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OpenTrials
Completed

NCT Number: NCT01669200

Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment

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.

Completed

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medium chain triglyceride oil

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.

Placebo oil

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.

Primary outcomes

  1. Improvement in cognitive performance

    Time frame: 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 outcomes

  1. Serum Ketones

    Time frame: Baselines to 6 months

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

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 20, 2012
Registry last updated
Sep 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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