Early Intervention in Cognitive Aging

NCT02751866 | Active Not Recruiting

• 1 other identifier: 2015-1256
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overweight, Obesity and Other Hyperalimentation (E65-E68)

Outcome Measures

Primary Outcomes (2)

• Insulin resistance

  HOMA-IR will be derived from fasting glucose and insulin

  Eight or 12 weeks after enrollment

• Cognitive function

  Performances on examiner-adminstered instruments assessing memory function

  Eight or 12 weeks after enrollment

Secondary Outcomes (1)

• Long term glucose concentration

  Eight or 12 weeks after enrollment

Study Arms (2)

Active supplement, low carbohydrate

ACTIVE COMPARATOR

Whole fruit berry powder, low carbohydrate diet

Dietary Supplement: Berry fruit powder OR nutritional ketosis

Placebo, Control

PLACEBO COMPARATOR

placebo powder, higher carbohydrate diet

Dietary Supplement: Placebo powder OR higher carbohydrate

Interventions

Berry fruit powder OR nutritional ketosis DIETARY_SUPPLEMENT

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

Active supplement, low carbohydrate

Placebo powder OR higher carbohydrate DIETARY_SUPPLEMENT

Daily supplementation with placebo powder OR higher carbohydrate intake

Placebo, Control

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• overweight; subjective memory complaints

You may not qualify if:

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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

Dept of Psychiatry & Behavioral Neuroscience, UC Academic Health Center

Cincinnati, Ohio, 45267-0559, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Krikorian, PhD

  University of Cincinnati Academic Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Intervention with carbohydrate restriction designed to produce adaptation to ketone metabolism OR intervention with berry fruit powder supplementation.

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: April 26, 2016
• Study Start: January 1, 2016
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)