Diets + Behavioral Support for MS

(FOOD_for_MS Trial)

Recruiting at 1 trial location

Overseen By Brooks C Wingo, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Insulin, Sulfonylureas

Disqualifiers: MS relapse, Pregnancy, Low cognition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that if you are on disease-modifying treatment (DMT), it must be stable for 6 months. If you are not on DMT, you should not have taken any in the previous 6 months.

What data supports the effectiveness of the treatment Diets + Behavioral Support for MS?

Research shows that calorie restriction diets, including intermittent fasting, can lead to weight loss and improved emotional well-being in people with MS. Additionally, dietary changes like low glycemic load diets have shown benefits in reducing symptoms and improving quality of life in MS and other conditions. ^{1 2 3 4 5}

Is the combination of diets and behavioral support safe for people with multiple sclerosis?

Research indicates that calorie restriction diets, including intermittent fasting, are generally safe for people with multiple sclerosis, with no significant adverse events reported in studies. These diets may also improve emotional well-being and are feasible for weight loss. ^{1 2 3 4 6}

How does the Diets + Behavioral Support for MS treatment differ from other treatments for multiple sclerosis?

This treatment is unique because it combines calorie restriction and low glycemic load diets, which have shown potential benefits in reducing MS-related symptoms like fatigue and improving emotional well-being. Unlike standard drug treatments, this approach focuses on dietary changes and behavioral support to manage symptoms and improve quality of life. ^{1 2 3 4 7}

Research Team

Brooks Wingo, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Inclusion Criteria

Responsible for food preparation or have input into food preparation

No expected change to DMT in next 34 weeks

I have been on a stable treatment plan for my condition for the last 6 months.

Exclusion Criteria

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

Pregnant or breastfeeding

I am currently using insulin or sulfonylurea for my diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline data collection prior to randomization

1 week

1 visit (in-person)

Weight Stable Phase

Participants follow either a low or standard glycemic load diet while maintaining baseline weight

16 weeks

1 visit (in-person) at 17 weeks

Calorie Restriction Phase

Participants reduce calorie intake by 500 kcal/day with a goal of losing 5-10% of initial body weight

16 weeks

1 visit (in-person) at 34 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Behavioral support
• Calorie restriction
• Glycemic load

Trial Overview 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.

Participant Groups

Group I: Low Glycemic Load Experimental Treatment 3 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 Load Active Control 3 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Findings from Research

A pilot study involving 36 people with multiple sclerosis (MS) found that calorie restriction (CR) diets are safe and feasible, with 86% of participants completing the 8-week trial without significant adverse events.

Participants on CR diets experienced a median weight loss of 3.4 kg and reported significant improvements in emotional well-being and depression scores compared to those on a weight-stable diet, suggesting potential mental health benefits beyond weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intermittent vs. daily calorie restriction on changes in weight and patient-reported outcomes in people with multiple sclerosis. Fitzgerald, KC., Vizthum, D., Henry-Barron, B., et al.[2019]

A pilot study involving 12 adults with relapsing remitting multiple sclerosis (RRMS) found that time-restricted eating (TRE) was feasible and well-accepted, with a high retention rate of 92%.

Initial exploratory results suggest that TRE may positively impact symptoms like cognition, pain, and fatigue, indicating the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of time-restricted eating in a group of adults with multiple sclerosis. Wingo, BC., Rinker, JR., Green, K., et al.[2023]

A low glycemic load (GL) dietary intervention delivered via telehealth was feasible for adults with relapsing remitting multiple sclerosis (RRMS), with 90% of participants completing the study and showing high adherence to the diet.

Participants experienced positive changes in health outcomes, including a mean weight loss of 2.93 kg and improvements in anxiety, pain, and emotional health, suggesting that dietary changes may benefit both MS symptoms and cardiometabolic risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of improving dietary quality using a telehealth lifestyle intervention for adults with multiple sclerosis. Wingo, BC., Rinker, JR., Goss, AM., et al.[2021]

While no specific diet has been definitively proven to prevent relapses or lesions in multiple sclerosis (MS) patients, various dietary plans have shown promise in alleviating MS-related symptoms, such as fatigue and mood improvement.

Diets like the Mediterranean diet not only help with MS symptoms but also effectively prevent and reduce the severity of related health issues, highlighting their potential benefits for overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Approaches to Treating Multiple Sclerosis-Related Symptoms. Wahls, TL.[2022]

Dietary restriction (DR) has been shown to improve health and increase lifespan in various model organisms, and it may also have protective effects in multiple sclerosis (MS) by inducing anti-inflammatory and neuroprotective adaptations.

Research indicates that DR can alter gut microbial composition and metabolite production, which could play a significant role in the prevention and treatment of MS, highlighting the potential for personalized dietary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of dietary restriction on gut microbiota and CNS autoimmunity. Cantoni, C., Dorsett, Y., Fontana, L., et al.[2023]

The modified Atkins diet (KDMAD) is safe and well-tolerated in individuals with relapsing multiple sclerosis (MS), with no subjects experiencing worsening of their condition during the 6-month study involving 20 participants.

KDMAD led to significant improvements in fatigue and depression scores, as well as reductions in body mass index and total fat mass, indicating potential benefits for managing symptoms of MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a ketogenic diet in relapsing-remitting MS. Brenton, JN., Banwell, B., Bergqvist, AGC., et al.[2022]

Adults with multiple sclerosis (MS) expressed a strong interest in dietary changes as a way to improve their symptoms and disease progression, highlighting the need for clear, MS-specific dietary information.

The study identified four key themes for dietary behavior change: the need for evidence on diet's impact on MS, reliable dietary guidelines from professionals, behavioral support for making changes, and practical resources like recipes and meal services, which can help facilitate these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Desired Resources for Changing Diet Among Persons With Multiple Sclerosis: Qualitative Inquiry Informing Future Dietary Interventions. Silveira, SL., Richardson, EV., Motl, RW.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of intermittent vs. daily calorie restriction on changes in weight and patient-reported outcomes in people with multiple sclerosis. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of time-restricted eating in a group of adults with multiple sclerosis. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of improving dietary quality using a telehealth lifestyle intervention for adults with multiple sclerosis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Dietary Approaches to Treating Multiple Sclerosis-Related Symptoms. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of dietary restriction on gut microbiota and CNS autoimmunity. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Pilot study of a ketogenic diet in relapsing-remitting MS. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Desired Resources for Changing Diet Among Persons With Multiple Sclerosis: Qualitative Inquiry Informing Future Dietary Interventions. [2022]