Status:
COMPLETED
Mars Flavanol Exercise and Cognitive Function Study
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
Mars, Inc.
Conditions:
Cognitive Function
Eligibility:
All Genders
50-75 years
Phase:
NA
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.
Detailed Description
I. Background and Significance A. The epidemiology of cognitive aging. Encompassing multiple cognitive domains, higher order thinking includes memory, language, abstract reasoning, and visuospatial ab...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01180127
Start Date
December 1 2009
End Date
October 1 2013
Last Update
December 5 2018
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