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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Multiple Sclerosis Quality of Life-54 questionnaire: Proof of feasibility at 6 months.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
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.
Investigators
Markus Bock, MD
Principal Investigator
Charite University, Berlin, Germany
Eligibility Criteria
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
- •Drug abuse
Outcomes
Primary Outcomes
Change from Baseline in Multiple Sclerosis Quality of Life-54 questionnaire: Proof of feasibility at 6 months.
Time Frame: 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 Outcomes
- Adherence rates, number of participants with adverse events and laboratory parameters at 6 months.(Visits: Baseline, month 1, month 3 and month 6)