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Mars Flavonol Exercise and Cognitive Function Study

This study is currently recruiting participants.
Verified March 2012 by New York State Psychiatric Institute
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: March 8, 2012
Last verified: March 2012
History of Changes
  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: Flavonol containing food product
Behavioral: Aerobic training
Dietary Supplement: Placebo food additive
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 Flavonol Containing Food Product and Exercise on Cognitive Function and Brain Structure

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • CBV in the dentate gyrus [ Time Frame: Up to 12 weeks after exercise/dietary intervention exposure ] [ Designated as safety issue: No ]
    CBV will be measured at randomization, i.e., before exposure to the intervention, and then again after completion of the 12-week intervention


Secondary Outcome Measures:
  • neurocognitive function [ 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


Estimated Enrollment: 80
Study Start Date: December 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: exercise, dietary intervention
aerobic training and flavonol containing food product
 Dietary Supplement: Flavonol containing food product
12 weeks, 2X/day, 20g serving
Other Names:
  • Aerobic training
  • Placebo food additive
  • Wait list control
Behavioral: Aerobic training
4X/week, 1 hour/session at 75% maximum HR
Other Names:
  • Flavonol containing food products
  • Placebo food additive
  • Wait list control
Active Comparator: no exercise, dietary intervention
wait list control plus flavonol containing food product for 12 weeks
 Dietary Supplement: Flavonol containing food product
12 weeks, 2X/day, 20g serving
Other Names:
  • Aerobic training
  • Placebo food additive
  • Wait list control
Behavioral: Wait list control
12 week wait list control condition during which participant abstain from aerobic exercise
Other Names:
  • Flavonol containing food product
  • Aerobic training
  • Placebo food additive
Active Comparator: exercise, food additive lacking flavonol
aerobic training plus food additive without flavonol
 Behavioral: Aerobic training
4X/week, 1 hour/session at 75% maximum HR
Other Names:
  • Flavonol containing food products
  • Placebo food additive
  • Wait list control
Dietary Supplement: Placebo food additive
20 g serving, 2X/day, food additive lacking flavonol
Other Names:
  • Flavonol containing food product
  • Aerobic training
  • Wait list control
Placebo Comparator: wait list control food additive without flavonol
12 weeks of wait list control status plus food additive without the flavonol containing food product
 Dietary Supplement: Placebo food additive
20 g serving, 2X/day, food additive lacking flavonol
Other Names:
  • Flavonol containing food product
  • Aerobic training
  • Wait list control
Behavioral: Wait list control
12 week wait list control condition during which participant abstain from aerobic exercise
Other Names:
  • Flavonol containing food product
  • Aerobic training
  • Placebo food additive

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

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Scott A Small, MD     212-305-1269     sas68@columbia.edu    
Contact: Richard P Sloan, PhD     212-851-5575     rps7@columbia.edu    
Sub-Investigator: Richard P Sloan, PhD            
Sub-Investigator: Adam Brickman, PhD            
Sub-Investigator: Iris Asllani, PhD            
Sub-Investigator: Paula S McKinley, PhD            
Sub-Investigator: Arlene King, PhD            
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
Last Updated: March 8, 2012
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 19, 2013