Overweight, Obesity and Other Hyperalimentation (E65-E68)
Conditions
Brief summary
Nutritional intervention in overweight middle aged individuals with subjective memory complaints.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTBerry fruit powder OR nutritional ketosis
Daily supplementation with berry fruit powder OR carbohydrate restriction to achieve nutritional ketosis
DIETARY_SUPPLEMENTPlacebo powder OR higher carbohydrate
Daily supplementation with placebo powder OR higher carbohydrate intake
Sponsors
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
Intervention with carbohydrate restriction designed to produce adaptation to ketone metabolism OR intervention with berry fruit powder supplementation.
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* overweight; subjective memory complaints
Exclusion criteria
* diabetes; liver or kidney disease; age-related memory disorder; neurologic or psychiatric condition; substance abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin resistance | Eight or 12 weeks after enrollment | HOMA-IR will be derived from fasting glucose and insulin |
| Cognitive function | Eight or 12 weeks after enrollment | Performances on examiner-adminstered instruments assessing memory function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long term glucose concentration | Eight or 12 weeks after enrollment | Glycated hemoglobin value |
Countries
United States
Outcome results
None listed