Clinical trial NCT02846558: A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis (MS)
Official title: A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: calorie restriction
weight loss
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pragmatic, single-blinded randomized trial of improving adherence to dietary interventions in patients with MS who are receiving monthly natalizumab infusions.

Detailed description: MS affects at least 400,000 people in the US alone, and its incidence has increased in the past 50 years, likely due to changing environmental risk factors. Recent research suggests that diet may be a critical factor in the development of MS. The "Western diet", high in sugar, fat, and salt, may influence MS risk and progression by directly affecting the immune system, altering gut bacteria, and changing metabolism.

Studying patients with MS who are overweight and obese may be relevant as obesity can cause chronic low-grade inflammation, potentially worsening MS symptoms. Diet modification represents an interesting potential therapy for MS, particularly calorie restriction and fasting, which have been associated with reduced markers of inflammation. In addition to these direct effects, weight optimization may lead to improvements in MS-related symptoms, like fatigue, and overall quality of life.

This is a single-blinded randomized trial of adherence to a dietary intervention in patients with MS who are receiving monthly natalizumab infusions. The study will evaluate how use of technology may help patients with MS adhere to a calorie restricted diet. It will also evaluate the effect of weight loss on fatigue and quality of life in patients with MS. A second part of the study will evaluate if shortening the period during the day in which people consume their typical food amounts leads to improvements in patient-reported outcomes.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) ≥ 25 kg/m\^2 for calorie restriction study
* BMI \< 25 kg/m\^2, or ≥ 25 kg/m\^2 if participant was unwilling to enroll in calorie restriction study
* Smartphone with the ability to download and use the LoseIt! application (calorie restriction only)
* Smartphone with the ability to take and store photos (calorie timing only)

Exclusion Criteria:

* History of diabetes requiring medication
* Currently pregnant or breastfeeding
* History of an eating disorder
* Currently taking warfarin
* History of major surgery within past 3 months

Primary outcomes:
measure: Adherence
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Baseline and 6 months
measure: Weight Change
timeFrame: Baseline and 6 months
measure: Weight Change Among Adherent Participants
timeFrame: Baseline and 6 months
measure: Functional Assessment in MS Score
timeFrame: Baseline and 6 months
measure: Fatigue
timeFrame: Baseline and 6 months
measure: Sleep Quality
timeFrame: Baseline and 6 months
measure: Self-esteem
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Ellen Mowry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roman SN, Fitzgerald KC, Beier M, Mowry EM. Safety and feasibility of various fasting-mimicking diets among people with multiple sclerosis. Mult Scler Relat Disord. 2020 Jul;42:102149. doi: 10.1016/j.msard.2020.102149. Epub 2020 May 6.