Energy Metabolism and Cognitive Aging

This study is currently recruiting participants.
Verified December 2013 by University of Cincinnati
Sponsor:
Information provided by (Responsible Party):
Robert Krikorian, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00777010
First received: October 21, 2008
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

Participants 60 and older with and without Parkinson's disease who have mild cognitive decline will be randomized to either a healthy, high carbohydrate diet or an Atkins low-carbohydrate diet for approximately 6 or 8 weeks with the hypothesis that the low-carbohydrate diet may improve memory functioning. Pre and post-memory testing will be performed. Subjects will also provide blood samples and a subset of subjects with receive magnetic resonance brain imaging.


Condition Intervention Phase
Mild Cognitive Impairment
Other: Atkins low carbohydrate diet
Behavioral: Healthy high carbohydrate diet
Behavioral: Atkins low carbohydrate diet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Energy Metabolism and Cognitive Aging

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • improvement in memory testing [ Time Frame: 6 or 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • correlation between diet, metabolic factors, memory performance, and cerebral activation [ Time Frame: 6 or 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy high carbohydrate diet
Healthy high carbohydrate diet
Behavioral: Healthy high carbohydrate diet
The healthy high carbohydrate diet consisted of high carbohydrate (50% of daily calories). The high carbohydrate subjects were advised to consume fruits and vegetables as carbohydrate sources as much as possible.
Other Names:
  • Healthy carbohydrates
  • Fruits
  • Vegetables
Active Comparator: Atkins low carbohydrate diet
Atkins low carbohydrate diet
Other: Atkins low carbohydrate diet
Atkins low carbohydrate diet compared to a healthy, high carbohydrate diet
Other Name: Atkins low carbohydrate diet
Behavioral: Atkins low carbohydrate diet
Those on the low carbohydrate diet were advised to consume no more than 20 g carbohydrate per day and were restricted from fruit and instructed to limit carbohydrate consumption to small portions of vegetables.
Other Names:
  • Small portions of vegetables
  • No fruit

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 60 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@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@uc.edu   
Contact: Robert Krikorian, PhD    513-558-4218    robert.krikorian@uc.edu   
Principal Investigator: Robert Krikorian, PhD         
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Robert Krikorian, PhD University of Cincinnati
  More Information

No publications provided

Responsible Party: Robert Krikorian, Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00777010     History of Changes
Other Study ID Numbers: 04-09-17-01
Study First Received: October 21, 2008
Last Updated: December 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
memory loss
mild cognitive impairment
forgetfulness

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014