search
Back to results

Early Intervention in Cognitive Aging

Primary Purpose

Overweight, Obesity and Other Hyperalimentation (E65-E68)

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Berry fruit powder OR nutritional ketosis
Placebo powder OR higher carbohydrate
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight, Obesity and Other Hyperalimentation (E65-E68)

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • overweight; subjective memory complaints

Exclusion Criteria:

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

Sites / Locations

  • Dept of Psychiatry & Behavioral Neuroscience, UC Academic Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active supplement, low carbohydrate

Placebo, Control

Arm Description

Whole fruit berry powder, low carbohydrate diet

placebo powder, higher carbohydrate diet

Outcomes

Primary Outcome Measures

Insulin resistance
HOMA-IR will be derived from fasting glucose and insulin
Cognitive function
Performances on examiner-adminstered instruments assessing memory function

Secondary Outcome Measures

Long term glucose concentration
Glycated hemoglobin value

Full Information

First Posted
April 21, 2016
Last Updated
September 8, 2023
Sponsor
University of Cincinnati
search

1. Study Identification

Unique Protocol Identification Number
NCT02751866
Brief Title
Early Intervention in Cognitive Aging
Official Title
Early Intervention in Cognitive Aging
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity and Other Hyperalimentation (E65-E68)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention with carbohydrate restriction designed to produce adaptation to ketone metabolism OR intervention with berry fruit powder supplementation.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active supplement, low carbohydrate
Arm Type
Active Comparator
Arm Description
Whole fruit berry powder, low carbohydrate diet
Arm Title
Placebo, Control
Arm Type
Placebo Comparator
Arm Description
placebo powder, higher carbohydrate diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Berry fruit powder OR nutritional ketosis
Intervention Description
Daily supplementation with berry fruit powder OR carbohydrate restriction to achieve nutritional ketosis
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo powder OR higher carbohydrate
Intervention Description
Daily supplementation with placebo powder OR higher carbohydrate intake
Primary Outcome Measure Information:
Title
Insulin resistance
Description
HOMA-IR will be derived from fasting glucose and insulin
Time Frame
Eight or 12 weeks after enrollment
Title
Cognitive function
Description
Performances on examiner-adminstered instruments assessing memory function
Time Frame
Eight or 12 weeks after enrollment
Secondary Outcome Measure Information:
Title
Long term glucose concentration
Description
Glycated hemoglobin value
Time Frame
Eight or 12 weeks after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: overweight; subjective memory complaints Exclusion Criteria: diabetes; liver or kidney disease; age-related memory disorder; neurologic or psychiatric condition; substance abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Krikorian, PhD
Organizational Affiliation
University of Cincinnati Academic Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Psychiatry & Behavioral Neuroscience, UC Academic Health Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0559
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Early Intervention in Cognitive Aging

We'll reach out to this number within 24 hrs