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

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 Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: 800g Challenge

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Denton, Texas, United States, 76203
      • University of North Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-Minute Walk	Change in 6-Minute Walk Distance	From recruitment to end of 8 week intervention
25-Foot Walk	Change in 25-Foot Walk Speed	From recruitment to end of 8 week intervention
Cognitive Assessments	Change in the Brief International Cognitive Assessment in MS Scores. Scores range from 0-208 with higher scores indicating greater cognitive functioning.	From recruitment to end of 8 week intervention
Fatigue	Change in Fatigue Severity Scale Scores. Scores range from 1-7 with higher scores indicating greater fatigue.	From recruitment to end of 8 week intervention
Health-Related Quality of Life	Change in SF-12 Scores. Scores range from 0-100 with higher scores indicating greater health-related quality of life.	From recruitment to end of 8 week intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention	Participants ratings of satisfaction with the diet program. Scores range from 1-5 with higher scores indicating greater satisfaction.	From recruitment to end of 8 week intervention

Collaborators and Investigators

• Sponsor: University of North Texas, Denton, TX
• Investigators: Principal Investigator: Stephanie Silveira, University of North Texas Health Science Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): April 19, 2023
• Study Completion (Actual): April 19, 2023

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): February 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: IRB-21-629

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No