Relapsing-Remitting Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, diet, prolonged fasting, caloric restriction, ketogenic low glycemic load treatment, health related quality of life, ketogenic diet, neurodegeneration, neuroinflammation
Brief 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.
Detailed 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.
Interventions
OTHERProlonged Fasting
Patients enhance their regular diet with an initial 7-day fasting episode.
OTHERKetogenic low glycemic load treatment
6 months of ketogenic low glycemic load treatment from the study outset.
OTHERControl diet
Patients stay on their regular diet.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Multiple Sclerosis Quality of Life-54 questionnaire: Proof of feasibility at 6 months. | 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
| Measure | Time frame | Description |
|---|---|---|
| Adherence rates, number of participants with adverse events and laboratory parameters at 6 months. | 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 |
Countries
Germany
Outcome results
None listed