Energy Metabolism and Cognitive Aging

NCT00777010 | Completed

• 1 other identifier: 04-09-17-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Participants 60 and older with and without Parkinson's disease who have mild cognitive decline will be randomized to either a standard higher carbohydrate diet or a carbohydrate-restricted ketogenic diet for 8 weeks. The main hypothesis is that nutritional ketosis will 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.

Conditions

Mild Cognitive Impairment

Keywords

memory loss; mild cognitive impairment; forgetfulness

Outcome Measures

Primary Outcomes (1)

• improvement in memory testing

  6 or 8 weeks

Secondary Outcomes (1)

• correlation between diet, metabolic factors, memory performance, and cerebral activation

  6 or 8 weeks

Study Arms (2)

Healthy high carbohydrate diet

ACTIVE COMPARATOR

Participants will follow a typical, higher carbohydrate dietary intervention with emphasis on lower glycemic carbohydrate foods and monounsaturated fatty acid consumption

Other: Healthy high carbohydrate diet

Carbohydrate restricted, ketogenic diet

EXPERIMENTAL

Paricipants will follow a carbohydrate restricted dietary intervention designed to induce ketone metabolism

Other: Ketogenic diet

Interventions

Ketogenic diet OTHER

carbohydrate restricted diet

Carbohydrate restricted, ketogenic diet

Healthy high carbohydrate diet OTHER

higher carbohydrate diet

Healthy high carbohydrate diet

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 years or older
• Mild cognitive impairment

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Memory Disorders

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Robert Krikorian, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel groups, randomized controlled nutritional intervention.

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 22, 2008
• Study Start: September 1, 2008
• Primary Completion: December 31, 2016
• Study Completion: March 15, 2017
• Last Updated: March 24, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)