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NCT Number: NCT01538355

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

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.

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Inflammation Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nerve Degeneration Nervous System Diseases Neuroinflammatory Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité-Universitätsmedizin

Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prolonged fasting

Other

Patients enhance their regular diet with an initial 7-day fasting episode.

Ketogenic low glycemic load treatment

Other

6 months of ketogenic low glycemic load treatment from the study outset.

Control diet

Other

Patients stay on their regular diet.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study 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.

Acronym: IGEL

Important dates

Study start
2012
Primary completion
2013
Study completion
2020
First posted
Feb 24, 2012
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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