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Early Intervention in Cognitive Aging

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ClinicalTrials.gov Identifier: NCT02751866
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Robert Krikorian, University of Cincinnati

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

Condition or disease Intervention/treatment Phase
Overweight, Obesity and Other Hyperalimentation (E65-E68) Dietary Supplement: Berry fruit powder OR nutritional ketosis Dietary Supplement: Placebo powder OR higher carbohydrate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention with carbohydrate restriction designed to produce adaptation to ketone metabolism OR intervention with berry fruit powder supplementation.
Masking: Double (Participant, Investigator)
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.
Primary Purpose: Prevention
Official Title: Early Intervention in Cognitive Aging
Study Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Active Comparator: Active supplement, low carbohydrate
Whole fruit berry powder, low carbohydrate diet
Dietary Supplement: Berry fruit powder OR nutritional ketosis
Daily supplementation with berry fruit powder OR carbohydrate restriction to achieve nutritional ketosis

Placebo Comparator: Placebo, Control
placebo powder, higher carbohydrate diet
Dietary Supplement: Placebo powder OR higher carbohydrate
Daily supplementation with placebo powder OR higher carbohydrate intake




Primary Outcome Measures :
  1. Insulin resistance [ Time Frame: Eight or 12 weeks after enrollment ]
    HOMA-IR will be derived from fasting glucose and insulin

  2. Cognitive function [ Time Frame: Eight or 12 weeks after enrollment ]
    Performances on examiner-adminstered instruments assessing memory function


Secondary Outcome Measures :
  1. Long term glucose concentration [ Time Frame: Eight or 12 weeks after enrollment ]
    Glycated hemoglobin value



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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • overweight; subjective memory complaints

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751866


Contacts
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Contact: Marcelle D Shidler, MA 5135582455 marcelle.shidler@uc.edu

Locations
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United States, Ohio
Dept of Psychiatry & Behavioral Neuroscience, UC Academic Health Center Recruiting
Cincinnati, Ohio, United States, 45267-0559
Contact: Marcelle Shidler, MA    513-558-2455    marcelle.shidler@uc.edu   
Sponsors and Collaborators
University of Cincinnati
Investigators
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Principal Investigator: Robert Krikorian, PhD University of Cincinnati Academic Health Center

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Responsible Party: Robert Krikorian, Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT02751866     History of Changes
Other Study ID Numbers: 2015-1256
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Overweight
Hyperphagia
Body Weight
Signs and Symptoms
Signs and Symptoms, Digestive