Relapsing Remitting Multiple SclerosisNCT02647502
A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis
A study testing Diet in people with Relapsing Remitting Multiple Sclerosis, run by Johns Hopkins University at 1 site in United States.
Trial summary
Experimental studies of the experimental autoimmune encephalomyelitis (EAE), a mouse model of multiple sclerosis, indicate that the number of calories fed to mice prevent EAE and are also associated with less severe disease in mice who do develop the disease. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Jun 2017
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-50
- Capable of storing food safely, willing to follow diet/eat provided food, and able to receive shipments at home or work
- Meets 2010 criteria for McDonald MS;
- Relapse or new lesion in previous 2 years
- Expanded disability status score (EDSS) < 6
- Disease duration ≤15 years
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- Untreated or on stable on first-line MS therapy [injectable] for at least 6 months, with no anticipated changes in the next 10 weeks
- Unchanged vitamin D dose or thyroid replacement dose (for those on it) with no anticipated changes or in supplement use for the next 10 weeks.
- Non-regular smoker (average no more than 1 cigarette/day) for at least 2 months
- Stable weight, by self report, for past 3 months (± 8 lbs)
- Body mass index (BMI) > 23 kg/m2
Who cannot join
- Pregnant or nursing, or unwilling to prevent pregnancy (if of childbearing to potential)
- History of gastrointestinal disease causing malabsorption
- History of diabetes requiring medication
- History of stage IV/V chronic kidney disease or vascular disease
- History of major surgery in past 3 months
- Current use of warfarin
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- History of eating disorder
- Currently on a special diet for MS/other diet (provided diet will be pork free)
- Chemotherapy within the past year
Trial locations and contacts
1 site in 1 country.
About this study
Experimental studies of the experimental autoimmune encephalomyelitis (EAE), a mouse model of multiple sclerosis, indicate that the number of calories fed to mice prevent EAE and are also associated with less severe disease in mice who do develop the disease. Currently, whether these results translate favorably in humans is unknown. This is a pilot trial of testing two caloric restriction (CR) diets versus a control diet in multiple sclerosis (MS) patients: one continuous caloric restriction (CR) diet where a small number of calories will be restricted every day or another intermittent CR diet where a caloric intake will be restricted more severely 2 days per week. Participants are randomized to one of the diets, and for the first 8 weeks, will receive standardized, prepared meals tailored to the specific diet. At the conclusion of the controlled feeding study, all participants will transition to an unblinded phase for an additional 40 weeks where they are provided with instructions to follow an intermittent CR diet.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Diet
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.
| Study group | Role | What they receive |
|---|---|---|
| Continuous calorie restriction | Active comparator | Participants will be provided with a diet that includes approximately 78% of calories each day that would be needed to maintain current BMI. Receives: Other: Diet |
| Intermittent calorie restriction | Experimental | Participants will be provided a diet that with a daily calorie intake required to maintain current BMI, except only 25% of this calorie intake will be provided for 2 days a week. Receives: Other: Diet |
| Control calorie intake | Placebo comparator | Participants will be assigned to consume enough calories each day required to maintain current BMI Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.
Measured: 8 weeks
Secondary outcomes (11)
Adherence to Calories Assigned
Adherence will be assessed by comparing the total caloric intake provided to the patients through the assigned diet to the total energy intake determined by the research dieticians.
Measured: 8 weeks
Adherence to Calories Assigned
Adherence during the "advice-only" phase will be compared to adherence in each diet group during the first 8 weeks using paired t-tests, where the grouping is done naturally by subject.
Measured: 48 weeks
Adverse Events
Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.
Measured: 48 weeks
Quality of Life Questionnaire
"Functional Assessment in MS" results will be assessed during the study
Measured: 48 weeks
NIH Patient-Reported-Outcomes Measurement Information System (PROMIS )Fatigue Questionnaire
PROMIS Fatigue results will be assessed during the study
Measured: 48 weeks
Change in metabolite ratios
The impact of each calorie restriction diet versus control diet on the metabolomics profile will be assessed.
Measured: 8 weeks
Immune cell subsets/cytokines
The impact of each calorie restriction diet versus control diet on ratios of immune cell subsets (e.g. T-helper (TH)17, TH1, TH2, T regulatory) and related cytokines will be assessed.
Measured: 8 weeks
Change in concentration of measures of metabolism
The impact of each calorie restriction diet versus control diet on fasting glucose, insulin, leptin, ghrelin, C-reactive protein, lipids, and long-chain ceramides will be assessed.
Measured: 8 weeks
Change in serum lipid concentration
The impact of each calorie restriction diet versus control diet on fasting lipids and long-chain ceramides will be assessed.
Measured: 8 weeks
Change in serum brain-derived neurotrophic factor concentration (BDNF)
The impact of each calorie restriction diet versus control diet on fasting BDNF will be assessed.
Measured: 8 weeks
Change in levels of oxidative stress biomarkers
The impact of each calorie restriction diet versus control diet on protein carbonyls, 8-isoprostane, nitrotyrosine, and 4-hydroxynonenal adducts will be assessed.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen M. Mowry, Johns Hopkins University
- Investigators
- Ellen Mowry, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647502
- Sponsor's protocol ID
- IRB00065806
- Status last verified
- Nov 2017
- First submitted
- 28 Dec 2015
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02647502
- Acronym / sponsor ID
- IRB00065806
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 6 Jan 2016 (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.
Experimental studies of the experimental autoimmune encephalomyelitis (EAE), a mouse model of multiple sclerosis, indicate that the number of calories fed to mice prevent EAE and are also associated with less severe disease in mice who do develop the disease. Currently, whether these results translate favorably in humans is unknown. This is a pilot trial of testing two caloric restriction (CR) diets versus a control diet in multiple sclerosis (MS) patients: one continuous caloric restriction (CR) diet where a small number of calories will be restricted every day or another intermittent CR diet where a caloric intake will be restricted more severely 2 days per week. Participants are randomized to one of the diets, and for the first 8 weeks, will receive standardized, prepared meals tailored to the specific diet. At the conclusion of the controlled feeding study, all participants will transition to an unblinded phase for an additional 40 weeks where they are provided with instructions to follow an intermittent CR diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous calorie restriction | Active comparator | Other: DietParticipants will be provided with a diet that includes approximately 78% of calories each day that would be needed to maintain current BMI. |
| Intermittent calorie restriction | Experimental | Other: DietParticipants will be provided a diet that with a daily calorie intake required to maintain current BMI, except only 25% of this calorie intake will be provided for 2 days a week. |
| Control calorie intake | Placebo comparator | Other: DietParticipants will be assigned to consume enough calories each day required to maintain current BMI |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Aged 18-50
- Capable of storing food safely, willing to follow diet/eat provided food, and able to receive shipments at home or work
- Meets 2010 criteria for McDonald MS;
- Relapse or new lesion in previous 2 years
- Expanded disability status score (EDSS) < 6
Key exclusion criteria (9 listed)
- Pregnant or nursing, or unwilling to prevent pregnancy (if of childbearing to potential)
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 |
|---|---|---|
| DietDiet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described. | Other | Continuous calorie restriction, Control calorie intake, Intermittent calorie restriction |
Primary outcome
Adverse events
Time frame: 8 weeks
Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.
11 secondary outcomes
Adherence to Calories Assigned
Time frame: 8 weeks
Adherence to Calories Assigned
Time frame: 48 weeks
Adverse Events
Time frame: 48 weeks
Quality of Life Questionnaire
Time frame: 48 weeks
NIH Patient-Reported-Outcomes Measurement Information System (PROMIS )Fatigue Questionnaire
Time frame: 48 weeks
Change in metabolite ratios
Time frame: 8 weeks
Immune cell subsets/cytokines
Time frame: 8 weeks
Change in concentration of measures of metabolism
Time frame: 8 weeks
Change in serum lipid concentration
Time frame: 8 weeks
Change in serum brain-derived neurotrophic factor concentration (BDNF)
Time frame: 8 weeks
Change in levels of oxidative stress biomarkers
Time frame: 8 weeks
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 17 Nov 2017.
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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.
Ellen Mowry, MD principal investigator
Johns Hopkins 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 Diet in people with Relapsing Remitting Multiple Sclerosis, run by Johns Hopkins 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 11 inclusion and 9 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 17 Nov 2017. 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. Some participants in this study may receive a placebo. 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?
Adverse events (time frame: 8 weeks). 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 17 Nov 2017.