Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-29 @ 4:02 AM
Study NCT ID:
NCT03740295
Status:
COMPLETED
Last Update Posted:
2019-10-31
First Post:
2018-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple Sclerosis
Sponsor:
Fundación Universidad Católica de Valencia San Vicente Mártir
Organization:
Study Overview
Official Title:
Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: