Multiple SclerosisNCT02424825
Rouxbe Pilot for MS
A study testing Cooking Course in people with Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this protocol is to collect data from approximately 15 multiple sclerosis (MS) patients who are participating in a pilot cooking course. This online cooking training program is currently available to general public through the company "Rouxbe" for a fee. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Cooking Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to May 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of MS
- Willingness to comply with the diet and values set forth in the course
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University Multiple Sclerosis Center.
Portland, Oregon, 97239
About this study
Official title: A Low-fat, Plant-based Cooking Course for Patients With Multiple Sclerosis
The purpose of this protocol is to collect data from approximately 15 multiple sclerosis (MS) patients who are participating in a pilot cooking course. This online cooking training program is currently available to general public through the company "Rouxbe" for a fee. Data gathered from this cooking course will be used to develop novel ways of promoting healthy eating habits in people with MS. The investigators will use the data from blood tests, questionnaires, and demographics to assess the feasibility and effectiveness of this program. This is an outpatient program designed for people with MS that would occur regardless of whether participant data is collected.
This pilot cooking course will run for approximately four weeks. The investigators intend start to the training course in mid-March 2015. Subjects will be followed prior to course initiation for baseline data gathering, at four weeks from baseline, twelve weeks from baseline, and twenty-four weeks from baseline.
- Conditions
- Multiple Sclerosis
- Being tested
- Cooking Course
- Keywords
- diet, cooking, multiple sclerosis, fatigue
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooking CourseBehavioural
This is a month-long online cooking course, aimed at promoting a low-fat, plant-based diet.
| Study group | Role | What they receive |
|---|---|---|
| Rouxbe | Experimental | Subjects will attend a one-month online cooking course, and be followed before, during, and after their participation for quality-of-life, fatigue, and blood biomarker changes. Receives: Behavioral: Cooking Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Feasibility and Efficacy (composite of student perception, learning, and adherence by surveys)
We will measure feasibility as a composite of student perception, learning, and adherence by administering Opening and Closing Surveys (to evaluate student perception of course), a Final Assessment (to evaluate student learning), and the NutritionQuest Block Food Frequency Questionnaire (to evaluate adherence to low-fat, plant-based lifestyle).
Measured: 6 months
Secondary outcomes (4)
Weight Change measured by body weight, body mass index, waist circumference
Measured: 6 months
Diet Change measured by NutritionQuest Block Food Frequency Questionnaire, Opening Survey, Program Evaluation Survey
Measured: 6 months
Program Evaluation through Program Evaluation Survey
Measured: 6 months
Fatigue measured by Modified Fatigue Impact Scale-5 and Fatigue Severity Scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2015
- Study completionMay 2015
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.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Rouxbe Cooking School
- Responsible party
- Principal investigator, Vijayshree Yadav, Oregon Health and Science University
- Investigators
- Vijayshree Yadav, MBBs, MCR, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424825
- Sponsor's protocol ID
- IRB00011383
- Status last verified
- Apr 2019
- First submitted
- 9 Feb 2015
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Perlman J, Wu H, Fryman A, Lane M, Bittner F, Sammi MK, Rooney WD, Stevens A, Yadav V. Effects of vascular disease risk factors on brain metabolism in multiple sclerosis. Mult Scler Relat Disord. 2025 Dec;104:106700. doi: 10.1016/j.msard.2025.106700. Epub 2025 Sep 10.
PubMed 40976206
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Low-fat, Plant-based Cooking Course for Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02424825
- Acronym / sponsor ID
- IRB00011383
- Conditions
- Multiple Sclerosis
- Keywords
- diet, cooking, multiple sclerosis, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Rouxbe Cooking School
- Study start
- Feb 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 Apr 2015 (estimated)
- 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 purpose of this protocol is to collect data from approximately 15 multiple sclerosis (MS) patients who are participating in a pilot cooking course. This online cooking training program is currently available to general public through the company "Rouxbe" for a fee. Data gathered from this cooking course will be used to develop novel ways of promoting healthy eating habits in people with MS. The investigators will use the data from blood tests, questionnaires, and demographics to assess the feasibility and effectiveness of this program. This is an outpatient program designed for people with MS that would occur regardless of whether participant data is collected.
This pilot cooking course will run for approximately four weeks. The investigators intend start to the training course in mid-March 2015. Subjects will be followed prior to course initiation for baseline data gathering, at four weeks from baseline, twelve weeks from baseline, and twenty-four weeks from baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rouxbe | Experimental | Behavioral: Cooking CourseSubjects will attend a one-month online cooking course, and be followed before, during, and after their participation for quality-of-life, fatigue, and blood biomarker changes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of MS
- Willingness to comply with the diet and values set forth in the course
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cooking CourseThis is a month-long online cooking course, aimed at promoting a low-fat, plant-based diet. | Behavioural | Rouxbe |
Primary outcome
Program Feasibility and Efficacy (composite of student perception, learning, and adherence by surveys)
Time frame: 6 months
We will measure feasibility as a composite of student perception, learning, and adherence by administering Opening and Closing Surveys (to evaluate student perception of course), a Final Assessment (to evaluate student learning), and the NutritionQuest Block Food Frequency Questionnaire (to evaluate adherence to low-fat, plant-based lifestyle).
4 secondary outcomes
Weight Change measured by body weight, body mass index, waist circumference
Time frame: 6 months
Diet Change measured by NutritionQuest Block Food Frequency Questionnaire, Opening Survey, Program Evaluation Survey
Time frame: 6 months
Program Evaluation through Program Evaluation Survey
Time frame: 6 months
Fatigue measured by Modified Fatigue Impact Scale-5 and Fatigue Severity Scale
Time frame: 6 months
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 29 Apr 2019.
- Derived from this study: PubMed 40976206Perlman J, Wu H, Fryman A, Lane M, Bittner F, Sammi MK, Rooney WD, Stevens A, Yadav V. Effects of vascular disease risk factors on brain metabolism in multiple sclerosis. Mult Scler Relat Disord. 2025 Dec;104:106700. doi: 10.1016/j.msard.2025.106700. Epub 2025 Sep 10.
- Rouxbe Cooking SchoolLink provided by the sponsor.
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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.
Vijayshree Yadav, MBBs, MCR principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooking Course in people with Multiple Sclerosis, run by Oregon Health and Science University 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 2 inclusion and 0 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 29 Apr 2019. 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?
Program Feasibility and Efficacy (composite of student perception, learning, and adherence by surveys) (time frame: 6 months). 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 NCT02424825, 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 29 Apr 2019.