NCT02751866

Early Intervention in Cognitive Aging

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 50 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overweight, Obesity and Other Hyperalimentation (E65-E68)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Berry fruit powder OR nutritional ketosis	Daily supplementation with berry fruit powder OR carbohydrate restriction to achieve nutritional ketosis
DIETARY_SUPPLEMENT	Placebo powder OR higher carbohydrate	Daily supplementation with placebo powder OR higher carbohydrate intake

Timeline

• Start date: 2016-01-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2016-04-26
• Last updated: 2025-04-01

Locations

1 site across 1 country: United States