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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05712408
• Other study ID #: IRB-21-629
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: April 19, 2023

Study information

• Verified date: August 2023
• Source: University of North Texas, Denton, TX
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 19, 2023
• Est. primary completion date: April 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	University of North Texas	Denton	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of North Texas, Denton, TX

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Metabolic Health	Fasted Cholesterol and Gloucose	From recruitment to end of 8 week intervention
Primary	Body Weight	Change in Body Weight	From recruitment to end of 8 week intervention
Primary	Body Fat	Change in Body Fat Percentage	From recruitment to end of 8 week intervention
Secondary	6-Minute Walk	Change in 6-Minute Walk Distance	From recruitment to end of 8 week intervention
Secondary	25-Foot Walk	Change in 25-Foot Walk Speed	From recruitment to end of 8 week intervention
Secondary	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
Secondary	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
Secondary	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