Background/Rationale: Cognitive problems are a common symptom in individuals with Multiple Sclerosis (MS). Treatment options are limited, and there is a pressing need for new interventions to treat MS-related cognitive impairment. Glucose (a type of sugar) is used to fuel the cells of the healthy brain. For people with neurological conditions such as MS, glucose is not converted into energy as efficiently as it would be in a healthy brain, which can lead to a decrease in cognitive function. Caprylic Triglyceride may work to bypass this problem by providing an alternative energy source that is metabolized in the liver and used by the brain. Objective: To evaluate the therapeutic effects of 90 days of caprylic triglyceride on cognitive impairment in multiple sclerosis. Design: Randomized, double blinded, placebo controlled trial of 158 subjects. Outcome: Change in Total Learning (Trials 1-5) on the California Verbal Learning Test-2nd Edition-(CVLT-II) AND Change in Symbol Digit Modalities Test (SDMT) (at day 90
Patients with all types of MS (Relapsing Remitting, Secondary Progressive, or Primary Progressive) are eligible to participate. Participants will undergo detailed cognitive assessment before initiating treatment and again after 90 days of treatment, to determine whether Caprylic Triglyceride demonstrates a benefit over placebo. Dosage: 40 gram packet orally once a day Duration of Treatment: 90 days Analyses: Interim analyses will be conducted after 72 subjects have completed the trial and objective STOP criteria for efficacy and futility have been defined in the protocol. Final analyses will be an intent-to-treat (ITT) analysis to evaluate each of the primary aims.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
124
Caprylic Triglyceride is a medical food that is used for the dietary management of the metabolic processes associated with mild to moderate Alzheimer's disease.
Placebo (40 gram packet orally once a day for 90 days)
University of Miami Miller School of Medicine
Miami, Florida, United States
Change in Total Learning (Trials 1-5) on the California Verbal Learning Test-2nd Edition (CVLT-II) (range from 0 to 80)
measure of verbal learning and memory
Time frame: Baseline and 90 days
Change in Symbol Digit Modalities Test (SDMT) (range from 0-110)
measure of processing speed and attention
Time frame: Baseline and 90 days
Number of participants reporting adverse events
The number of participants experiencing adverse events in the active treatment and placebo group will be examined.
Time frame: Baseline and 90 days
Change in EDSS
measure of disease severity
Time frame: Baseline and 90 days
Change in Beck Depression Inventory -2nd edition (BDI-II)
Self-report depression scale
Time frame: Baseline and 90 days
Change in Multiple Sclerosis Quality of Life Inventory (MSQOL-54)
Quality of life inventory
Time frame: Baseline and 90 days
Change in Modified Fatigue Impact Scale (MFIS)
Self-report Fatigue scale
Time frame: Baseline and 90 days
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