Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02751866

Early Intervention in Cognitive Aging

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Overweight, Obesity and Other Hyperalimentation (E65-E68) Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Psychiatry & Behavioral Neuroscience, UC Academic Health Center

Cincinnati, Ohio, 45267-0559, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • overweight; subjective memory complaints

Exclusion criteria

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

Treatment and study plan

Berry fruit powder OR nutritional ketosis

Dietary Supplement

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

Placebo powder OR higher carbohydrate

Dietary Supplement

Daily supplementation with placebo powder OR higher carbohydrate intake

Primary outcomes

  1. Insulin resistance

    Time frame: Eight or 12 weeks after enrollment

    HOMA-IR will be derived from fasting glucose and insulin

  2. Cognitive function

    Time frame: Eight or 12 weeks after enrollment

    Performances on examiner-adminstered instruments assessing memory function

Secondary outcomes

  1. Long term glucose concentration

    Time frame: Eight or 12 weeks after enrollment

    Glycated hemoglobin value

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Apr 26, 2016
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.