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Diets + Behavioral Support for MS (FOOD_for_MS Trial)

N/A

Recruiting

Led By Brooks Wingo, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

EDSS ≤6.5 (able to walk 100m with or without assistance)

Diagnosed with RRMS or SPMS

Must not have

Unable to walk 25 feet with or without assistive device

Current use of insulin or sulfonylurea agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 34 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether two different diets can help improve symptoms in people with MS.

Who is the study for?

This trial is for adults with multiple sclerosis (MS) who are overweight or obese, can walk at least 100m with assistance if needed, and have been stable on their current MS treatment for six months. They should be involved in food preparation and not planning to change their MS medication soon. Those who've had a recent MS relapse, cannot walk 25 feet, are pregnant or breastfeeding, use certain diabetes medications, show low cognitive function on TICS-m assessment, or cannot follow the diet plan due to medical reasons including severe allergies can't join.

What is being tested?

The study tests how two diets affect physical function, thinking skills, pain levels, fatigue mood and anxiety in people with MS. One diet focuses on lowering glycemic load while the other restricts calories. Participants will also receive behavioral support to help them stick to these diets. The effects of these diets on inflammation markers and metabolism will also be explored.

What are the potential side effects?

While specific side effects aren't listed for dietary interventions like these ones being tested in this trial; changes in diet may cause gastrointestinal discomfort such as bloating or constipation initially as well as possible changes in energy levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk 100 meters with or without help.

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I have been diagnosed with relapsing-remitting or secondary progressive MS.

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My BMI is between 25 and 50, indicating I am overweight or obese.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot walk 25 feet, even with help or a device.

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I am currently using insulin or sulfonylurea for my diabetes.

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I have had an MS flare-up in the last 30 days.

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I cannot follow a specific diet plan due to difficulties in getting, storing, or preparing food.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 34 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~34 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 34 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Multiple Sclerosis

Secondary study objectives

Brief International Cognitive Assessment for MS (BICAMS)

Patient reported outcomes: Fatigue Severity Scale (FSS)

Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)

+4 more

Other study objectives

Anthropometric Measures: Height

Anthropometric Measures: Waist circumference

Anthropometric Measures: Weight

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Low Glycemic LoadExperimental Treatment3 Interventions

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.

Group II: Standard Glycemic LoadActive Control3 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Calorie restriction

2014

N/A

~210

Behavioral support

2022

Completed Phase 4

~2290