An interventional study of Prolonged Fasting and Ketogenic low glycemic load treatment in Relapsing-Remitting Multiple Sclerosis, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years to 68 Years. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment
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.
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 48 is close to the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients undergo an initial 7-day fasting episode.
Other: Prolonged Fasting
Patients receive a ketogenic low glycemic load treatment from the outset of the study.
Other: Ketogenic low glycemic load treatment
Patients stay on their regular diet.
Other: Control diet
Patients enhance their regular diet with an initial 7-day fasting episode.
6 months of ketogenic low glycemic load treatment from the study outset.
Patients stay on their regular diet.
Change from Baseline in Multiple Sclerosis Quality of Life-54 questionnaire: Proof of feasibility at 6 months.
Two summary scores: physical health und mental health, 12 subscales and 2 single item scales.
Time frame: Visit: Baseline, month 1, month 3 and month 6
Adherence rates, number of participants with adverse events and laboratory parameters at 6 months.
Multiple sclerosis functional composite; fatigue scores, body composition; body weight; lipid profile, liver enzymes, insulin, glucagon
Time frame: Visits: Baseline, month 1, month 3 and month 6
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany