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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 34 weeks
Awards & highlights

FOOD_for_MS Trial 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.Check my eligibility
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.See study design
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.

FOOD_for_MS Trial 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.

FOOD_for_MS Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Multiple Sclerosis
Secondary outcome measures
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 outcome measures
Anthropometric Measures: Height
Anthropometric Measures: Waist circumference
Anthropometric Measures: Weight
+14 more

FOOD_for_MS 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

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,562 Total Patients Enrolled
37 Trials studying Multiple Sclerosis
45,183 Patients Enrolled for Multiple Sclerosis
United States Department of DefenseFED
865 Previous Clinical Trials
327,599 Total Patients Enrolled
11 Trials studying Multiple Sclerosis
734 Patients Enrolled for Multiple Sclerosis
Washington University School of MedicineOTHER
1,937 Previous Clinical Trials
2,299,595 Total Patients Enrolled
15 Trials studying Multiple Sclerosis
52,182 Patients Enrolled for Multiple Sclerosis

Media Library

Calorie restriction (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05327322 — N/A
Multiple Sclerosis Research Study Groups: Low Glycemic Load, Standard Glycemic Load
Multiple Sclerosis Clinical Trial 2023: Calorie restriction Highlights & Side Effects. Trial Name: NCT05327322 — N/A
Calorie restriction (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05327322 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which patient demographic is most appropriate for participation in this trial?

"This medical trial is enrolment patients aged 18 to 65 with a Body Mass Index between 25 and 50 kg/m2, Expanded Disability Status Scale no greater than 6.5 (able to walk 100 metres with or without aid), not having received DMT in the prior six months, diagnosed with either Relapsing-Remitting MS or Secondary Progressive MS, stable on any Disease Modifying Treatment for the past half year and unlikely to adjust it within 34 weeks, as well as being responsible for food preparation or influencing this process."

Answered by AI

Are there any unfilled positions accessible to participants in this research?

"According to clinicaltrials.gov, this particular study is no longer taking partcipants; first posted on the 1st of January 2023 and recently updated on August 30th 2022. Nevertheless, there are still 554 other active trials currently recruiting patients."

Answered by AI

Does the eligibility for this research initiative encompass individuals aged seventy-five or above?

"This research project is inviting individuals aged 18 and over, but not yet 65 years of age, to participate."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Functional Outcomes From Diets in Multiple Sclerosis
Brooks C. Wingo, PhD 2023. "Functional Outcomes From Diets in Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05327322.
~62 spots leftby Jan 2026
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