Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Placebo Oil

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Medium Chain Triglyceride Oil

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No