Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Other: Placebo Oil; Other: Medium Chain Triglyceride Oil

• Registration Number: NCT01669200
• Lead Sponsor: Pennington Biomedical Research Center

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-17
• Study First Posted: 2012-08-20
• Status Verified: 2013-06
• Primary Completion: 2014-02
• Study Completion: 2014-10
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Oil	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.
Medium Chain Triglyceride Oil	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.

Primary Outcome Measures

Name	Time	Method
Improvement in cognitive performance	Assess in subjects at Baseline to week 24 using different Cognitive testing scores.	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

Name	Time	Method
Serum Ketones	Baselines to 6 months	A blood test will compare results looking for an increase of Beta-Hydroxybutyrate in the blood.

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States