NCT01848327

Caprylic Triglyceride for Treatment of Cognitive Impairments in Multiple Sclerosis

A Randomized Double-Blind Placebo-Controlled Study of Caprylic Triglyceride for Cognitive Impairment in Subjects With Multiple Sclerosis.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Relapsing Remitting MS
• Secondary Progressive MS
• Primary Progressive MS

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Caprylic Triglyceride	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.
DIETARY_SUPPLEMENT	Placebo	Placebo (40 gram packet orally once a day for 90 days)

Timeline

• Start date: 2013-02-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2013-05-07
• Last updated: 2018-01-25

Locations

1 site across 1 country: United States