted Mean Difference Weight
Hide Description [Not Specified]
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children and Parents
Arm/Group Title PB/AHA
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 56
Mean (95% Confidence Interval)
Unit of Measure: kg
Children Weight Number Analyzed 28 participants
-1.71
(-3.80 to 0.39)
Parents Weight Number Analyzed 28 participants
-1.95
(-4.16 to 0.26)
19.Secondary Outcome
Title PB/AHA - Adjusted Mean Difference Circumference
Hide Description [Not Specified]
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children and Parents
Arm/Group Title PB/AHA
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 56
Mean (95% Confidence Interval)
Unit of Measure: cm
children waist circumference Number Analyzed 28 participants
1.32
(-1.66 to 4.30)
parents waist circumference Number Analyzed 28 participants
-1.14
(-5.75 to 3.48)
children arm circumference Number Analyzed 28 participants
-1.25
(-2.61 to 0.11)
parents arm circumference Number Analyzed 28 participants
-1.68
(-3.80 to 0.44)
20.Secondary Outcome
Title PB/AHA - Adjusted Mean Difference PAQ Children
Hide Description PAQ self reported questions based on activity level from 1 (low activity) to 5 (high activity), overall PAQ score is a mean of the questions.
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children
Arm/Group Title PB/AHA
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 28
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.39
(-0.02 to 0.8)
21.Secondary Outcome
Title PB/AHA - Adjusted Mean Lipid Profile
Hide Description [Not Specified]
Time Frame Baseline, 4 weeks
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Children and parents
Arm/Group Title PB/AHA
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 56
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
CHOL children Number Analyzed 28 participants
-10.34
(-36.48 to 15.8)
TRIG children Number Analyzed 28 participants
1.01
(0.77 to 1.32)
HDL children Number Analyzed 28 participants
0.17
(-5.07 to 5.4)
LDL children Number Analyzed 28 participants
0.95
(0.8 to 1.13)
CHOL parents Number Analyzed 28 participants
-27.29
(-48.68 to -5.9)
TRIG parents Number Analyzed 28 participants
0.95
(0.76 to 1.19)
HDL parents Number Analyzed 28 participants
0.94
(0.87 to 1.02)
LDL parents Number Analyzed 28 participants
-21.92
(-40.37 to -3.46)
22.Secondary Outcome
Title PB/AHA - Adjusted Mean Ratio Glucose
Hide Description [Not Specified]
Time Frame Baseline, 4 weeks
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Hide Analysis Population Description
Children and Parents
Arm/Group Title PB/AHA
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 56
Mean (95% Confidence Interval)
Unit of Measure: ratio
Children Number Analyzed 28 participants
1.01
(0.96 to 1.05)
Parents Number Analyzed 28 participants
1.06
(0.97 to 1.16)
23.Secondary Outcome
Title PB/AHA - Adjusted Mean Ratio hsCRP
Hide Description [Not Specified]
Time Frame Baseline, 4 weeks
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Hide Analysis Population Description
Children and Parents
Arm/Group Title PB/AHA
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 56
Mean (95% Confidence Interval)
Unit of Measure: ratio
Children Number Analyzed 28 participants
0.46
(0.21 to 1)
Parents Number Analyzed 28 participants
0.68
(0.44 to 1.07)
24.Secondary Outcome
Title PB/AHA - Adjusted Mean Ratio Liver Enzymes
Hide Description [Not Specified]
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children and Parents
Arm/Group Title PB/AHA
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 56
Mean (95% Confidence Interval)
Unit of Measure: ratio
ALT children Number Analyzed 28 participants
1
(0.76 to 1.32)
AST children Number Analyzed 28 participants
1.13
(0.92 to 1.4)
ALT parents Number Analyzed 28 participants
0.85
(0.67 to 1.08)
AST parents Number Analyzed 28 participants
0.83
(0.68 to 1.03)
25.Secondary Outcome
Title PB/AHA - Adjusted Mean Ratio IL-6
Hide Description [Not Specified]
Time Frame Baseline, 4 weeks
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Hide Analysis Population Description
Children and Parents
Arm/Group Title PB/AHA
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 56
Mean (95% Confidence Interval)
Unit of Measure: ratio
Children Number Analyzed 28 participants
0.26
(0.05 to 1.37)
Parents Number Analyzed 28 participants
1.14
(0.83 to 1.57)
26.Secondary Outcome
Title PB/AHA - Adjusted Mean Ratio MPO
Hide Description [Not Specified]
Time Frame Baseline, 4 weeks
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Hide Analysis Population Description
Children and Parents
Arm/Group Title PB/AHA
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 56
Mean (95% Confidence Interval)
Unit of Measure: ratio
Children Number Analyzed 28 participants
0.95
(0.79 to 1.13)
Parents Number Analyzed 28 participants
0.93
(0.8 to 1.1)
27.Secondary Outcome
Title PB/AHA - Adjusted Mean Ratio HgbA1c
Hide Description [Not Specified]
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Children and Parents
Arm/Group Title PB/AHA
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 56
Mean (95% Confidence Interval)
Unit of Measure: ratio
Children Number Analyzed 28 participants
0.99
(0.97 to 1.01)
Parents Number Analyzed 28 participants
0.96
(0.92 to 1)
28.Secondary Outcome
Title PB/AHA - Adjusted Mean Ratio Insulin
Hide Description [Not Specified]
Time Frame Baseline, 4 weeks
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Hide Analysis Population Description
Children and Parents
Arm/Group Title PB/AHA
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 56
Mean (95% Confidence Interval)
Unit of Measure: ratio
Children Number Analyzed 28 participants
0.7
(0.43 to 1.12)
Parents Number Analyzed 28 participants
0.87
(0.67 to 1.13)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Reduced Fat Vegan Diet American Heart Association Diet
Hide Arm/Group Description

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet

All-Cause Mortality
Reduced Fat Vegan Diet American Heart Association Diet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Reduced Fat Vegan Diet American Heart Association Diet
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Reduced Fat Vegan Diet American Heart Association Diet
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/28 (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
Name/Title: Michael Macknin, MD
Organization: Cleveland Clinic
Phone: 216 444-5512
Publications:
Esselstyn R. The Engine 2 Diet How It All Began. In Esselstyn R "The Engine 2 Diet". New York, Boston: Wellness Central Hachette Book Group, 2009:15-30
Responsible Party: michael macknin, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01817491     History of Changes
Other Study ID Numbers: 12-1298
First Submitted: March 21, 2013
First Posted: March 25, 2013
Results First Submitted: January 11, 2017
Results First Posted: June 8, 2018
Last Update Posted: February 20, 2019