A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis

NCT02647502 | Completed DMC

• 1 other identifier: IRB00065806
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Adherence to Calories Assigned

  8 weeks

• Adherence to Calories Assigned

  48 weeks

• Adverse Events

  48 weeks

• Quality of Life Questionnaire

  48 weeks

• NIH Patient-Reported-Outcomes Measurement Information System (PROMIS )Fatigue Questionnaire

  48 weeks

Study Arms (3)

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.

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.

Other: Diet

Control calorie intake

PLACEBO COMPARATOR

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

Other: Diet

Interventions

Diet OTHER

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

Continuous calorie restriction; Control calorie intake; Intermittent calorie restriction

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Diet

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Ellen Mowry, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology and Epidemiology

Study Record Dates

• First Submitted: December 28, 2015
• First Posted: January 6, 2016
• Study Start: December 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

US (1)