A Pilot Trial to Test the Feasibility of Prolonged Fasting and Ketogenic Diet in Relapsing-remitting Multiple Sclerosis (IGEL)
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|ClinicalTrials.gov Identifier: NCT01538355|
Recruitment Status : Completed
First Posted : February 24, 2012
Last Update Posted : April 8, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Relapsing-Remitting Multiple Sclerosis||Other: Prolonged Fasting Other: Ketogenic low glycemic load treatment Other: Control diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||July 30, 2012|
|Actual Primary Completion Date :||February 28, 2013|
|Actual Study Completion Date :||June 23, 2020|
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.
- 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.
- Adherence rates, number of participants with adverse events and laboratory parameters at 6 months. [ Time Frame: 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
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|Ages Eligible for Study:||18 Years to 68 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538355
|Berlin, Germany, 10117|
|Principal Investigator:||Markus Bock, MD||Charité-Universitätsmedizin Berlin, Berlin Germany|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Markus Bock, MD, Principal Investigator, Charite University, Berlin, Germany|
|Other Study ID Numbers:||
|First Posted:||February 24, 2012 Key Record Dates|
|Last Update Posted:||April 8, 2021|
|Last Verified:||April 2021|
ketogenic low glycemic load treatment
health related quality of life
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases