Trial Outcomes & Findings for Mars Flavanol Exercise and Cognitive Function Study (NCT NCT01180127)
NCT ID: NCT01180127
Last Updated: 2018-12-05
Results Overview
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
COMPLETED
NA
41 participants
Up to 12 weeks after exercise/dietary intervention exposure
2018-12-05
Participant Flow
Participant milestones
| Measure |
Exercise, Dietary Intervention
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
|
no Exercise, Dietary Intervention
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
|
Exercise, Food Additive Lacking Flavanol
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
|
Wait List Control Food Additive Without 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 Study
STARTED
|
10
|
11
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
11
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mars Flavanol Exercise and Cognitive Function Study
Baseline characteristics by cohort
| Measure |
Exercise, Dietary Intervention
n=10 Participants
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
|
no Exercise, Dietary Intervention
n=11 Participants
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
|
Exercise, Food Additive Lacking Flavonol
n=10 Participants
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
|
Wait List Control Food Additive Without Flavonol
n=10 Participants
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
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
57.5 years
STANDARD_DEVIATION 5.34 • n=7 Participants
|
56.6 years
STANDARD_DEVIATION 5.56 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 3.7 • n=4 Participants
|
57.5 years
STANDARD_DEVIATION 4.89 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
41 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeks after exercise/dietary intervention exposurePopulation: 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.
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
Outcome measures
| Measure |
no Exercise, Dietary Intervention
n=11 Participants
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
|
Exercise, Food Additive Lacking Flavanol
n=8 Participants
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
|
Wait List Control Food Additive Without Flavanol
n=8 Participants
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
|
Exercise, Dietary Intervention
n=8 Participants
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
|
|---|---|---|---|---|
|
CBV-fMRI (Cerebral Blood Volume-functional Magnetic Resonance Imaging)
12 weeks
|
4.48 percent CBV in a brain region
Standard Deviation 1.31
|
2.91 percent CBV in a brain region
Standard Deviation 0.81
|
2.60 percent CBV in a brain region
Standard Deviation 0.59
|
4.58 percent CBV in a brain region
Standard Deviation 1.66
|
|
CBV-fMRI (Cerebral Blood Volume-functional Magnetic Resonance Imaging)
Baseline
|
2.55 percent CBV in a brain region
Standard Deviation 0.45
|
2.89 percent CBV in a brain region
Standard Deviation 0.70
|
3.38 percent CBV in a brain region
Standard Deviation 0.52
|
3.43 percent CBV in a brain region
Standard Deviation 1.43
|
PRIMARY outcome
Timeframe: Up to 12 weeks after exercise/dietary intervention exposurePopulation: 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.
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.
Outcome measures
| Measure |
no Exercise, Dietary Intervention
n=10 Participants
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
|
Exercise, Food Additive Lacking Flavanol
n=9 Participants
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
|
Wait List Control Food Additive Without Flavanol
n=9 Participants
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
|
Exercise, Dietary Intervention
n=7 Participants
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
|
|---|---|---|---|---|
|
ModBent (Modified Benton Visual Retention Test)
Baseline
|
2296 milliseconds
Standard Deviation 1056
|
2291 milliseconds
Standard Deviation 515
|
2347 milliseconds
Standard Deviation 919
|
1945 milliseconds
Standard Deviation 584
|
|
ModBent (Modified Benton Visual Retention Test)
12 weeks
|
2009 milliseconds
Standard Deviation 815
|
2560 milliseconds
Standard Deviation 1086
|
2794 milliseconds
Standard Deviation 1298
|
1867 milliseconds
Standard Deviation 478
|
SECONDARY outcome
Timeframe: Up to 12 weeks after exercise/dietary intervention exposurePopulation: 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.
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.
Outcome measures
| Measure |
no Exercise, Dietary Intervention
n=9 Participants
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
|
Exercise, Food Additive Lacking Flavanol
n=8 Participants
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
|
Wait List Control Food Additive Without Flavanol
n=9 Participants
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
|
Exercise, Dietary Intervention
n=7 Participants
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
|
|---|---|---|---|---|
|
Modified Rey Auditory Verbal Learning Test
Baseline
|
0.69 ratio
Standard Deviation 0.19
|
0.80 ratio
Standard Deviation 0.19
|
0.89 ratio
Standard Deviation 0.11
|
0.76 ratio
Standard Deviation 0.21
|
|
Modified Rey Auditory Verbal Learning Test
12 weeks
|
0.65 ratio
Standard Deviation 0.25
|
0.76 ratio
Standard Deviation 0.23
|
0.87 ratio
Standard Deviation 0.21
|
0.83 ratio
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: Up to 12 weeks after exercise/dietary intervention exposurePopulation: 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.
measured at randomization, i.e., before exposure to the intervention, and then again after completion of the 12-week intervention
Outcome measures
| Measure |
no Exercise, Dietary Intervention
n=11 Participants
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
|
Exercise, Food Additive Lacking Flavanol
n=8 Participants
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
|
Wait List Control Food Additive Without Flavanol
n=9 Participants
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
|
Exercise, Dietary Intervention
n=7 Participants
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
|
|---|---|---|---|---|
|
VO2max
Baseline
|
26.26 mL/(kg·min)
Standard Deviation 4.62
|
25.1 mL/(kg·min)
Standard Deviation 4.36
|
23.94 mL/(kg·min)
Standard Deviation 3.81
|
25.6 mL/(kg·min)
Standard Deviation 3.77
|
|
VO2max
12 weeks
|
25.36 mL/(kg·min)
Standard Deviation 3.66
|
25.98 mL/(kg·min)
Standard Deviation 6.57
|
25.44 mL/(kg·min)
Standard Deviation 5.51
|
27.8 mL/(kg·min)
Standard Deviation 4.33
|
Adverse Events
Exercise, Dietary Intervention
no Exercise, Dietary Intervention
Exercise, Food Additive Lacking Flavonol
Wait List Control Food Additive Without Flavonol
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Richard Sloan
Columbia University Medical Center, Division of Behavioral Medicine in Psychiatry
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place