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Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Pennington Biomedical Research Center
Sponsor:
Information provided by (Responsible Party):
Jeffrey Keller, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01669200
First received: August 14, 2012
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

The primary aim of this study is to assess whether daily dosing with medium chain triglycerides in subjects with mild cognitive impairment (MCI) will improve cognitive performance.


Condition Intervention
Mild Cognitive Impairment
Other: Medium Chain Triglyceride Oil
Other: Placebo Oil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Improvement in cognitive performance [ Time Frame: Assess in subjects at Baseline to week 24 using different Cognitive testing scores. ] [ Designated as safety issue: No ]
    Daily dosing of in subjects with Medium Chain Triglyceride Oil will change cognition scores measured at baseline to the end of week 24 using cognitive testing results. (ADAS-Cog, Trails Making Test, Mini Mental State Exam, Digit Symbol Test and Short-Form 36 Health Survey).


Secondary Outcome Measures:
  • Serum Ketones [ Time Frame: Baselines to 6 months ] [ Designated as safety issue: No ]
    A blood test will compare results looking for an increase of Beta-Hydroxybutyrate in the blood.


Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Oil
Differential changes will be compared in the test group versus the control group at one month and six months with respect to BHB and insulin levels, and at six months with respect to cognitive scores.
Other: Placebo Oil
Differential changes will be compared in the control group at one month and six months with respect to serum Beta-Hydroxybutyrate and insulin levels, and at six months with respect to cognitive scores.
Experimental: Medium Chain Triglyceride Oil
Differential changes will be compared in the test group versus the control group at one month and six months with respect to BHB and insulin levels, and at six months with respect to cognitive scores.
Other: Medium Chain Triglyceride Oil
Differential changes will be compared in the test group at one month and six months with respect to serum Beta-Hydroxybutyrate and insulin levels, and at six months with respect to cognitive scores.

Detailed Description:

Twenty eligible subjects will be enrolled in the study that will consist of a baseline visit followed by six post-baseline visits. The control and placebo groups will each be comprised of ten subjects randomly assigned to the groups. The assessments at baseline will include concomitant medications, vital signs, height, and weight. In addition, subjects will complete a medical history questionnaire, and receive group instruction on incorporation of the study products into the diet from a registered dietitian. Study products will be dispensed at each visit in excess of requirements, and re-issued at every visit after measurement of the remaining product that subjects will be instructed to bring to every visit. The post-baseline study visits will include body weight and vital sign measurements, concomitant medications, dispensation of study products, group instruction by a registered dietitian, and an assessment for adverse events.

Between study visits the subjects will receive a telephone call from the study coordinator to encourage compliance with the diet, and to ask about any adverse events. The study visits will conclude at week 24. The psychological tests conducted by clinicians at screening will be repeated during the cognitive testing visit.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Are male or female with a diagnosis of Mild Cognitive Impairment
  2. Are 50 years of age or older

Exclusion Criteria:

  1. Been on medication for Mild Cognitive Impairment less than 90 days
  2. Major depression
  3. Uncontrolled hypothyroidism
  4. Known B12 deficiency
  5. Hepatic (liver) disease or insufficiency
  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: NCT01669200

Locations
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: recruiters    225-763-3000    recruiters@pbrc.edu   
Principal Investigator: Jeffrey Keller, PhD         
Sub-Investigator: Frank Greenway, MD         
Sub-Investigator: Ann Liu, PhD         
Sub-Investigator: Candida Rebello, RD         
Sponsors and Collaborators
Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: Jeffrey Keller, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01669200     History of Changes
Other Study ID Numbers: PBRC12024
Study First Received: August 14, 2012
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014