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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cognitive Function | Dietary Supplement: Flavanol containing food product Behavioral: Aerobic training Dietary Supplement: Food product lacking flavanol Behavioral: Wait list control | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 41 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Basic Science |
Official Title: | Study of the Impact of a Flavanol Containing Food Product and Exercise on Cognitive Function and Brain Structure |
Study Start Date : | December 2009 |
Actual Primary Completion Date : | October 2013 |
Actual Study Completion Date : | October 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: exercise, dietary intervention
aerobic training and flavanol containing food product for 12 weeks
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Dietary Supplement: Flavanol containing food product
12 weeks, 2X/day, 20g serving Behavioral: Aerobic training 4X/week, 1 hour/session at 75% maximum HR |
Active Comparator: no exercise, dietary intervention
wait list control plus flavanol containing food product for 12 weeks
|
Dietary Supplement: Flavanol containing food product
12 weeks, 2X/day, 20g serving Behavioral: Wait list control 12 week wait list control condition during which participants abstain from aerobic exercise |
Active Comparator: exercise, food product lacking flavanol
aerobic training plus food product without flavanol for 12 weeks
|
Behavioral: Aerobic training
4X/week, 1 hour/session at 75% maximum HR Dietary Supplement: Food product lacking flavanol 20 g serving, 2X/day, food additive lacking flavonol |
Placebo Comparator: wait list control food additive without flavanol
wait list control plus food product without flavanol for 12 weeks
|
Dietary Supplement: Food product lacking flavanol
20 g serving, 2X/day, food additive lacking flavonol Behavioral: Wait list control 12 week wait list control condition during which participants abstain from aerobic exercise |
- CBV-fMRI (Cerebral Blood Volume-functional Magnetic Resonance Imaging) [ Time Frame: Up to 12 weeks after exercise/dietary intervention exposure ]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
- ModBent (Modified Benton Visual Retention Test) [ Time Frame: Up to 12 weeks after exercise/dietary intervention exposure ]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.
- Modified Rey Auditory Verbal Learning Test [ Time Frame: Up to 12 weeks after exercise/dietary intervention exposure ]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.
- VO2max [ Time Frame: Up to 12 weeks after exercise/dietary intervention exposure ]measured at randomization, i.e., before exposure to the intervention, and then again after completion of the 12-week intervention

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Ages Eligible for Study: | 50 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 50-75
- English-speaking
- Ambulatory
- BMI < 32
- Post-menopausal (women only), no estrogen replacement therapy
- VO2max < 36 and 33 ml/kg/min for men age 50-59 and 60-69 respectively; < 29 and 27 ml/kg/min for women age 50-59 and 60-75 respectively.
- Baecke Physical Activity Sports Score ≤ 2
- Medical clearance to participate in the study (normal serum electrolyte, BUN, creatinine levels, normal blood pressure and resting cardiogram)
Exclusion Criteria:
- Use of psychotropic medications
- Current psychiatric disorder
- Any condition for which aerobic training is counter-indicated
- Habitual consumers of dietary or herbal supplements, including Gingko, flavonoid, and dietary herbal or plant extracts
- Lactose Intolerance
- Individuals who report directly to any of the study investigators
- Diabetes
Exclusion Criteria (MRI-related)
- Cardiac Pacemaker
- Internal Pump
- Insulin Pump
- Tattoo eyeliner
- Wire Sutures
- Internal Metal Objects
- Metal Slivers in Eye
- Prosthesis
- Hearing Aid Implants
- Neurostimulator
- Metal Fragments
- Brain Aneurysm Clips
- Vascular Clips
- Breast Expander
- Vena Cava Filter
- Heart Valve
- Metal Stents
- Asthma
- Hay-Fever
- Sickle Cell Disease
- Kidney Disease
- Pregnant

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180127
Principal Investigator: | Scott A Small, MD | Columbia University |
Responsible Party: | Richard Sloan, Research Scientist, New York State Psychiatric Institute |
ClinicalTrials.gov Identifier: | NCT01180127 |
Other Study ID Numbers: |
5804 |
First Posted: | August 11, 2010 Key Record Dates |
Results First Posted: | January 27, 2015 |
Last Update Posted: | December 5, 2018 |
Last Verified: | November 2018 |
flavonol exercise dentate gyrus cerebral blood volume dentate gyrus CBV |