Multiple SclerosisNCT05712408
Examining the Impact of an Online, Non-restrictive Diet Among Persons With Multiple Sclerosis
A study testing 800g Challenge in people with Multiple Sclerosis, run by University of North Texas, Denton, TX at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- 800g Challenge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 19 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- electronic medical implant, such as a heart pacemaker or an implantable cardioverter defibrillator (ICD)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- 800g Challenge
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
800g ChallengeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Diet Intervention | Experimental | 8 week non-restrictive diet program Receives: Behavioral: 800g Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Health
Fasted Cholesterol and Gloucose
Measured: From recruitment to end of 8 week intervention
Body Weight
Change in Body Weight
Measured: From recruitment to end of 8 week intervention
Body Fat
Change in Body Fat Percentage
Measured: From recruitment to end of 8 week intervention
Secondary outcomes (5)
6-Minute Walk
Change in 6-Minute Walk Distance
Measured: From recruitment to end of 8 week intervention
25-Foot Walk
Change in 25-Foot Walk Speed
Measured: From recruitment to end of 8 week intervention
Cognitive Assessments
Change in the Brief International Cognitive Assessment in MS Scores. Scores range from 0-208 with higher scores indicating greater cognitive functioning.
Measured: From recruitment to end of 8 week intervention
Fatigue
Change in Fatigue Severity Scale Scores. Scores range from 1-7 with higher scores indicating greater fatigue.
Measured: From recruitment to end of 8 week intervention
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.
Measured: From recruitment to end of 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Jan 2023
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas, Denton, TX
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Silveira, Principal investigator, University of North Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712408
- Sponsor's protocol ID
- IRB-21-629
- Status last verified
- Aug 2023
- First submitted
- 25 Jan 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silveira SL, Deemer SE, Synkowski E. Feasibility, Acceptability, and Preliminary Efficacy of an Online Diet Intervention for Promoting Fruit and Vegetable Intake Among Persons With Multiple Sclerosis. J Nutr Educ Behav. 2025 Oct;57(10):980-988. doi: 10.1016/j.jneb.2025.06.009. Epub 2025 Jul 12.
PubMed 40650650
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of an Online, Non-restrictive Diet Among Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05712408
- Acronym / sponsor ID
- IRB-21-629
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of North Texas, Denton, TXUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diet Intervention | Experimental | Behavioral: 800g Challenge8 week non-restrictive diet program |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- electronic medical implant, such as a heart pacemaker or an implantable cardioverter defibrillator (ICD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 800g ChallengeThe 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. | Behavioural | Diet Intervention |
Primary outcome
Metabolic Health
Time frame: From recruitment to end of 8 week intervention
Fasted Cholesterol and Gloucose
Body Weight
Time frame: From recruitment to end of 8 week intervention
Change in Body Weight
Body Fat
Time frame: From recruitment to end of 8 week intervention
Change in Body Fat Percentage
5 secondary outcomes
6-Minute Walk
Time frame: From recruitment to end of 8 week intervention
25-Foot Walk
Time frame: From recruitment to end of 8 week intervention
Cognitive Assessments
Time frame: From recruitment to end of 8 week intervention
Fatigue
Time frame: From recruitment to end of 8 week intervention
Health-Related Quality of Life
Time frame: From recruitment to end of 8 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 40650650Silveira SL, Deemer SE, Synkowski E. Feasibility, Acceptability, and Preliminary Efficacy of an Online Diet Intervention for Promoting Fruit and Vegetable Intake Among Persons With Multiple Sclerosis. J Nutr Educ Behav. 2025 Oct;57(10):980-988. doi: 10.1016/j.jneb.2025.06.009. Epub 2025 Jul 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Silveira principal investigator
University of North Texas Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 800g Challenge in people with Multiple Sclerosis, run by University of North Texas, Denton, TX at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Health (time frame: From recruitment to end of 8 week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05712408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.