Early Intervention in Cognitive Aging

Not Applicable

Active, not recruiting

• Conditions: Overweight, Obesity and Other Hyperalimentation (E65-E68)
• Interventions: Dietary Supplement: Berry fruit powder OR nutritional ketosis; Dietary Supplement: Placebo powder OR higher carbohydrate

• Registration Number: NCT02751866
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-04-21
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• overweight; subjective memory complaints

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active supplement, low carbohydrate	Berry fruit powder OR nutritional ketosis	Whole fruit berry powder, low carbohydrate diet
Placebo, Control	Placebo powder OR higher carbohydrate	placebo powder, higher carbohydrate diet

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Long term glucose concentration	Eight or 12 weeks after enrollment	Glycated hemoglobin value

Trial Locations

Locations (1)

Dept of Psychiatry & Behavioral Neuroscience, UC Academic Health Center; 🇺🇸 Cincinnati, Ohio, United States