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

Relapsing-Remitting Multiple Sclerosis Clinical Trial

— IGEL  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538355
• Other study ID #: IGEL
• Status: Completed
• Phase: N/A
• Start date: July 30, 2012
• Est. completion date: June 23, 2020

Study information

• Verified date: April 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 23, 2020
• Est. primary completion date: February 28, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Prolonged Fasting
Patients enhance their regular diet with an initial 7-day fasting episode.
• Ketogenic low glycemic load treatment
6 months of ketogenic low glycemic load treatment from the study outset.
• Control diet
Patients stay on their regular diet.

Locations

Country	Name	City	State
Germany	Charité-Universitätsmedizin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Kim DY, Hao J, Liu R, Turner G, Shi FD, Rho JM. Inflammation-mediated memory dysfunction and effects of a ketogenic diet in a murine model of multiple sclerosis. PLoS One. 2012;7(5):e35476. doi: 10.1371/journal.pone.0035476. Epub 2012 May 2. — View Citation

Piccio L, Stark JL, Cross AH. Chronic calorie restriction attenuates experimental autoimmune encephalomyelitis. J Leukoc Biol. 2008 Oct;84(4):940-8. doi: 10.1189/jlb.0208133. Epub 2008 Aug 4. — View Citation

Swidsinski A, Dörffel Y, Loening-Baucke V, Gille C, Göktas Ö, Reißhauer A, Neuhaus J, Weylandt KH, Guschin A, Bock M. Reduced Mass and Diversity of the Colonic Microbiome in Patients with Multiple Sclerosis and Their Improvement with Ketogenic Diet. Front — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Visit: Baseline, month 1, month 3 and month 6
Secondary	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	Visits: Baseline, month 1, month 3 and month 6