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Mars Flavanol Exercise and Cognitive Function Study

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ClinicalTrials.gov Identifier: NCT01180127
Recruitment Status : Completed
First Posted : August 11, 2010
Results First Posted : January 27, 2015
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
Mars, Inc.
Information provided by (Responsible Party):
Richard Sloan, New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Investigator);   Primary Purpose: Basic Science
Condition Cognitive Function
Interventions Dietary Supplement: Flavanol containing food product
Behavioral: Aerobic training
Dietary Supplement: Food product lacking flavanol
Behavioral: Wait list control
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Exercise, Dietary Intervention no Exercise, Dietary Intervention Exercise, Food Additive Lacking Flavanol Wait List Control Food Additive Without Flavanol
Hide Arm/Group Description

aerobic training and flavanol containing food product

Flavanol containing food product: 12 weeks, 2X/day, 20g serving

Aerobic training: 4X/week, 1 hour/session at 75% maximum HR

wait list control plus flavanol containing food product for 12 weeks

Flavanol containing food product: 12 weeks, 2X/day, 20g serving

Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise

aerobic training plus food additive without flavanol

Aerobic training: 4X/week, 1 hour/session at 75% maximum HR

Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol

12 weeks of wait list control status plus food additive without the flavanol containing food product

Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol

Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise

Period Title: Overall Study
Started 10 11 10 10
Completed 8 11 9 9
Not Completed 2 0 1 1
Arm/Group Title Exercise, Dietary Intervention no Exercise, Dietary Intervention Exercise, Food Additive Lacking Flavonol Wait List Control Food Additive Without Flavonol Total
Hide Arm/Group Description

aerobic training and flavanol containing food product

Flavanol containing food product: 12 weeks, 2X/day, 20g serving

Aerobic training: 4X/week, 1 hour/session at 75% maximum HR

wait list control plus flavanol containing food product for 12 weeks

Flavanol containing food product: 12 weeks, 2X/day, 20g serving

Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise

aerobic training plus food additive without flavanol

Aerobic training: 4X/week, 1 hour/session at 75% maximum HR

Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol

12 weeks of wait list control status plus food additive without the flavanol containing food product

Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol

Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise

Total of all reporting groups
Overall Number of Baseline Participants 10 11 10 10 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 11 participants 10 participants 10 participants 41 participants
58.4  (4.9) 57.5  (5.34) 56.6  (5.56) 56.6  (3.7) 57.5  (4.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 10 participants 10 participants 41 participants
Female
8
  80.0%
7
  63.6%
7
  70.0%
7
  70.0%
29
  70.7%
Male
2
  20.0%
4
  36.4%
3
  30.0%
3
  30.0%
12
  29.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 10 participants 10 participants 41 participants
Hispanic or Latino
1
  10.0%
2
  18.2%
3
  30.0%
4
  40.0%
10
  24.4%
Not Hispanic or Latino
9
  90.0%
9
  81.8%
7
  70.0%
6
  60.0%
31
  75.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 10 participants 10 participants 41 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  10.0%
0
   0.0%
0
   0.0%
1
  10.0%
2
   4.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  10.0%
2
  18.2%
2
  20.0%
2
  20.0%
7
  17.1%
White
7
  70.0%
6
  54.5%
6
  60.0%
4
  40.0%
23
  56.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  10.0%
3
  27.3%
2
  20.0%
3
  30.0%
9
  22.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 11 participants 10 participants 10 participants 41 participants
10 11 10 10 41
1.Primary Outcome
Title CBV-fMRI (Cerebral Blood Volume-functional Magnetic Resonance Imaging)
Hide Description In steady state conditions, CBV is an indirect measure of basal metabolism in the brain. CBV-fMRI is a technique that generates maps of basal metabolism across different brain regions
Time Frame Up to 12 weeks after exercise/dietary intervention exposure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in the exercise, food additive lacking flavanol arm, and one subject in the wait list control food additive without flavanol arm had non useable data for this outcome which is why there are only 8 subjects analyzed in those two arms rather than 9.
Arm/Group Title Exercise, Dietary Intervention no Exercise, Dietary Intervention Exercise, Food Additive Lacking Flavanol Wait List Control Food Additive Without Flavanol
Hide Arm/Group Description:

aerobic training and flavanol containing food product

Flavanol containing food product: 12 weeks, 2X/day, 20g serving

Aerobic training: 4X/week, 1 hour/session at 75% maximum HR

wait list control plus flavanol containing food product for 12 weeks

Flavanol containing food product: 12 weeks, 2X/day, 20g serving

Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise

aerobic training plus food additive without flavanol

Aerobic training: 4X/week, 1 hour/session at 75% maximum HR

Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol

12 weeks of wait list control status plus food additive without the flavanol containing food product

Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol

Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise

Overall Number of Participants Analyzed 8 11 8 8
Mean (Standard Deviation)
Unit of Measure: percent CBV in a brain region
Baseline 3.43  (1.43) 2.55  (0.45) 2.89  (0.70) 3.38  (0.52)
12 weeks 4.58  (1.66) 4.48  (1.31) 2.91  (0.81) 2.60  (0.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise, Dietary Intervention, no Exercise, Dietary Intervention, Exercise, Food Additive Lacking Flavanol, Wait List Control Food Additive Without Flavanol
Comments Repeated measures ANOVA for the interaction of time (baseline vs 12 week) and flavanol group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0001
Comments [Not Specified]
Method Repeated measures ANOVA
Comments [Not Specified]
2.Primary Outcome
Title ModBent (Modified Benton Visual Retention Test)
Hide Description This is an object recognition task. Participants view a complex stimulus, then are asked to select which one of two objects was identical to the studied stimulus. After a series of these matching trials, during the subsequent recognition trials participants are shown serially individual complex objects and asked to indicate whether the object was identical to any of the target stimuli viewed during the matching trials. Their reaction time for correct responses, measured in milliseconds, is the unit of measurement.
Time Frame Up to 12 weeks after exercise/dietary intervention exposure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in the exercise, dietary intervention and one subject in the no exercise, dietary intervention group had outlying (larger than 3 standard deviation from mean) ModBent values that were deleted and hence those groups have 7 and 10 subjects analyzed rather than 8 and 11 respectively.
Arm/Group Title Exercise, Dietary Intervention no Exercise, Dietary Intervention Exercise, Food Additive Lacking Flavonol Wait List Control Food Additive Without Flavonol
Hide Arm/Group Description:

aerobic training and flavonol containing food product

Flavonol containing food product: 12 weeks, 2X/day, 20g serving

Aerobic training: 4X/week, 1 hour/session at 75% maximum HR

wait list control plus flavonol containing food product for 12 weeks

Flavonol containing food product: 12 weeks, 2X/day, 20g serving

Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise

aerobic training plus food additive without flavonol

Aerobic training: 4X/week, 1 hour/session at 75% maximum HR

Placebo food additive: 20 g serving, 2X/day, food additive lacking flavonol

12 weeks of wait list control status plus food additive without the flavonol containing food product

Placebo food additive: 20 g serving, 2X/day, food additive lacking flavonol

Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise

Overall Number of Participants Analyzed 7 10 9 9
Mean (Standard Deviation)
Unit of Measure: milliseconds
Baseline 1945  (584) 2296  (1056) 2291  (515) 2347  (919)
12 weeks 1867  (478) 2009  (815) 2560  (1086) 2794  (1298)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise, Dietary Intervention, no Exercise, Dietary Intervention, Exercise, Food Additive Lacking Flavonol, Wait List Control Food Additive Without Flavonol
Comments ANCOVA used to test main effect of flavanol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments The ANCOVA model included a main effect for both flavanol and exercise, so this p-value is for the effect of flavanol on Modbent controlling for baseline Modbent and exercise
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exercise, Dietary Intervention, no Exercise, Dietary Intervention, Exercise, Food Additive Lacking Flavonol, Wait List Control Food Additive Without Flavonol
Comments ANCOVA used to test main effect of exercise
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.815
Comments The ANCOVA included both a main effect for flavanol and exercise, so this p-value is for the test of exercise controlling for baseline Modbent and flavanol
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Modified Rey Auditory Verbal Learning Test
Hide Description Participants are read a list of words over three learning trials and the subject is asked to free recall as many words as possible after each trial. These 3 trials are followed by 1 learning trial of a distracter list and then a short delayed free recall trial of the initial list. After approximately 60-minutes, subjects are asked to freely recall words from the initial list, then to recall words form the distracter list, and then complete a forced-choice recognition trial. A source memory trial is administered in which subjects are read each presented word and then asked to identify whether they were initially presented during the 3 learning trials or during the distracter trial. Measured as a retention score (ratio) for which the number of words recalled after the short delay is divided by the number of words recalled on the third learning trial.
Time Frame Up to 12 weeks after exercise/dietary intervention exposure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 4 subjects (1 in exercise, dietary intervention; 2 in no exercise, dietary intervention, and 1 in exercise, food additive lacking flavanol) who did not have useable data and are thus not included in analyses.
Arm/Group Title Exercise, Dietary Intervention no Exercise, Dietary Intervention Exercise, Food Additive Lacking Flavanol Wait List Control Food Additive Without Flavanol
Hide Arm/Group Description:

aerobic training and flavanol containing food product

Flavanol containing food product: 12 weeks, 2X/day, 20g serving

Aerobic training: 4X/week, 1 hour/session at 75% maximum HR

wait list control plus flavanol containing food product for 12 weeks

Flavanol containing food product: 12 weeks, 2X/day, 20g serving

Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise

aerobic training plus food additive without flavanol

Aerobic training: 4X/week, 1 hour/session at 75% maximum HR

Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol

12 weeks of wait list control status plus food additive without the flavanol containing food product

Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol

Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise

Overall Number of Participants Analyzed 7 9 8 9
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline 0.76  (0.21) 0.69  (0.19) 0.80  (0.19) 0.89  (0.11)
12 weeks 0.83  (0.08) 0.65  (0.25) 0.76  (0.23) 0.87  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise, Dietary Intervention, no Exercise, Dietary Intervention, Exercise, Food Additive Lacking Flavanol, Wait List Control Food Additive Without Flavanol
Comments ANCOVA for testing main effect of flavanol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.853
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exercise, Dietary Intervention, no Exercise, Dietary Intervention, Exercise, Food Additive Lacking Flavanol, Wait List Control Food Additive Without Flavanol
Comments ANCOVA for testing main effect of exercise
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.581
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title VO2max
Hide Description measured at randomization, i.e., before exposure to the intervention, and then again after completion of the 12-week intervention
Time Frame Up to 12 weeks after exercise/dietary intervention exposure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in the exercise, dietary intervention and one subject in the exercise, food additive lacking flavanol group had unusable data for this outcome and thus are not included in these analyses.
Arm/Group Title Exercise, Dietary Intervention no Exercise, Dietary Intervention Exercise, Food Additive Lacking Flavanol Wait List Control Food Additive Without Flavanol
Hide Arm/Group Description:

aerobic training and flavanol containing food product

Flavanol containing food product: 12 weeks, 2X/day, 20g serving

Aerobic training: 4X/week, 1 hour/session at 75% maximum HR

wait list control plus flavanol containing food product for 12 weeks

Flavanol containing food product: 12 weeks, 2X/day, 20g serving

Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise

aerobic training plus food additive without flavanol

Aerobic training: 4X/week, 1 hour/session at 75% maximum HR

Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol

12 weeks of wait list control status plus food additive without the flavanol containing food product

Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol

Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise

Overall Number of Participants Analyzed 7 11 8 9
Mean (Standard Deviation)
Unit of Measure: mL/(kg·min)
Baseline 25.6  (3.77) 26.26  (4.62) 25.1  (4.36) 23.94  (3.81)
12 weeks 27.8  (4.33) 25.36  (3.66) 25.98  (6.57) 25.44  (5.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise, Dietary Intervention, no Exercise, Dietary Intervention, Exercise, Food Additive Lacking Flavanol, Wait List Control Food Additive Without Flavanol
Comments ANCOVA was used to test for an exercise effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.237
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exercise, Dietary Intervention no Exercise, Dietary Intervention Exercise, Food Additive Lacking Flavonol Wait List Control Food Additive Without Flavonol
Hide Arm/Group Description

aerobic training and flavanol containing food product

Flavanol containing food product: 12 weeks, 2X/day, 20g serving

Aerobic training: 4X/week, 1 hour/session at 75% maximum HR

wait list control plus flavanol containing food product for 12 weeks

Flavanol containing food product: 12 weeks, 2X/day, 20g serving

Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise

aerobic training plus food additive without flavanol

Aerobic training: 4X/week, 1 hour/session at 75% maximum HR

Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol

12 weeks of wait list control status plus food additive without the flavanol containing food product

Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol

Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise

All-Cause Mortality
Exercise, Dietary Intervention no Exercise, Dietary Intervention Exercise, Food Additive Lacking Flavonol Wait List Control Food Additive Without Flavonol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Exercise, Dietary Intervention no Exercise, Dietary Intervention Exercise, Food Additive Lacking Flavonol Wait List Control Food Additive Without Flavonol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/11 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Exercise, Dietary Intervention no Exercise, Dietary Intervention Exercise, Food Additive Lacking Flavonol Wait List Control Food Additive Without Flavonol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/11 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Richard Sloan
Organization: Columbia University Medical Center, Division of Behavioral Medicine in Psychiatry
Phone: 646-774-8940
Responsible Party: Richard Sloan, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01180127     History of Changes
Other Study ID Numbers: 5804
First Submitted: May 21, 2010
First Posted: August 11, 2010
Results First Submitted: December 23, 2014
Results First Posted: January 27, 2015
Last Update Posted: December 5, 2018