Functional Outcomes From Diets in Multiple Sclerosis (FOOD_for_MS)

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Secondary Progressive Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis

Treatments: Behavioral: Glycemic load; Behavioral: Calorie restriction; Behavioral: Behavioral support

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05327322

CDMRP-MS210011 (Other Grant/Funding Number)

300009050

Details and patient eligibility

About

The purpose of this study is to test the effects of two dietary interventions, glycemic load and calorie restriction, on physical function, cognition, pain, fatigue, mood, and anxiety in adults with multiple sclerosis (MS). The investigators will also explore the how the diet interventions impact inflammation, immunity, and metabolic biomarkers.

Full description

100 participants will be randomized 1:1 to follow either a low glycemic load (GL) or standard GL diet for 32 weeks. For the first 16 weeks, all participants will eat enough calories to maintain their baseline weight. During the second 16 weeks, all participants will reduce calorie intake by 500kcal/day, with a goal of losing 5-10% of initial body weight. Participants will complete data collection at baseline (prior to randomization), at 17 weeks (after the weight stable phase) and again after completing the calorie restriction phase.

All participants will receive meal plans and groceries for the duration of the trial.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with RRMS or SPMS
• BMI 25-50 kg/m2 (overweight/obese)
• EDSS ≤6.5 (able to walk 100m with or without assistance)
• If on disease-modifying treatment (DMT), stable for 6 months
• If not on DMT, no DMT in previous 6 months
• No expected change to DMT in next 34 weeks
• Responsible for food preparation or have input into food preparation

Exclusion criteria

• MS relapse in previous 30 days
• Unable to walk 25 feet with or without assistive device
• Pregnant or breastfeeding
• Current use of insulin or sulfonylurea agents
• Score indicating low cognitive functioning on the Telephone Interview for Cognitive Status (TICS-m) assessment
• Actively engaged in a weight loss program or unwilling to follow assigned dietary pattern
• Unable to receive, store, or prepare food according to diet plan
• Medical contraindication to either treatment or control diet (including severe allergies that cannot be accommodated within either group)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Low Glycemic Load

Experimental group

Description:

This group will be prescribed a daily GL of <45 points/1000 kcal and 25% of daily calorie intake from carbohydrates. This group will be provided few processed foods. During the first 16 weeks, this group will eat enough calories to maintain baseline weight, and will reduce daily calorie intake by 500 kcal/day in the second 16 weeks.

Treatment:

Behavioral: Behavioral support

Behavioral: Calorie restriction

Behavioral: Glycemic load

Standard Glycemic Load

Active Comparator group

Description:

This group will be prescribed a daily GL of >75 points/1000kcal and 60% of daily calorie intake from carbohydrates. This group will be provided more processed foods than the low GL group. During the first 16 weeks, this group will eat enough calories to maintain baseline weight, and will reduce daily calorie intake by 500 kcal/day in the second 16 weeks.

Treatment:

Behavioral: Behavioral support

Behavioral: Calorie restriction

Behavioral: Glycemic load