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

NCT05712408 | Completed

• 1 other identifier: IRB-21-629
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 6-Minute Walk

  From recruitment to end of 8 week intervention

• 25-Foot Walk

  From recruitment to end of 8 week intervention

• Cognitive Assessments

  From recruitment to end of 8 week intervention

• Fatigue

  From recruitment to end of 8 week intervention

• Health-Related Quality of Life

  From recruitment to end of 8 week intervention

Other Outcomes (1)

• Acceptability of Intervention

  From recruitment to end of 8 week intervention

Study Arms (1)

Diet Intervention

EXPERIMENTAL

8 week non-restrictive diet program

Behavioral: 800g Challenge

Interventions

800g Challenge BEHAVIORAL

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.

Diet Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Texas, Denton, TX: lead

Study Sites (1)

University of North Texas

Denton, Texas, 76203, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Stephanie Silveira

  University of North Texas Health Science Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 3, 2023
• Study Start: January 1, 2023
• Primary Completion: April 19, 2023
• Study Completion: April 19, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)