Clinical trial NCT03740295: Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple Sclerosis
Official title: Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Lead sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Sponsor class: OTHER
Collaborators: name: Valencian Institute of Neurorehabilitation Foundation
First posted: 2018-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Lipid peroxidation Malondialdehyde (MDA)
timeFrame: 0-4 months
measure: Tumor necrosis factor alfa (TNF-alpha)
timeFrame: 0-4 months
measure: Interleukin 6 (IL-6)
timeFrame: 0-4 months
Secondary outcomes:
measure: Quantitative electroencephalogram (QEEG)
timeFrame: 0-4 months
measure: Betahydroxybutyrate
timeFrame: 0-4 months
measure: C-reactive protein
timeFrame: 0-4 months
measure: Haptoglobin
timeFrame: 0-4 months
measure: Field oxide (FOX)
timeFrame: 0-4 months
measure: Total antioxidants (TEAC)
timeFrame: 0-4 months
measure: Copper reduction capacity (CUPRAC)
timeFrame: 0-4 months
measure: Iron reduction capacity (FRAP)
timeFrame: 0-4 months
measure: Paraoxonase 1 (PON1)
timeFrame: 0-4 months
measure: Anxiety
timeFrame: 0-4 months
measure: Depression
timeFrame: 0-4 months
measure: Satiety
timeFrame: 0-4 months
measure: Sociodemographic
timeFrame: 0 months
measure: Berg
timeFrame: 0-4 months
measure: Exercise tolerance
timeFrame: 0-4 months
measure: Gait speed
timeFrame: 0-4 months
measure: Physical function and symptoms
timeFrame: 0-4 months
measure: Neurological impairment
timeFrame: 0-4 months
measure: Manual dexterity
timeFrame: 0-4 months
measure: Hand Grip Strength
timeFrame: 0-4 months
measure: Muscle power
timeFrame: 0-4 months
measure: Muscle Strength Assessment Dynamometer (NEDDFM/IBV )
timeFrame: 0-4 months
measure: Body diameters
timeFrame: 0-4 months
measure: Body perimeters
timeFrame: 0-4 months
measure: Skinfold calipe
timeFrame: 0-4 months
measure: Height
timeFrame: 0-4 months
measure: Weight
timeFrame: 0-4 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: José Enrique de la Rubia Ortí
Study officials:
References: