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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT01538355

Collaborator

(none)

Enrollment

Location

Arms

94.8

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsing-Remitting Multiple Sclerosis	Other: Prolonged Fasting Other: Ketogenic low glycemic load treatment Other: Control diet	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomised Controlled Pilot Study to Compare the Effects of Prolonged Fasting and Ketogenic Low Glycemic Load Treatment on Health Related Quality of Life in Relapsing-remitting Multiple Sclerosis.

Actual Study Start Date :

Jul 30, 2012

Actual Primary Completion Date :

Feb 28, 2013

Actual Study Completion Date :

Jun 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prolonged fasting Patients undergo an initial 7-day fasting episode.	Other: Prolonged Fasting Patients enhance their regular diet with an initial 7-day fasting episode.
Experimental: Ketogenic low glycemic load treatment Patients receive a ketogenic low glycemic load treatment from the outset of the study.	Other: Ketogenic low glycemic load treatment 6 months of ketogenic low glycemic load treatment from the study outset.
Experimental: Control diet Patients stay on their regular diet.	Other: Control diet Patients stay on their regular diet.

Arm

Intervention/Treatment

Experimental: Prolonged fasting

Patients undergo an initial 7-day fasting episode.

Other: Prolonged Fasting

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

Experimental: Ketogenic low glycemic load treatment

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

Other: Ketogenic low glycemic load treatment

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

Experimental: Control diet

Patients stay on their regular diet.

Other: Control diet

Patients stay on their regular diet.

Outcome Measures

Primary Outcome Measures

Change from Baseline in Multiple Sclerosis Quality of Life-54 questionnaire: Proof of feasibility at 6 months. [Visit: Baseline, month 1, month 3 and month 6]
Two summary scores: physical health und mental health, 12 subscales and 2 single item scales.

Secondary Outcome Measures

Adherence rates, number of participants with adverse events and laboratory parameters at 6 months. [Visits: Baseline, month 1, month 3 and month 6]
Multiple sclerosis functional composite; fatigue scores, body composition; body weight; lipid profile, liver enzymes, insulin, glucagon

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 68 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.