Multiple Sclerosis and the Effects of Ketogenic Diet Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorIRCCS National Neurological Institute "C. Mondino" Foundation
About this trial
Multiple sclerosis (MS) is an inflammatory and immune-mediated neurological disease with multifactorial etiology. The specific etiopathogenetic mechanisms of MS are still unknown but it is clear that it results from a combination of genetic and environmental factors. Several studies have reported the possible role of diet as a risk factor for MS and its progression. To date, many dietary patterns and their association with MS have been studied, but data is still limited and inconclusive. Mediterranean Diet (MedDiet) has been associated with a lower risk of developing MS, compared to a Western-style diet. In one of investigators' studies, higher MedDiet adherence was associated with a 6-fold greater likelihood of having lower disease severity than those with low adherence. A significant restriction of carbohydrates (up to ketogenesis) can have beneficial effects on various parameters (inflammatory markers, oxidative stress, altered glucose metabolism) which are altered in subjects with MS. Ketogenic diet therapies (KDTs) have been recommended mainly for children with drug-resistant epilepsy, but in recent years they have been applied to Multiple Sclerosis. Preclinical studies in animal models evaluating the efficacy of KDTs in experimental autoimmune encephalomyelitis (EAE) found a beneficial effect of diet in slowing of disease progression, improvement of motor disability, reduction of inflammatory cytokines and reactive oxygen species. In a randomized study, improvements in health-related quality of life (HRQL) scores and a slight decrease in EDSS scores were found. An open-label, single-arm study of 20 patients with RRMS also reported that, after 6 months of MAD, no subjects had new or enlarging FLAIR/T2 lesions, with a significant improvement in the EDSS score, the Modified Fatigue Impact Scale subscales and arm. A 3-arm parallel-arm randomized controlled pilot study was planned to determine the effectiveness of a modified Atkins diet (MAD) compared to a Mediterranean diet (MedDiet) on quality of life in a population with MS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of relapsing-remitting MS (RRMS) or progressive MS (PMS)
Age between 18 and 60 years
BMI between 18.5 kg/m2 and 39.9 kg/m2
If on disease-modifying drugs, stable for 6 months, or no use of drugs in the previous 6 months
Disqualifiers
Patients actively engaged in a weight loss program or other specific diet (e.g. vegetarian, vegan); patients not willing to follow the assigned dietary pattern or patients with high adherence to MedDiet (MediLite score > 14)
Pregnancy or breastfeeding
Relapse or cortisone treatment within 30 days before study entry
Clinically relevant metabolic, progressive or malignant diseases
Trial design
Design model
Parallel
Treatments tested in this trial
Mediterranean Diet
Dietary supplementThe MedDiet will be planned according to the Mediterranean diet pyramid
Ketogenic Diet
Dietary supplementModified Atkins diet with a maximum of 20 g of carbohydrates per day.
Control group
Dietary supplementThe control group will be asked to continue their dietary and lifestyle habits
Treatment groups
111 Participants
are divided into 3 treatment groupsGroup A: Mediterranean DietOther 1 intervention
Group B: Ketogenic DietExperimental treatment 1 intervention
Group C: Control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
The CPH subscale of the Multiple Sclerosis Quality of Life-54 (MSQoL -54)
Quality of life will be assessed in terms of physical health referring to the CPH subscale of the MSQoL -54 after 6 months of treatment. ITS consists of 52 items grouped in 12 subscales plus two single items. All scores are transformed to scale from 0-100 and then added within each subscale to obtain the subtotal. By dividing the subtotal by the number of responses, the final score of the subscale is obtained. The scores final are in turn multiplied by a specific number at each subscale; adding the scores transformed in this way there is a value for "physical health" and one for "mental health". These two values, added, give the final score of the MSQoL-54. The higher scores demonstrate better HRQoL in patients.
Time frame
Evaluation at baseline and after 6 monthsSecondary outcomes
1
Expanded Disability Status Scale (EDSS)
Degree of disability, measured with the EDSS. Scores are based on examination by a neurologist, and climb by half unit increments from 0 to 10 as level of disability increases.They are based on the level of neurological impairment of eight functional systems in the brain: pyramidal, cerebellar, brainstem, sensory, bowel and bladder function, visual function, cerebral functions, other.
Time frame
Evaluation at baseline and after 6 months2
Multiple Sclerosis Functional Composite (MSFC)
It is a 3-part, standardized, quantitative assessment instrument for use in clinical studies, particularly clinical trials, of multiple sclerosis: Timed 25-Foot Walk (T25W) for leg function and ambulation, 9-Hole Peg Test (9HPT) for arm and hand function, and Paced Auditory Serial Addition Test (PASAT-3) for cognitive function. For these instruments there are not the minimum and the maximum values. Execution time is calculated. Longer time corresponds to worse outcome.
Time frame
Evaluation at baseline and after 6 months3
Modified Fatigue Impact Scale (MFIS)
This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The full-length MFIS consists of 21 items. MFIS total score can range from 0 to 84. MFIS score \> 38 indicates moderate to severe fatigue.
Time frame
Evaluation at baseline and after 6 months4
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality over a one-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Pittsburg scale's total score ranges from 0-21; where a higher score describes poorer sleep quality (score \>5= inadequate sleep, score \<5= adequate sleep)
Time frame
Evaluation at baseline and after 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
IRCCS National Neurological Institute "C. Mondino" Foundation
Lead sponsor
University of Pavia
Collaborator
Source ClinicalTrials.gov