NCT03740295

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 multiple-sclerosis

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_2 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

October 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2019

Completed
Last Updated

October 31, 2019

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

October 5, 2018

Last Update Submit

October 30, 2019

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

  • Lipid peroxidation Malondialdehyde (MDA)

    Malondialdehyde (MDA) will be used as perioxidation marker. It is based on the reaction of thiobarbituric with malondialdehyde, product of the splitting of hydroperoxides, thus forming a color that can be measured directly. Its analysis is used for its good practicability and simplicity, but it lacks sensitivity, so it is recommended, to increase it, to use fluorometric or chromatographic procedures.

    0-4 months

  • Tumor necrosis factor alfa (TNF-alpha)

    Plasma concentrations of inflammatory markers (IL-6 and TNF-a) were determined by using a multiplex ELISA (Human ProInflammatory II 4-Plex Ultra-Sensitive Kit; Meso Scale Diagnostics).

    0-4 months

  • Interleukin 6 (IL-6)

    Plasma concentrations of inflammatory markers (IL-6 and TNF-a) were determined by using a multiplex ELISA (Human ProInflammatory II 4-Plex Ultra-Sensitive Kit; Meso Scale Diagnostics).

    0-4 months

Secondary Outcomes (27)

  • Quantitative electroencephalogram (QEEG)

    0-4 months

  • Betahydroxybutyrate

    0-4 months

  • C-reactive protein

    0-4 months

  • Haptoglobin

    0-4 months

  • Field oxide (FOX)

    0-4 months

  • +22 more secondary outcomes

Study Arms (2)

Control Multiple Sclerosis

PLACEBO COMPARATOR
Other: Placebo

Intervention Multiple Sclerosis

EXPERIMENTAL
Dietary Supplement: Coconut oil and epigallocatechin gallate

Interventions

Coconut oil and epigallocatechin gallateDIETARY_SUPPLEMENT

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)

Intervention Multiple Sclerosis
PlaceboOTHER

Lactose

Control Multiple Sclerosis

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with coconut oil intolerance or other chronic metabolic pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

José Enrique de la Rubia Ortí

Valencia, 46007, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Coconut Oilepigallocatechin gallate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Dietary FatsFatsLipidsPlant OilsOils

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 5, 2018

First Posted

November 14, 2018

Study Start

October 5, 2018

Primary Completion

January 5, 2019

Study Completion

February 5, 2019

Last Updated

October 31, 2019

Record last verified: 2019-10

Locations

ES(1)