A Prospective Pilot Study to Compare the Effectiveness of Prolonged Fasting and Low Glycemic Load Treatment in Respect to the Health Related Quality of Life in Multiple Sclerosis (IGEL)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Markus Bock, MD, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT01538355

First received: February 15, 2012

Last updated: January 25, 2013

Last verified: January 2013

History of Changes

Purpose

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 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 palatable 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 prospective pilot study the patients are 1. on a low glycemic load treatment about 24 weeks or 2. on a 7 days caloric restriction followed by a Mediterranean diet pattern about 23 weeks or 3. on a common diet to serve as MS control group for about 24 weeks. The investigators will then assess the differences between the groups.

Condition	Intervention
Multiple Sclerosis	Other: Comparison of prolonged fasting and low glycemic load treatment on health related quality of life in multiple sclerosis.

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective Randomised Controlled Pilot Study to Compare the Effectiveness of Prolonged Fasting and Low Glycemic Load Treatment in Respect to the Health Related Quality of Life in Multiple Sclerosis

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

Health related quality of life and tolerability [ Time Frame: 5 Visits ] [ Designated as safety issue: No ]
12 subscales with two summary scores physical health und mental health

Secondary Outcome Measures:

Efficacy and safety (Number of Participants with Adverse Events and Fatigue Scores on the Visual Analog Scale) [ Time Frame: 5 Visits ] [ Designated as safety issue: Yes ]
Multiple sclerosis functional composite; body composition; body weight; lipid profile, liver enzymes, insulin, glucagon

Estimated Enrollment:	60
Study Start Date:	December 2011
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: prolonged fasting 7 days fasting (Buchinger method) followed by a mediterranean, vegetarian weighted diet	Other: Comparison of prolonged fasting and low glycemic load treatment on health related quality of life in multiple sclerosis.
Active Comparator: low glycemic load treatment low glycemic load treatment	Other: Comparison of prolonged fasting and low glycemic load treatment on health related quality of life in multiple sclerosis.
Active Comparator: MS control standard diet	Other: Comparison of prolonged fasting and low glycemic load treatment on health related quality of life in multiple sclerosis.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Relapsing remitting MS
Stable immunomodulatory treatment or no treatment at least 6 months prior to inclusion
Expanded disability status scale < 5
Body mass index (BMI) > or = 20 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
Attack or steroid therapy < 30 days prior to screening
Diabetes or any metabolic defects
Bulimia
Anorexia
Drug abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538355

Locations

Germany
Charité-Universitätsmedizin
Berlin, Germany, 10117

Sponsors and Collaborators

Charite University, Berlin, Germany

More Information

No publications provided

Responsible Party:	Markus Bock, MD, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT01538355 History of Changes
Other Study ID Numbers:	IGEL
Study First Received:	February 15, 2012
Last Updated:	January 25, 2013
Health Authority:	Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:

multiple sclerosis
diet
fasting
caloric restriction

low glycemic load treatment
modified ketogenic diet
ketogenic diet

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases

Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013

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