Multiple SclerosisNCT03322982
Low Fat Diet for Fatigue in MS
A study testing Low-fat diet in people with Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
Trial summary
A randomized, controlled pilot trial of a dietary intervention vs. wait-list control in patients with MS and fatigue for management of their fatigue. The hypothesis of this study is that participants following the low-fat study diet will demonstrate a significant reduction in fatigue after four months compared to wait… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Low-fat diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2018to 31 Mar 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70
- Diagnosis of MS by 2010 McDonald Criteria
- EDSS ≤ 7.5
- Experiencing moderate to severe fatigue (MFIS ≥ 38)
Who cannot join
- Current cardiopulmonary disease requiring treatment
- Diabetes
- Pregnancy or breast-feeding
- MS exacerbation within 30 days of screening visit
- IV steroids within 30 days of screening visit
- Dietary fat content of <30% as assessed by food frequency questionnaire (FFQ) at screening visit
- Fish oil or flax seed oil supplementation within 30 days of screening visit
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Oregon Health Science University
Portland, Oregon, 97239
Vijayshree Yadav
About this study
Official title: A Randomized, Controlled Trial of Low-fat Diet for Fatigue in Multiple Sclerosis
A randomized, controlled pilot trial of a dietary intervention vs. wait-list control in patients with MS and fatigue for management of their fatigue. The hypothesis of this study is that participants following the low-fat study diet will demonstrate a significant reduction in fatigue after four months compared to wait list controls.
- Conditions
- Multiple Sclerosis
- Being tested
- Low-fat diet
- Keywords
- diet, low-fat
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-fat dietBehavioural
less than 20% calories from fat daily
| Study group | Role | What they receive |
|---|---|---|
| MS Diet | Experimental | 34 people with MS following low-fat diet Receives: Behavioral: Low-fat diet |
| MS Wait-List | No intervention | 34 people with MS following usual diet |
| Diet Healthy Control | No intervention | 20 controls with no diagnosis of MS, age and sex-matched to members of the MS Diet group |
| Wait-List Healthy Control | No intervention | 20 controls with no diagnosis of MS, age and sex-matched to members of the MS Wait-List group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Measured by Modified Fatigue Impact Scale (MFIS). The MFIS is a 21-item questionnaire that assesses overall self-reported fatigue. Subjects rate agreement with a series of statements on a scale of 0 (rarely) to 4 (almost always), in context of their fatigue over the preceding four weeks. Total possible score of 84. Individuals with an MFIS score of > 38 are considered to experience moderate to severe "fatigue
Measured: Baseline to month 4
Secondary outcomes (2)
Fatigue
Measured by Fatigue Severity Scale (FSS). The FSS is a 9-item questionnaire, with subjects giving a response from 1-7 to indicate their degree of agreement with each statement.
Measured: Baseline to month 4
Disability
Measured by EDSS. The EDSS is an eight functional system scale including motor, sensory, cerebellar, brain stem, visual, mental, sphincteric, and other systems. Each functional system is graded from 0 (no disability) to 5 or 6 (maximal disability)20. An integrated score between 0 (normal examination) and 10 (death from MS) is formed based on the score in each functional system.
Measured: Baseline to month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start15 Aug 2018
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Vijayshree Yadav, Oregon Health and Science University
- Investigators
- Vijayshree Yadav, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322982
- Sponsor's protocol ID
- OHSU IRB16600
- Status last verified
- Feb 2021
- First submitted
- 24 Oct 2017
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chase E, Chen V, Martin K, Lane M, Wooliscroft L, Adams C, Rice J, Silbermann E, Hollen C, Fryman A, Purnell JQ, Vong C, Orban A, Horgan A, Khan A, Srikanth P, Yadav V. A low-fat diet improves fatigue in multiple sclerosis: Results from a randomized controlled trial. Mult Scler. 2023 Nov;29(13):1659-1675. doi: 10.1177/13524585231208330.
PubMed 37941305
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Low-fat Diet for Fatigue in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03322982
- Acronym / sponsor ID
- OHSU IRB16600
- Conditions
- Multiple Sclerosis
- Keywords
- diet, low-fat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 26 Oct 2017 (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.
A randomized, controlled pilot trial of a dietary intervention vs. wait-list control in patients with MS and fatigue for management of their fatigue. The hypothesis of this study is that participants following the low-fat study diet will demonstrate a significant reduction in fatigue after four months compared to wait list controls.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MS Diet | Experimental | Behavioral: Low-fat diet34 people with MS following low-fat diet |
| MS Wait-List | No intervention | –34 people with MS following usual diet |
| Diet Healthy Control | No intervention | –20 controls with no diagnosis of MS, age and sex-matched to members of the MS Diet group |
| Wait-List Healthy Control | No intervention | –20 controls with no diagnosis of MS, age and sex-matched to members of the MS Wait-List group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70
- Diagnosis of MS by 2010 McDonald Criteria
- EDSS ≤ 7.5
- Experiencing moderate to severe fatigue (MFIS ≥ 38)
Key exclusion criteria (7 listed)
- Current cardiopulmonary disease requiring treatment
- Diabetes
- Pregnancy or breast-feeding
- MS exacerbation within 30 days of screening visit
- IV steroids within 30 days of screening visit
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 |
|---|---|---|
| Low-fat dietless than 20% calories from fat daily | Behavioural | MS Diet |
Primary outcome
Fatigue
Time frame: Baseline to month 4
Measured by Modified Fatigue Impact Scale (MFIS). The MFIS is a 21-item questionnaire that assesses overall self-reported fatigue. Subjects rate agreement with a series of statements on a scale of 0 (rarely) to 4 (almost always), in context of their fatigue over the preceding four weeks. Total possible score of 84. Individuals with an MFIS score of > 38 are considered to experience moderate to severe "fatigue
2 secondary outcomes
Fatigue
Time frame: Baseline to month 4
Disability
Time frame: Baseline to month 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Derived from this study: PubMed 37941305Chase E, Chen V, Martin K, Lane M, Wooliscroft L, Adams C, Rice J, Silbermann E, Hollen C, Fryman A, Purnell JQ, Vong C, Orban A, Horgan A, Khan A, Srikanth P, Yadav V. A low-fat diet improves fatigue in multiple sclerosis: Results from a randomized controlled trial. Mult Scler. 2023 Nov;29(13):1659-1675. doi: 10.1177/13524585231208330.
- 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.
Vijayshree Yadav 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 Low-fat diet 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Orban (503-494-3549, orban@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: Baseline to month 4). 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 NCT03322982, 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 1 Mar 2021.