Energy Metabolism and Cognitive Aging - Full Text View

Sponsors and Collaborators:	University of Cincinnati Robert C. Atkins Foundation
Information provided by:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00777010

Purpose

Participants 66 and older who have mild cognitive decline will be randomized to either a healthy, high carbohydrate diet or an Atkins low-carbohydrate diet for approximately 6 weeks with the hypothesis that the low-carbohydrate diet may improve memory functioning. Pre and post-memory testing will be performed, subjects will also receive a blood draw and fMRI scan of the brain.

Condition	Intervention	Phase
Mild Cognitive Impairment	Other: Atkins low carbohydrate diet	Phase IV

MedlinePlus related topics: Memory

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Energy Metabolism and Cognitive Aging

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:

improvement in memory testing [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

correlation between salivary cortisol levels and diet, blood sugar levels, inflammation and diet, increase in brain activity (measured by fMRI) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Healthy high carbohydrate diet	Other: Atkins low carbohydrate diet Atkins low carbohydrate diet compared to a healthy, high carbohydrate diet
2: Active Comparator Atkins low carbohydrate diet	Other: Atkins low carbohydrate diet Atkins low carbohydrate diet compared to a healthy, high carbohydrate diet

Eligibility

Ages Eligible for Study:	66 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 66 years or older
Mild cognitive impairment

Exclusion Criteria:

Diabetes
Medications that have effect on memory
Memory problems due to medical issues (ie head injury, stroke, untreated sleep apnea etc.)
Unable to complete an MRI scan

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777010

Contacts

Contact: Marcelle Shidler, MA	513-558-2455	marcelle.shidler@psychiatry.uc.edu
Contact: Robert Krikorian, PhD	513-558-4218	robert.krikorian@uc.edu

Locations

United States, Ohio
University of Cincinnati	Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Marcelle Shidler 513-558-2455 marcelle.shidler@psychiatry.uc.edu
Contact: Robert Krikorian, PhD 513-558-4218 robert.krikorian@uc.edu
Principal Investigator: Robert Krikorian, PhD

Sponsors and Collaborators

University of Cincinnati

Robert C. Atkins Foundation

Investigators

Principal Investigator:

Robert Krikorian, PhD

University of Cincinnati

More Information

Responsible Party:	University of Cincinnati ( Robert Krikorian, PhD )
Study ID Numbers:	04-09-17-01
Study First Received:	October 21, 2008
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00777010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Cincinnati:

memory loss
mild cognitive impairment
forgetfulness

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia

Cognition Disorders
Amnesia
Delirium

ClinicalTrials.gov processed this record on January 16, 2009