Energy Metabolism and Cognitive Aging

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 1, 2014
Last verified: August 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 1, 2014
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
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014