Early Intervention in Cognitive Aging

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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

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

Trial contacts and locations

1

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Central trial contact

Marcelle D Shidler, MA

Data sourced from clinicaltrials.gov

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