Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Mild Cognitive Impairment |
Other: Medium Chain Triglyceride Oil Other: Placebo Oil |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment |
- Improvement in cognitive performance [ Time Frame: Assess in subjects at Baseline to week 24 using different Cognitive testing scores. ] [ Designated as safety issue: No ]Daily dosing of in subjects with Medium Chain Triglyceride Oil will change cognition scores measured at baseline to the end of week 24 using cognative testing results. (ADAS-Cog, Trails Making Test, Mini Mental State Exam, Digit Symbol Test and Short-Form 36 Health Survey).
- Serum Ketones [ Time Frame: Baselines to 6 months ] [ Designated as safety issue: No ]A blood test will compare results looking for an increase of Beta-Hydroxybutyrate in the blood.
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 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.
|
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.
|
|
Experimental: 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.
|
Other: 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.
|
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Louisiana | |
| Pennington Biomedical Research Center | Recruiting |
| Baton Rouge, Louisiana, United States, 70808 | |
| Contact: recruiters 225-763-3000 recruiters@pbrc.edu | |
| Principal Investigator: Jeffrey Keller, PhD | |
| Sub-Investigator: Frank Greenway, MD | |
| Sub-Investigator: Ann Liu, PhD | |
| Sub-Investigator: Candida Rebello, RD | |
More Information
No publications provided
| Responsible Party: | Jeffrey Keller, Principal Investigator, Pennington Biomedical Research Center |
| ClinicalTrials.gov Identifier: | NCT01669200 History of Changes |
| Other Study ID Numbers: | PBRC12024 |
| Study First Received: | August 14, 2012 |
| Last Updated: | August 17, 2012 |
| Health Authority: | USA: Institutional Review Board |
Additional relevant MeSH terms:
|
Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013