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Nutritional intervention in overweight middle aged individuals with subjective memory complaints.
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 involves intervention studies in different samples of individuals from this population to investigate the extent to which berry fruit supplementation and ketone metabolism might improve cognitive 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active supplement, low carbohydrate | Active Comparator | Whole fruit berry powder, low carbohydrate diet |
|
| Placebo, Control | Placebo Comparator | placebo powder, higher carbohydrate diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berry fruit powder OR nutritional ketosis | Dietary Supplement | Daily supplementation with berry fruit powder OR carbohydrate restriction to achieve nutritional ketosis |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Long term glucose concentration | Glycated hemoglobin value | Eight or 12 weeks after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Krikorian, PhD | University of Cincinnati Academic Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Psychiatry & Behavioral Neuroscience, UC Academic Health Center | Cincinnati | Ohio | 45267-0559 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Intervention with carbohydrate restriction designed to produce adaptation to ketone metabolism OR intervention with berry fruit powder supplementation.
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There is no blind in the dietary intervention given that participants are aware of the nature of the foods they consume. However, each dietary approach is described as healthy. In the berry supplementation studies, there is double blinding using berry fruit and placebo powders that are packaged with a code.
| Placebo powder OR higher carbohydrate | Dietary Supplement | Daily supplementation with placebo powder OR higher carbohydrate intake |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |