Early Intervention in Cognitive Aging

University of Cincinnati

Status: Active, not recruiting

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

Treatments: Dietary Supplement: Berry fruit powder OR nutritional ketosis; Dietary Supplement: Placebo powder OR higher carbohydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02751866

2015-1256

Details and patient eligibility

About

Nutritional intervention in overweight middle aged individuals with subjective memory complaints.

Full 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 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• overweight; subjective memory complaints

Exclusion criteria

• diabetes; liver or kidney disease; age-related memory disorder; neurologic or psychiatric condition; substance abuse

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups, including a placebo group

Active supplement, low carbohydrate

Active Comparator group

Description:

Whole fruit berry powder, low carbohydrate diet

Treatment:

Dietary Supplement: Berry fruit powder OR nutritional ketosis

Placebo, Control

Placebo Comparator group

Description:

placebo powder, higher carbohydrate diet

Treatment:

Dietary Supplement: Placebo powder OR higher carbohydrate