A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis (MS)

NCT ID: NCT02846558

Last Updated: 2018-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-07-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Calorie Restriction - Frequent Patient Communication

MS patients receiving monthly natalizumab infusions will use the LoseIt! smartphone application to log daily food consumption. Data from the app will be collected at follow-up visits. Patients will receive initial training in using the app, and then receive weekly supportive messages encouraging them to adhere to the calorie restriction diet between 3- and 6-month followup visits. Results will be compared primarily to those collected from the Standard of Care arm.

Group Type: EXPERIMENTAL

Frequent Patient Interaction

Intervention Type: OTHER

Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.

LoseIt! Smartphone Application

Intervention Type: DEVICE

Patients will be trained by study staff to download the LoseIt! application, and use it to log all food intake throughout the study duration. Data collected from the application will be the primary measure of adherence to dietary changes.

Timing Restriction

MS patients receiving monthly natalizumab infusions who are ineligible for the calorie restriction portion of the study (the Frequent Patient Activation and Standard of Care arms) will be offered the option to enroll in the second part of the study, assessing differences in outcomes between daily 16-hour fasting periods and no dietary changes. Patients in the second part of the study randomized to this arm will consume their normal daily food intake, but restrict eating to an 8-hour period during the day. Results will be compared to patients who do not make any changes to their diet, the No Change arm.

Group Type: EXPERIMENTAL

Timing Restriction

Intervention Type: BEHAVIORAL

Patients continue to follow their normal diet, but limit food intake to an 8-hour period during the day.

Calorie Restriction - Communication Standard of Care

MS patients receiving monthly natalizumab infusions will use the LoseIt! smartphone application to log daily food consumption. Data from the app will be collected at follow-up visits. Besides initial training with the application and 3- and 6-month follow up exams, participants will not receive additional support or interaction from the study team.Results will be compared with those collected from the Frequent Patient Interaction arm.

Group Type: PLACEBO_COMPARATOR

LoseIt! Smartphone Application

Intervention Type: DEVICE

Patients will be trained by study staff to download the LoseIt! application, and use it to log all food intake throughout the study duration. Data collected from the application will be the primary measure of adherence to dietary changes.

No Diet Change

MS patients receiving natalizumab infusions who were ineligible for the calorie restriction portion of the study (e.g. body mass index \< 25 kg/m\^2) or did not wish to participate in calorie restriction, may elect to be part of the second portion of the study. If so, they may be randomized to this arm, in which no changes are made to amount or timing of daily food intake. Results will be compared with the experimental Timing arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Frequent Patient Interaction

Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.

Intervention Type: OTHER

Timing Restriction

Patients continue to follow their normal diet, but limit food intake to an 8-hour period during the day.

Intervention Type: BEHAVIORAL

LoseIt! Smartphone Application

Patients will be trained by study staff to download the LoseIt! application, and use it to log all food intake throughout the study duration. Data collected from the application will be the primary measure of adherence to dietary changes.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellen Mowry, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

References

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.

Reference Type: DERIVED

PMID: 32408153 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00105123

Identifier Type: -

Identifier Source: org_study_id