Early Intervention in Cognitive Aging

NCT ID: NCT02751866

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2026-06-30

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 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.

Conditions

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Overweight, Obesity and Other Hyperalimentation (E65-E68)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention with carbohydrate restriction designed to produce adaptation to ketone metabolism OR intervention with berry fruit powder supplementation.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Active supplement, low carbohydrate

Whole fruit berry powder, low carbohydrate diet

Group Type ACTIVE_COMPARATOR

Berry fruit powder OR nutritional ketosis

Intervention Type DIETARY_SUPPLEMENT

Daily supplementation with berry fruit powder OR carbohydrate restriction to achieve nutritional ketosis

Placebo, Control

placebo powder, higher carbohydrate diet

Group Type PLACEBO_COMPARATOR

Placebo powder OR higher carbohydrate

Intervention Type DIETARY_SUPPLEMENT

Daily supplementation with placebo powder OR higher carbohydrate intake

Interventions

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Berry fruit powder OR nutritional ketosis

Daily supplementation with berry fruit powder OR carbohydrate restriction to achieve nutritional ketosis

Intervention Type DIETARY_SUPPLEMENT

Placebo powder OR higher carbohydrate

Daily supplementation with placebo powder OR higher carbohydrate intake

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Robert Krikorian

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Krikorian, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati Academic Health Center

Locations

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Dept of Psychiatry & Behavioral Neuroscience, UC Academic Health Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2015-1256

Identifier Type: -

Identifier Source: org_study_id

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