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N/A N=41 Randomized Single-blind Basic Science

Mars Flavanol Exercise and Cognitive Function Study

Cognitive Function

Bottom Line

View on ClinicalTrials.gov: NCT01180127 ↗
Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: CBV-fMRI (Cerebral Blood Volume-functional Magnetic Resonance Imaging) — 3.43; 2.55; 2.89; 3.38 percent CBV in a brain region — p=.0001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Flavanol containing food product (Dietary_supplement); Aerobic training (Behavioral); Food product lacking flavanol (Dietary_supplement); Wait list control (Behavioral)
Age
Adult, Older Adult · 50+ yrs
Sex
All
Sponsor
New York State Psychiatric Institute
Primary completion
Oct 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
CBV-fMRI (Cerebral Blood Volume-functional Magnetic Resonance Imaging)		 3.43; 2.55; 2.89; 3.38; 4.58; 4.48 .0001 sig
PRIMARY
ModBent (Modified Benton Visual Retention Test)		 1945; 2296; 2291; 2347; 1867; 2009 0.038 sig
SECONDARY
Modified Rey Auditory Verbal Learning Test		 0.76; 0.69; 0.80; 0.89; 0.83; 0.65 0.853
SECONDARY
VO2max		 25.6; 26.26; 25.1; 23.94; 27.8; 25.36 0.237

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.

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01180127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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