Mars Flavanol Exercise and Cognitive Function Study

NCT01180127 | Completed Results

• 1 other identifier: 5804
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized controlled trial to test the impact of a flavonol containing food product and aerobic exercise on cognitive function and brain structure.

Conditions

Cognitive Function

Keywords

flavonol; exercise; dentate gyrus; cerebral blood volume; dentate gyrus CBV

Outcome Measures

Primary Outcomes (2)

• CBV-fMRI (Cerebral Blood Volume-functional Magnetic Resonance Imaging)

  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

  Up to 12 weeks after exercise/dietary intervention exposure

• ModBent (Modified Benton Visual Retention Test)

  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.

  Up to 12 weeks after exercise/dietary intervention exposure

Secondary Outcomes (2)

• Modified Rey Auditory Verbal Learning Test

  Up to 12 weeks after exercise/dietary intervention exposure

• VO2max

  Up to 12 weeks after exercise/dietary intervention exposure

Study Arms (4)

exercise, dietary intervention

ACTIVE COMPARATOR

aerobic training and flavanol containing food product for 12 weeks

Dietary Supplement: Flavanol containing food product; Behavioral: Aerobic training

no exercise, dietary intervention

ACTIVE COMPARATOR

wait list control plus flavanol containing food product for 12 weeks

Dietary Supplement: Flavanol containing food product; Behavioral: Wait list control

exercise, food product lacking flavanol

ACTIVE COMPARATOR

aerobic training plus food product without flavanol for 12 weeks

Behavioral: Aerobic training; Dietary Supplement: Food product lacking flavanol

wait list control food additive without flavanol

PLACEBO COMPARATOR

wait list control plus food product without flavanol for 12 weeks

Dietary Supplement: Food product lacking flavanol; Behavioral: Wait list control

Interventions

Flavanol containing food product DIETARY_SUPPLEMENT

12 weeks, 2X/day, 20g serving

exercise, dietary intervention; no exercise, dietary intervention

Aerobic training BEHAVIORAL

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

exercise, dietary intervention; exercise, food product lacking flavanol

Food product lacking flavanol DIETARY_SUPPLEMENT

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

exercise, food product lacking flavanol; wait list control food additive without flavanol

Wait list control BEHAVIORAL

12 week wait list control condition during which participants abstain from aerobic exercise

no exercise, dietary intervention; wait list control food additive without flavanol

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Cardiac Pacemaker
• Internal Pump
• Insulin Pump
• Tattoo eyeliner
• Wire Sutures
• Internal Metal Objects
• Metal Slivers in Eye
• Prosthesis

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Mars, Inc.: collaborator

Related Publications (1)

• Pereira AC, Huddleston DE, Brickman AM, Sosunov AA, Hen R, McKhann GM, Sloan R, Gage FH, Brown TR, Small SA. An in vivo correlate of exercise-induced neurogenesis in the adult dentate gyrus. Proc Natl Acad Sci U S A. 2007 Mar 27;104(13):5638-43. doi: 10.1073/pnas.0611721104. Epub 2007 Mar 20.

  PMID: 17374720 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Richard Sloan
• Organization: Columbia University Medical Center, Division of Behavioral Medicine in Psychiatry

rps7@cumc.columbia.edu

646-774-8940

Study Officials

• Scott A Small, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: May 21, 2010
• First Posted: August 11, 2010
• Study Start: December 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 5, 2018
• Results First Posted: January 27, 2015

Record last verified: 2018-11