Examining the Impact of an Online, Non-restrictive Diet Among Persons With Multiple Sclerosis

Overview

The current study aims to test an online, non-restrictive diet among persons with multiple sclerosis (MS). Diet is the number one searched second-line therapy among persons with MS, however there are currently no established dietary approaches to improve health and wellbeing among persons with MS. Participants will complete the 8-week diet program using an online application. The primary research question is whether the diet program is acceptable and can improve general health indicators including cholesterol, glucose, body weight, body fat as well as MS symptoms (i.e., walking, cognition, fatigue, and quality of life).

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Other
  • Masking: None (Open Label)
• Study Primary Completion Date: May 1, 2023

Interventions

• Behavioral: 800g Challenge
  • The intervention will involve 8 weeks of an online diet program. Outcomes testing will occur at baseline and post-intervention (following 8 week diet program). During the first 4 weeks, participants will receive educaitonal material and log their daily points in an online application and attend a weekly check-in call with members of the research team. During weeks 5-8, participants will log their daily points in the online application.

Arms, Groups and Cohorts

• Experimental: Diet Intervention
  • 8 week non-restrictive diet program

Clinical Trial Outcome Measures

Primary Measures

• Metabolic Health
  • Time Frame: From recruitment to end of 8 week intervention
  • Fasted Cholesterol and Gloucose
• Body Weight
  • Time Frame: From recruitment to end of 8 week intervention
  • Change in Body Weight
• Body Fat
  • Time Frame: From recruitment to end of 8 week intervention
  • Change in Body Fat Percentage

Secondary Measures

• 6-Minute Walk
  • Time Frame: From recruitment to end of 8 week intervention
  • Change in 6-Minute Walk Distance
• 25-Foot Walk
  • Time Frame: From recruitment to end of 8 week intervention
  • Change in 25-Foot Walk Speed
• Cognitive Assessments
  • Time Frame: From recruitment to end of 8 week intervention
  • Change in the Brief International Cognitive Assessment in MS Scores
• Fatigue
  • Time Frame: From recruitment to end of 8 week intervention
  • Change in Fatigue Severity Scale Scores
• Health-Related Quality of Life
  • Time Frame: From recruitment to end of 8 week intervention
  • Change in SF-12 Scores

Participating in This Clinical Trial

Inclusion Criteria

• age 18-70 years – a self-reported diagnosis of multiple sclerosis – relapse free in past 30 days – non-pregnant – willing and able to visit University of North Texas on two testing occasions Exclusion Criteria:

• electronic medical implant, such as a heart pacemaker or an implantable cardioverter defibrillator (ICD)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • University of North Texas, Denton, TX
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Stephanie Silveira, Principal Investigator, University of North Texas Health Science Center
• Overall Contact(s)
  • Stephanie L. Silveira, 940-565-2373, stephanie.silveira@unt.edu