NCT03740295

Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple Sclerosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Based on the fact that the fundamental pathogenic mechanism of the Multiple Sclerosis (MS) disease is neuroinflammation, related in turn to cellular oxidation and mitochondrial alterations, this project aims to assess the impact of a nutritional intervention on the evolution of MS patients in their different slopes. To this end, the administration of medium-chain triglycerides, whose metabolism produces the increase of ketone bodies in the blood, will be carried out; and another of the antioxidant polyphenol epigallocatechin gallate. This procedure will be applied over 6 months, based on a isocaloric Mediterranean diet, with a population for the study of 80 patients with different variants of the disease. The assessment of the intervention will be carried out every two months, at motor-functional, anthropometric, cognitive and emotional, inflammatory, and oxidation levels.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Coconut oil and epigallocatechin gallate	600 mg of epigallocatechin gallate (EGCG) and 60 ml of coconut oil (3600 mg of TGCM) per day, divided into two doses (one in the morning and one at noon)
OTHER	Placebo	Lactose

Timeline

• Start date: 2018-10-05
• Primary completion: 2019-01-05
• Completion: 2019-02-05
• First posted: 2018-11-14
• Last updated: 2019-10-31

Locations

1 site across 1 country: Spain