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Completed

NCT Number: NCT05712408

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Texas

Denton, Texas, 76203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Metabolic Health

    Time frame: From recruitment to end of 8 week intervention

    Fasted Cholesterol and Gloucose

  2. Body Weight

    Time frame: From recruitment to end of 8 week intervention

    Change in Body Weight

  3. Body Fat

    Time frame: From recruitment to end of 8 week intervention

    Change in Body Fat Percentage

Secondary outcomes

  1. 6-Minute Walk

    Time frame: From recruitment to end of 8 week intervention

    Change in 6-Minute Walk Distance

  2. 25-Foot Walk

    Time frame: From recruitment to end of 8 week intervention

    Change in 25-Foot Walk Speed

  3. Cognitive Assessments

    Time frame: From recruitment to end of 8 week intervention

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

  4. Fatigue

    Time frame: From recruitment to end of 8 week intervention

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

  5. Health-Related Quality of Life

    Time frame: From recruitment to end of 8 week intervention

    Change in SF-12 Scores. Scores range from 0-100 with higher scores indicating greater health-related quality of life.

Other outcomes

  1. Acceptability of Intervention

    Time frame: From recruitment to end of 8 week intervention

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

Sponsors and collaborators

Lead sponsor

University of North Texas, Denton, TX

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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