Early Intervention in Cognitive Aging

Study Overview
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Brief Summary
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Nutritional intervention in overweight middle aged individuals with subjective memory complaints.

Detailed Description
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Late-onset AD develops over many years during a preclinical period in which neuropathological changes accumulate before dementia is evident. Deposition of amyloid-beta (Aβ) in the brain is the earliest recognized biomarker of AD pathology, and, demographically, Aβ accumulation begins to accelerate at age 50, a period when the incidence of metabolic disturbance increases as well. Hyperinsulinemia associated with insulin receptor resistance has been associated with AD pathololgy, and metabolic disturbance in mid-life increases risk for subsequent dementia. There are indications that subjective memory complaints can be an early indicator of developing neuropathology and may be the first manifestation of future dementia. This research involve intervention studies in different samples of individuals from this population to investigate the extent to which berry fruit supplementation and ketone metabolism might improve memory performance in association with enhancement of metabolic function and related factors. The ultimate goal of this research is to develop interventional approaches that might be applied with at-risk individuals in the preclinical period of dementia to forestall or prevent progression of neurocognitive decline.

Official Title
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Early Intervention in Cognitive Aging

Conditions
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Overweight, Obesity and Other Hyperalimentation (E65-E68)

Intervention / Treatment
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* Dietary Supplement: Berry fruit powder OR nutritional ketosis
* Dietary Supplement: Placebo powder OR higher carbohydrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: overweight; subjective memory complaints Exclusion Criteria: diabetes; liver or kidney disease; age-related memory disorder; neurologic or psychiatric condition; substance abuse

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention with carbohydrate restriction designed to produce adaptation to ketone metabolism OR intervention with berry fruit powder supplementation.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active supplement, low carbohydrate<br>Whole fruit berry powder, low carbohydrate diet | Dietary Supplement: Berry fruit powder OR nutritional ketosis<br>* Daily supplementation with berry fruit powder OR carbohydrate restriction to achieve nutritional ketosis<br>|
| Placebo Comparator: Placebo, Control<br>placebo powder, higher carbohydrate diet | Dietary Supplement: Placebo powder OR higher carbohydrate<br>* Daily supplementation with placebo powder OR higher carbohydrate intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance | HOMA-IR will be derived from fasting glucose and insulin | Eight or 12 weeks after enrollment | 
| Cognitive function | Performances on examiner-adminstered instruments assessing memory function | Eight or 12 weeks after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term glucose concentration | Glycated hemoglobin value | Eight or 12 weeks after enrollment |