Energy Metabolism and Cognitive Aging

This study is currently recruiting participants. (see Contacts and Locations)

Verified December 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: December 22, 2014

Last verified: December 2014

History of Changes

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:

MedlinePlus related topics: Memory Mild Cognitive Impairment

U.S. FDA Resources

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

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:	December 22, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Cincinnati:


memory loss mild cognitive impairment forgetfulness

Additional relevant MeSH terms:


Mild Cognitive Impairment Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders

ClinicalTrials.gov processed this record on March 03, 2015

To Top