NCT01883648

Study to Evaluate Coconut Oil for Alzheimer's Disease

A Randomized, Double-Blind, Placebo-Controlled, 6 Month Cross-Over Study to Evaluate the Efficacy of Coconut Oil (Fuel for Thought™) Treatment for Subjects With Mild to Moderate Alzheimer's Disease

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, cross over study to determine the efficacy of coconut oil in subjects with mild to moderate Alzheimer's disease.

Detailed description

This is a randomized, double-blind, placebo-controlled, cross over study to determine the efficacy of coconut oil (a proprietary blend of coconut and medium chain triglyceride oils, administered orally three times daily) to subjects with Alzheimer's disease who have been screened for ApoE 4 allele. The study medication formula is Cognate Nutritionals Fuel for Thought™. Approximately 65 subjects will be treated with a coconut oil beverage (Fuel for Thought™) or placebo for three months, and then given a 3-5 day interim wash out period. After this, subjects will resume with three months treatment in opposite treatment arm. Total treatment period is 6 months.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Coconut Oil Beverage	There are 2 treatment arms: Fuel for Thought™ and placebo, with a treatment allocation of 1:1. After 3 months of treatment in one group, subjects will have a 3-5 day wash-out period before receiving the alternate (opposite) treatment for 3 months.
OTHER	Placebo Beverage	There are 2 treatment arms: Fuel for Thought™ and placebo, with a treatment allocation of 1:1. After 3 months of treatment in one group, subjects will have a 3-5 day wash-out period before receiving the alternate (opposite) treatment for 3 months.

Timeline

• Start date: 2013-06-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2013-06-21
• Last updated: 2017-04-28

Locations

1 site across 1 country: United States