Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 14, 2012
CompletedFirst Posted
Study publicly available on registry
August 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedSeptember 29, 2022
June 1, 2013
1.5 years
August 14, 2012
September 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement in cognitive performance
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).
Assess in subjects at Baseline to week 24 using different Cognitive testing scores.
Secondary Outcomes (1)
Serum Ketones
Baselines to 6 months
Study Arms (2)
Placebo Oil
PLACEBO COMPARATORDifferential 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
EXPERIMENTALDifferential 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Are male or female with a diagnosis of Mild Cognitive Impairment
- Are 50 years of age or older
You may not qualify if:
- Been on medication for Mild Cognitive Impairment less than 90 days
- Major depression
- Uncontrolled hypothyroidism
- Known B12 deficiency
- Hepatic (liver) disease or insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2012
First Posted
August 20, 2012
Study Start
August 1, 2012
Primary Completion
February 1, 2014
Study Completion
October 1, 2014
Last Updated
September 29, 2022
Record last verified: 2013-06