Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple Sclerosis

Fundación Universidad Católica de Valencia San Vicente Mártir

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Other: Placebo; Dietary Supplement: Coconut oil and epigallocatechin gallate

Study type: Interventional

Funder types: Other

Identifiers

NCT03740295

FundacionUCV

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Multiple Sclerosis patients older than 19 years ans under 65 who sign informed consent of the study

Exclusion criteria

• Patients with coconut oil intolerance or other chronic metabolic pathologies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Control Multiple Sclerosis

Placebo Comparator group

Treatment:

Other: Placebo

Intervention Multiple Sclerosis

Experimental group

Treatment:

Dietary Supplement: Coconut oil and epigallocatechin gallate