A Pilot Trial to Test the Feasibility of Prolonged Fasting and Ketogenic Diet in Relapsing-remitting Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-30

Study Completion Date

2020-06-23

Brief Summary

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It is well accepted that nutrition as an environmental factor is involved in the pathogenesis of multiple sclerosis. But is there a role for prolonged fasting and ketogenic low glycemic load treatment to alter the course of multiple sclerosis (MS)? The investigators think yes there is. Primarily the investigators want to detect if these diets are feasible for MS patients. Therefore the investigators examine the impact of this dietary intervention on the health related quality of life for individuals after 7 days, 3 months and 6 months in compare to baseline. Secondarily the investigators focus on endocrinological and immunological changes after 7 days, 3 months and 6 months in compare to baseline.

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Detailed Description

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In this controlled randomised pilot study the patients are allocated to 1. a ketogenic low glycemic load treatment from the outset of the study for 24 weeks or 2. enhance their regular diet with an initial 7-day fasting followed by a Mediterranean diet pattern until the study end or 3. stay on their regular diet (control group) from the outset of the study for 24 weeks. The investigators will then assess the differences between the groups.

Conditions

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Relapsing-Remitting Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prolonged fasting

Patients undergo an initial 7-day fasting episode.

Group Type EXPERIMENTAL

Prolonged Fasting

Intervention Type OTHER

Patients enhance their regular diet with an initial 7-day fasting episode.

Ketogenic low glycemic load treatment

Patients receive a ketogenic low glycemic load treatment from the outset of the study.

Group Type EXPERIMENTAL

Ketogenic low glycemic load treatment

Intervention Type OTHER

6 months of ketogenic low glycemic load treatment from the study outset.

Control diet

Patients stay on their regular diet.

Group Type EXPERIMENTAL

Control diet

Intervention Type OTHER

Patients stay on their regular diet.

Interventions

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Prolonged Fasting

Patients enhance their regular diet with an initial 7-day fasting episode.

Intervention Type OTHER

Ketogenic low glycemic load treatment

6 months of ketogenic low glycemic load treatment from the study outset.

Intervention Type OTHER

Control diet

Patients stay on their regular diet.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Relapsing remitting MS
* Stable immunomodulatory treatment or no treatment at least 6 months prior to inclusion
* Expanded disability status scale \< 7
* Body mass index (BMI) \> or = 18,5 OR BMI \> or = 45 with no risk factors
* Not pregnant or breast-feeding
* No serious mental health illness such as dementia or schizophrenia;
* No use of a weight loss therapy in the month prior to screening.

Exclusion Criteria

* Start or changes if immunomodulatory treatment \< 7 months prior to screening
* SPMS or PPMS
* Relapse or corticosteroid use \< 30 days prior to screening
* Diabetes or any metabolic defects
* Bulimia
* Anorexia
* Drug abuse

Minimum Eligible Age

18 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No