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A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
    • History of eating disorder
    • Currently on a special diet for MS/other diet (provided diet will be pork free)
    • Chemotherapy within the past year

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Continuous calorie restriction

Intermittent calorie restriction

Control calorie intake

Arm Description

Participants will be provided with a diet that includes approximately 78% of calories each day that would be needed to maintain current BMI.

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.

Participants will be assigned to consume enough calories each day required to maintain current BMI

Outcomes

Primary Outcome Measures

Adverse events
Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.

Secondary Outcome Measures

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.
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.
Adverse Events
Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.
Quality of Life Questionnaire
"Functional Assessment in MS" results will be assessed during the study
NIH Patient-Reported-Outcomes Measurement Information System (PROMIS )Fatigue Questionnaire
PROMIS Fatigue results will be assessed during the study
Change in metabolite ratios
The impact of each calorie restriction diet versus control diet on the metabolomics profile will be assessed.
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.
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.
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.
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.
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.

Full Information

First Posted
December 28, 2015
Last Updated
November 14, 2017
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02647502
Brief Title
A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis
Official Title
A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous calorie restriction
Arm Type
Active Comparator
Arm Description
Participants will be provided with a diet that includes approximately 78% of calories each day that would be needed to maintain current BMI.
Arm Title
Intermittent calorie restriction
Arm Type
Experimental
Arm Description
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.
Arm Title
Control calorie intake
Arm Type
Placebo Comparator
Arm Description
Participants will be assigned to consume enough calories each day required to maintain current BMI
Intervention Type
Other
Intervention Name(s)
Diet
Intervention Description
Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.
Primary Outcome Measure Information:
Title
Adverse events
Description
Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Adherence to Calories Assigned
Description
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.
Time Frame
8 weeks
Title
Adherence to Calories Assigned
Description
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.
Time Frame
48 weeks
Title
Adverse Events
Description
Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.
Time Frame
48 weeks
Title
Quality of Life Questionnaire
Description
"Functional Assessment in MS" results will be assessed during the study
Time Frame
48 weeks
Title
NIH Patient-Reported-Outcomes Measurement Information System (PROMIS )Fatigue Questionnaire
Description
PROMIS Fatigue results will be assessed during the study
Time Frame
48 weeks
Title
Change in metabolite ratios
Description
The impact of each calorie restriction diet versus control diet on the metabolomics profile will be assessed.
Time Frame
8 weeks
Title
Immune cell subsets/cytokines
Description
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.
Time Frame
8 weeks
Title
Change in concentration of measures of metabolism
Description
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.
Time Frame
8 weeks
Title
Change in serum lipid concentration
Description
The impact of each calorie restriction diet versus control diet on fasting lipids and long-chain ceramides will be assessed.
Time Frame
8 weeks
Title
Change in serum brain-derived neurotrophic factor concentration (BDNF)
Description
The impact of each calorie restriction diet versus control diet on fasting BDNF will be assessed.
Time Frame
8 weeks
Title
Change in levels of oxidative stress biomarkers
Description
The impact of each calorie restriction diet versus control diet on protein carbonyls, 8-isoprostane, nitrotyrosine, and 4-hydroxynonenal adducts will be assessed.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 History of eating disorder Currently on a special diet for MS/other diet (provided diet will be pork free) Chemotherapy within the past year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Mowry, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis

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