Multiple SclerosisPhase 1MSNCT00852722
Low Fat Diet and Multiple Sclerosis
A Phase 1 study testing Low fat study diet in people with Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if following a specific low fat diet will improve the brain damage as seen by Magnetic Resonance Imaging (MRI) and to decrease the progression of multiple sclerosis (MS) as evidenced by clinical evaluation and symptoms. 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?
- Low fat study diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jul 2014
- Phase
- Phase 1
- 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
- Clinical diagnosis of the relapsing-remitting form of MS
- Age 18-70, inclusive
- MS duration of less than 15 years
- May or may not be on disease-modifying therapies for MS, but if on, must be on for more than 6 months of continuous therapy
- Should not have diabetes
- Able and willing to follow exercise instructions
- Able and willing to travel to California for 10-day training program (cost covered by study)
- Able and willing to travel to Portland, OR for 6 study visits over the 12 month study period (cost covered by study)
Who cannot join
- No clinically significant MS exacerbation within 30 days of screening visit
- No systemically administered corticosteroids within 30 days of study entry
- Patient not pregnant or breastfeeding
- Not taking fish oil/flax seed for at least 2 months prior to first visit
- No other significant health programs (e.g. active coronary heart disease, liver disease, pulmonary disease) that might increase risk of patient experiencing adverse events
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: A Randomized, Controlled Study of Diet and Multiple Sclerosis
The purpose of this study is to evaluate if following a specific low fat diet will improve the brain damage as seen by Magnetic Resonance Imaging (MRI) and to decrease the progression of multiple sclerosis (MS) as evidenced by clinical evaluation and symptoms.
Read the detailed description
This research project has significance for its potential to develop a new therapeutic approach to MS. Current treatments in MS include disease modifying therapies such as human recombinant interferon beta, glatiramer acetate and natalizumab. However, these are only partially effective, cannot be taken orally, have side-effects and are very expensive. Developing treatment that can be combined with current disease modifying agent remains an important goal for improving the care of people with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Low fat study diet
- Keywords
- Multiple sclerosis, Diet
- 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 study dietOther
The low fat study diet is a very low-saturated-fat, plant food based diet. It will be approximately 10% fat, 14% protein and 76% carbohydrate.The diet is is starched based and also contains fresh or frozen fruits and vegetables and there is no animal meat used, including no use of fish. This diet is very low in saturated fats and enriched in unsaturated fats. Subjects do not take dietary supplements.
| Study group | Role | What they receive |
|---|---|---|
| 1. Low fat study diet | Experimental | The low fat study diet arm will receive low fat diet training and followed for 12 months on the diet. Receives: Other: Low fat study diet |
| 2. Regular diet group | No intervention | The regular diet arm will be a wait-listed group that will receive no training in diet and will be advised to continue their regular (usual) diet as was prior to entry into the study, for the duration of the study. They will have a similar clinic follow up schedule as the treatment group. The regular diet group will be given identical instructions to exercise regularly similar to the treatment group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of new MS T2 lesion formation on brain MRI in those randomized to the low fat study diet with that of subjects randomized to follow their regular diet.
Measured: Baseline. Month 12.
Secondary outcomes (3)
To assess effects of the low fat study diet on clinical activity of MS as by relapse rate and disability progression and on fatigue, depression and quality of life.
Measured: Baseline. Month 3. Month 6. Month 9. Month 12.
To study the effects of the Low Fat Study Diet on serum markers of inflammation
Measured: Baseline. Month 6. Month 12.
To assess safety and tolerability of the low fat study diet upon 12 months of administration
Measured: Baseline. Month 3. Month 6. Month 9. Month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vijayshree Yadav, Oregon Health and Science University
- Investigators
- Vijayshree Yadav, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852722
- Sponsor's protocol ID
- OHSU IRB00004555
- Acronym
- MS
- Status last verified
- Feb 2015
- First submitted
- 26 Feb 2009
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study of Diet and Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00852722
- Acronym / sponsor ID
- MS / OHSU IRB00004555
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Diet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 27 Feb 2009 (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 study is to evaluate if following a specific low fat diet will improve the brain damage as seen by Magnetic Resonance Imaging (MRI) and to decrease the progression of multiple sclerosis (MS) as evidenced by clinical evaluation and symptoms.
Detailed description
This research project has significance for its potential to develop a new therapeutic approach to MS. Current treatments in MS include disease modifying therapies such as human recombinant interferon beta, glatiramer acetate and natalizumab. However, these are only partially effective, cannot be taken orally, have side-effects and are very expensive. Developing treatment that can be combined with current disease modifying agent remains an important goal for improving the care of people with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Low fat study diet | Experimental | Other: Low fat study dietThe low fat study diet arm will receive low fat diet training and followed for 12 months on the diet. |
| 2. Regular diet group | No intervention | –The regular diet arm will be a wait-listed group that will receive no training in diet and will be advised to continue their regular (usual) diet as was prior to entry into the study, for the duration of the study. They will have a similar clinic follow up schedule as the treatment group. The regular diet group will be given identical instructions to exercise regularly similar to the treatment group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of the relapsing-remitting form of MS
- Age 18-70, inclusive
- MS duration of less than 15 years
- May or may not be on disease-modifying therapies for MS, but if on, must be on for more than 6 months of continuous therapy
- Should not have diabetes
Key exclusion criteria (5 listed)
- No clinically significant MS exacerbation within 30 days of screening visit
- No systemically administered corticosteroids within 30 days of study entry
- Patient not pregnant or breastfeeding
- Not taking fish oil/flax seed for at least 2 months prior to first visit
- No other significant health programs (e.g. active coronary heart disease, liver disease, pulmonary disease) that might increase risk of patient experiencing adverse events
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 study dietThe low fat study diet is a very low-saturated-fat, plant food based diet. It will be approximately 10% fat, 14% protein and 76% carbohydrate.The diet is is starched based and also contains fresh or frozen fruits and vegetables and there is no animal meat used, including no use of fish. This diet is very low in saturated fats and enriched in unsaturated fats. Subjects do not take dietary supplements. | Other | 1. Low fat study diet |
Primary outcome
Number of new MS T2 lesion formation on brain MRI in those randomized to the low fat study diet with that of subjects randomized to follow their regular diet.
Time frame: Baseline. Month 12.
3 secondary outcomes
To assess effects of the low fat study diet on clinical activity of MS as by relapse rate and disability progression and on fatigue, depression and quality of life.
Time frame: Baseline. Month 3. Month 6. Month 9. Month 12.
To study the effects of the Low Fat Study Diet on serum markers of inflammation
Time frame: Baseline. Month 6. Month 12.
To assess safety and tolerability of the low fat study diet upon 12 months of administration
Time frame: Baseline. Month 3. Month 6. Month 9. Month 12.
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 4 Feb 2015.
- MS Center of OHSU websiteLink 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, MD 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 Phase 1 study testing Low fat study 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 8 inclusion and 5 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 4 Feb 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of new MS T2 lesion formation on brain MRI in those randomized to the low fat study diet with that of subjects randomized to follow their regular diet. (time frame: Baseline. Month 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2015.