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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

May 21, 2010
March 8, 2012
December 2009
June 2013   (final data collection date for primary outcome measure)
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
CBV in the dentate gyrus [ Time Frame: change from before to after 12 weeks of the 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
Complete list of historical versions of study NCT01180127 on ClinicalTrials.gov Archive Site
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
neurocognitive function [ Time Frame: change from before to after 12 weeks of the 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
Not Provided
Not Provided
 
Mars Flavonol Exercise and Cognitive Function Study
Study of the Impact of a Flavonol Containing Food Product and Exercise on Cognitive Function and Brain Structure

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Cognitive Function
  • 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
  • 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
  • Active Comparator: exercise, dietary intervention
    aerobic training and flavonol containing food product
    Interventions:
    • Dietary Supplement: Flavonol containing food product
    • Behavioral: Aerobic training
  • Active Comparator: no exercise, dietary intervention
    wait list control plus flavonol containing food product for 12 weeks
    Interventions:
    • Dietary Supplement: Flavonol containing food product
    • Behavioral: Wait list control
  • Active Comparator: exercise, food additive lacking flavonol
    aerobic training plus food additive without flavonol
    Interventions:
    • Behavioral: Aerobic training
    • Dietary Supplement: Placebo food additive
  • 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
    Interventions:
    • Dietary Supplement: Placebo food additive
    • Behavioral: Wait list control
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. Epub 2007 Mar 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
50 Years to 75 Years
Yes
Not Provided
United States
 
NCT01180127
5804
No
New York State Psychiatric Institute
New York State Psychiatric Institute
Mars, Inc.
Principal Investigator: Scott A Small, MD Columbia University
New York State Psychiatric Institute
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP