CClinicalTrials.gg
CompletedNCT05712408Updated Aug 14, 2023

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

An interventional study of 800g Challenge in Multiple Sclerosis, sponsored by University of North Texas, Denton, TX. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by University of North Texas, Denton, TX · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Multiple Sclerosis
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 16 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University of North Texas, Denton, TX is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • electronic medical implant, such as a heart pacemaker or an implantable cardioverter defibrillator (ICD)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Diet Intervention

    8 week non-restrictive diet program

    Behavioral: 800g Challenge

Interventions

  • Behavioral800g 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.

06

What researchers measure

Primary outcomes

  1. Metabolic Health

    Fasted Cholesterol and Gloucose

    Time frame: From recruitment to end of 8 week intervention

  2. Body Weight

    Change in Body Weight

    Time frame: From recruitment to end of 8 week intervention

  3. Body Fat

    Change in Body Fat Percentage

    Time frame: From recruitment to end of 8 week intervention

Secondary outcomes

  1. 6-Minute Walk

    Change in 6-Minute Walk Distance

    Time frame: From recruitment to end of 8 week intervention

  2. 25-Foot Walk

    Change in 25-Foot Walk Speed

    Time frame: From recruitment to end of 8 week intervention

  3. Cognitive Assessments

    Change in the Brief International Cognitive Assessment in MS Scores. Scores range from 0-208 with higher scores indicating greater cognitive functioning.

    Time frame: From recruitment to end of 8 week intervention

  4. Fatigue

    Change in Fatigue Severity Scale Scores. Scores range from 1-7 with higher scores indicating greater fatigue.

    Time frame: From recruitment to end of 8 week intervention

  5. 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.

    Time frame: From recruitment to end of 8 week intervention

Other outcomes

  1. Acceptability of Intervention

    Participants ratings of satisfaction with the diet program. Scores range from 1-5 with higher scores indicating greater satisfaction.

    Time frame: From recruitment to end of 8 week intervention

07

Study locations

1 site
  • University of North Texas
    Denton, Texas 76203, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05712408
Lead sponsor
University of North Texas, Denton, TX
Responsible party
Sponsor
First posted
Feb 3, 2023
Start date
Jan 1, 2023
Primary completion
Apr 19, 2023
Completion
Apr 19, 2023
Last update
Aug 14, 2023

Study contacts

Stephanie Silveira
principal investigator · University of North Texas Health Science Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion