Early Intervention in Cognitive Aging

November 27, 2023 updated by: Robert Krikorian, University of Cincinnati
Nutritional intervention in overweight middle aged individuals with subjective memory complaints.

Study Overview

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 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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Ohio
      • Cincinnati, Ohio, United States, 45267-0559
        • Dept of Psychiatry & Behavioral Neuroscience, UC Academic Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • overweight; subjective memory complaints

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active supplement, low carbohydrate
Whole fruit berry powder, low carbohydrate diet
Daily supplementation with berry fruit powder OR carbohydrate restriction to achieve nutritional ketosis
Placebo Comparator: Placebo, Control
placebo powder, higher carbohydrate diet
Daily supplementation with placebo powder OR higher carbohydrate intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin resistance
Time Frame: Eight or 12 weeks after enrollment
HOMA-IR will be derived from fasting glucose and insulin
Eight or 12 weeks after enrollment
Cognitive function
Time Frame: Eight or 12 weeks after enrollment
Performances on examiner-adminstered instruments assessing memory function
Eight or 12 weeks after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term glucose concentration
Time Frame: Eight or 12 weeks after enrollment
Glycated hemoglobin value
Eight or 12 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert Krikorian, PhD, University of Cincinnati Academic Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 21, 2016

First Submitted That Met QC Criteria

April 21, 2016

First Posted (Estimated)

April 26, 2016

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2015-1256

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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