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Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medium Chain Triglyceride Oil
Placebo Oil
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Oil

Medium Chain Triglyceride Oil

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Improvement in cognitive performance
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
A blood test will compare results looking for an increase of Beta-Hydroxybutyrate in the blood.

Full Information

First Posted
August 14, 2012
Last Updated
September 26, 2022
Sponsor
Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01669200
Brief Title
Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment
Official Title
Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pennington Biomedical Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Oil
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Medium Chain Triglyceride Oil
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Medium Chain Triglyceride Oil
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo Oil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in cognitive performance
Description
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).
Time Frame
Assess in subjects at Baseline to week 24 using different Cognitive testing scores.
Secondary Outcome Measure Information:
Title
Serum Ketones
Description
A blood test will compare results looking for an increase of Beta-Hydroxybutyrate in the blood.
Time Frame
Baselines to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Are male or female with a diagnosis of Mild Cognitive Impairment Are 50 years of age or older Exclusion Criteria: Been on medication for Mild Cognitive Impairment less than 90 days Major depression Uncontrolled hypothyroidism Known B12 deficiency Hepatic (liver) disease or insufficiency
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

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Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment

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