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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05712408
Enrollment
16
Registered
2023-02-03
Start date
2023-01-01
Completion date
2023-04-19
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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).

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.

Sponsors

University of North Texas, Denton, TX
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Body FatFrom recruitment to end of 8 week interventionChange in Body Fat Percentage
Metabolic HealthFrom recruitment to end of 8 week interventionFasted Cholesterol and Gloucose
Body WeightFrom recruitment to end of 8 week interventionChange in Body Weight

Secondary

MeasureTime frameDescription
Cognitive AssessmentsFrom recruitment to end of 8 week interventionChange in the Brief International Cognitive Assessment in MS Scores. Scores range from 0-208 with higher scores indicating greater cognitive functioning.
Health-Related Quality of LifeFrom recruitment to end of 8 week interventionChange in SF-12 Scores. Scores range from 0-100 with higher scores indicating greater health-related quality of life.
FatigueFrom recruitment to end of 8 week interventionChange in Fatigue Severity Scale Scores. Scores range from 1-7 with higher scores indicating greater fatigue.
6-Minute WalkFrom recruitment to end of 8 week interventionChange in 6-Minute Walk Distance
25-Foot WalkFrom recruitment to end of 8 week interventionChange in 25-Foot Walk Speed

Other

MeasureTime frameDescription
Acceptability of InterventionFrom recruitment to end of 8 week interventionParticipants ratings of satisfaction with the diet program. Scores range from 1-5 with higher scores indicating greater satisfaction.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026