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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03740295
Date of registration:	05/10/2018
Prospective Registration:	Yes
Primary sponsor:	Fundación Universidad Católica de Valencia San Vicente Mártir
Public title:	Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple Sclerosis
Scientific title:	Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple Sclerosis
Date of first enrolment:	October 5, 2018
Target sample size:	60
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03740295
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
Phase:	Phase 2

Countries of recruitment
Spain

Contacts

Key inclusion & exclusion 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

Age minimum: 19 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Dietary Supplement: Coconut oil and epigallocatechin gallate

Other: Placebo

Primary Outcome(s)

Interleukin 6 (IL-6) [Time Frame: 0-4 months]

Lipid peroxidation Malondialdehyde (MDA) [Time Frame: 0-4 months]

Tumor necrosis factor alfa (TNF-alpha) [Time Frame: 0-4 months]

Secondary Outcome(s)

Berg [Time Frame: 0-4 months]

C-reactive protein [Time Frame: 0-4 months]

Muscle Strength Assessment Dynamometer (NEDDFM/IBV ) [Time Frame: 0-4 months]

Skinfold calipe [Time Frame: 0-4 months]

Exercise tolerance [Time Frame: 0-4 months]

Gait speed [Time Frame: 0-4 months]

Manual dexterity [Time Frame: 0-4 months]

Total antioxidants (TEAC) [Time Frame: 0-4 months]

Muscle power [Time Frame: 0-4 months]

Neurological impairment [Time Frame: 0-4 months]

Haptoglobin [Time Frame: 0-4 months]

Anxiety [Time Frame: 0-4 months]

Sociodemographic [Time Frame: 0 months]

Body perimeters [Time Frame: 0-4 months]

Field oxide (FOX) [Time Frame: 0-4 months]

Weight [Time Frame: 0-4 months]

Hand Grip Strength [Time Frame: 0-4 months]

Height [Time Frame: 0-4 months]

Betahydroxybutyrate [Time Frame: 0-4 months]

Body diameters [Time Frame: 0-4 months]

Paraoxonase 1 (PON1) [Time Frame: 0-4 months]

Satiety [Time Frame: 0-4 months]

Copper reduction capacity (CUPRAC) [Time Frame: 0-4 months]

Depression [Time Frame: 0-4 months]

Iron reduction capacity (FRAP) [Time Frame: 0-4 months]

Physical function and symptoms [Time Frame: 0-4 months]

Quantitative electroencephalogram (QEEG) [Time Frame: 0-4 months]

Secondary ID(s)

FundacionUCV

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Valencian Institute of Neurorehabilitation Foundation

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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