A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title:

A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647502
• Other study ID #: IRB00065806
• Status: Completed
• Phase: N/A
• First received: December 28, 2015
• Last updated: November 14, 2017
• Start date: December 2015
• Est. completion date: June 2017

Study information

• Verified date: November 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Diet
Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	48 weeks
Secondary	Adverse Events	Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.	48 weeks
Secondary	Quality of Life Questionnaire	"Functional Assessment in MS" results will be assessed during the study	48 weeks
Secondary	NIH Patient-Reported-Outcomes Measurement Information System (PROMIS )Fatigue Questionnaire	PROMIS Fatigue results will be assessed during the study	48 weeks
Secondary	Change in metabolite ratios	The impact of each calorie restriction diet versus control diet on the metabolomics profile will be assessed.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks