- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02751866
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
Status
Active, not recruiting
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
- Name: Marcelle D Shidler, MA
- Phone Number: 5135582455
- Email: marcelle.shidler@uc.edu
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.
Sponsor
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
Additional Relevant MeSH Terms
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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