Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment

Pennington Biomedical Research Center

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Other: Medium Chain Triglyceride Oil; Other: Placebo Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT01669200

PBRC 12024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4 participants in 2 patient groups, including a placebo group

Placebo Oil

Placebo Comparator group

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.

Treatment:

Other: Placebo Oil

Medium Chain Triglyceride Oil

Experimental group

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.

Treatment:

Other: Medium Chain Triglyceride Oil