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: November 21, 2013
Last verified: November 2013
  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:


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 Study Completion Date: September 2014
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 68 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 < 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 21, 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 July 22, 2014