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Mars Flavanol Exercise and Cognitive Function Study

N

New York State Psychiatric Institute

Status

Completed

Conditions

Cognitive Function

Treatments

Dietary Supplement: Food product lacking flavanol
Dietary Supplement: Flavanol containing food product
Behavioral: Wait list control
Behavioral: Aerobic training

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Full 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 ability. A range of studies have established that memory is a cognitive domain differentially targeted by the normal aging process. With an increase in lifespan and a decrease in co-morbid diseases, aging individuals expect to lead cognitively-challenging lives. Even mild forgetfulness, therefore, is no longer considered 'benign'. Indeed, with the exponential growth of the aging population, and since memory decline will occur in all of us as we age, age-related memory decline has emerged as a major societal problem.

B. The anatomy of cognitive aging. A range of studies in humans, non-human primates and rodents have established that the hippocampal formation, a brain circuit vital for memory, is targeted by the aging process. Age-related hippocampal dysfunction is therefore a major contributor to age-related memory decline.

The hippocampal formation is organized as a circuit, made up of separate but interconnected regions, including the entorhinal cortex, the dentate gyrus, the CA subfields, and the subiculum. Because of hippocampal circuit properties, dysfunction in one subregion will affect the function of neighboring subregions and the hippocampal circuit as a whole. Thus, when confronted with any process that causes the hippocampal circuit to malfunction, pinpointing the subregion that is most effected becomes an important goal.

In the case of age-related memory decline, a range of studies in humans, non-human primates, and rodents, have suggested that normal aging causes hippocampal dysfunction by differentially targeting the dentate gyrus.

C. Imaging cognitive aging. The anatomical organization of the hippocampal circuit and the differential vulnerability of the dentate gyrus to cognitive aging imposes specific requirements on brain imaging techniques. Specifically, an imaging technique must be able to assess the functional integrity of the multiple hippocampal subregions, in particular the dentate gyrus. With this in mind, our lab has been dedicated to optimizing a functional brain imaging approach applicable to both the human and rodent hippocampal formation. We have recently achieved this goal, and have been applying our cross-species imaging capabilities to investigate a range of process that affect hippocampal function.

D. Flavanols, exercise, and cognitive aging. Previous studies have established that physical exercise improved hippocampal function. We have recently exploited our cross-species imaging techniques to show, that within the hippocampal circuit, exercise has a selective effect on dentate gyrus function, in humans and in mice. Independently, a recent study has shown that the flavanol epichatechin improves hippocampal function, and importantly, within the hippocampal circuit, epichatechin was found to differentially target the dentate gyrus. Moreover, this study showed that epichatechin coupled with exercise had its greatest effect on dentate gyrus function.

E. Summary. Starting at around 30 years of age, all of us will begin experiencing the insidious cognitive slide of age-related memory decline. With the expansion of aging, age-related memory decline is swelling to epidemic proportions, and ameliorating age-related memory decline has emerged as major societal goal.

This proposal is designed to test the following hypothesis: That flavanols with or without physical exercise will ameliorate age-related memory decline. This hypothesis is informed by two sets of interleaving findings: First, a range of studies have pinpointed dysfunction in the dentate gyrus as a specific brain region contributing to age-related memory decline; and second, flavanol consumption with or without physical exercise enhances memory performance by improving dentate gyrus function.

In order to experimentally test this hypothesis an imaging technique is required that can assess the functional integrity of the dentate gyrus, techniques that are now available. Importantly, these imaging techniques have been developed so that can they can be applied not only to humans but also to animal models, generating the same 'imaging readout'. Cross-species imaging is particularly important for translational studies.

Enrollment

41 patients

Sex

All

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

41 participants in 4 patient groups, including a placebo group

exercise, dietary intervention
Active Comparator group
Description:
aerobic training and flavanol containing food product for 12 weeks
Treatment:
Behavioral: Aerobic training
Dietary Supplement: Flavanol containing food product
no exercise, dietary intervention
Active Comparator group
Description:
wait list control plus flavanol containing food product for 12 weeks
Treatment:
Dietary Supplement: Flavanol containing food product
Behavioral: Wait list control
exercise, food product lacking flavanol
Active Comparator group
Description:
aerobic training plus food product without flavanol for 12 weeks
Treatment:
Behavioral: Aerobic training
Dietary Supplement: Food product lacking flavanol
wait list control food additive without flavanol
Placebo Comparator group
Description:
wait list control plus food product without flavanol for 12 weeks
Treatment:
Dietary Supplement: Food product lacking flavanol
Behavioral: Wait list control

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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