Mars Flavanol Exercise and Cognitive Function Study

This study has been completed.
Sponsor:
Collaborator:
Mars, Inc.
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01180127
First received: May 21, 2010
Last updated: January 14, 2015
Last verified: December 2014
  Purpose

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.


Condition Intervention Phase
Cognitive Function
Dietary Supplement: Flavanol containing food product
Behavioral: Aerobic training
Dietary Supplement: Food product lacking flavanol
Behavioral: Wait list control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • CBV-fMRI (Cerebral Blood Volume-functional Magnetic Resonance Imaging) [ Time Frame: Up to 12 weeks after exercise/dietary intervention exposure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Modified Rey Auditory Verbal Learning Test [ Time Frame: Up to 12 weeks after exercise/dietary intervention exposure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    measured at randomization, i.e., before exposure to the intervention, and then again after completion of the 12-week intervention


Enrollment: 41
Study Start Date: December 2009
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: exercise, dietary intervention
aerobic training and flavanol containing food product for 12 weeks
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 50-75
  2. English-speaking
  3. Ambulatory
  4. BMI < 32
  5. Post-menopausal (women only), no estrogen replacement therapy
  6. 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.
  7. Baecke Physical Activity Sports Score ≤ 2
  8. Medical clearance to participate in the study (normal serum electrolyte, BUN, creatinine levels, normal blood pressure and resting cardiogram)

Exclusion Criteria:

  1. Use of psychotropic medications
  2. Current psychiatric disorder
  3. Any condition for which aerobic training is counter-indicated
  4. Habitual consumers of dietary or herbal supplements, including Gingko, flavonoid, and dietary herbal or plant extracts
  5. Lactose Intolerance
  6. Individuals who report directly to any of the study investigators
  7. Diabetes

Exclusion Criteria (MRI-related)

  1. Cardiac Pacemaker
  2. Internal Pump
  3. Insulin Pump
  4. Tattoo eyeliner
  5. Wire Sutures
  6. Internal Metal Objects
  7. Metal Slivers in Eye
  8. Prosthesis
  9. Hearing Aid Implants
  10. Neurostimulator
  11. Metal Fragments
  12. Brain Aneurysm Clips
  13. Vascular Clips
  14. Breast Expander
  15. Vena Cava Filter
  16. Heart Valve
  17. Metal Stents
  18. Asthma
  19. Hay-Fever
  20. Sickle Cell Disease
  21. Kidney Disease
  22. Pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180127

Sponsors and Collaborators
New York State Psychiatric Institute
Mars, Inc.
Investigators
Principal Investigator: Scott A Small, MD Columbia University
  More Information

Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01180127     History of Changes
Other Study ID Numbers: 5804
Study First Received: May 21, 2010
Results First Received: December 23, 2014
Last Updated: January 14, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
flavonol
exercise
dentate gyrus
cerebral blood volume
dentate gyrus CBV

ClinicalTrials.gov processed this record on May 29, 2015