Early Intervention in Cognitive Aging

Overweight, Obesity and Other Hyperalimentation (E65-E68) Clinical Trial

Official title:

Early Intervention in Cognitive Aging

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02751866
• Other study ID #: 2015-1256
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

Inclusion Criteria:

• overweight; subjective memory complaints

Exclusion Criteria:

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Berry fruit powder OR nutritional ketosis
Daily supplementation with berry fruit powder OR carbohydrate restriction to achieve nutritional ketosis
• Placebo powder OR higher carbohydrate
Daily supplementation with placebo powder OR higher carbohydrate intake

Locations

Country	Name	City	State
United States	Dept of Psychiatry & Behavioral Neuroscience, UC Academic Health Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance	HOMA-IR will be derived from fasting glucose and insulin	Eight or 12 weeks after enrollment
Primary	Cognitive function	Performances on examiner-adminstered instruments assessing memory function	Eight or 12 weeks after enrollment
Secondary	Long term glucose concentration	Glycated hemoglobin value	Eight or 12 weeks after enrollment