Diets + Behavioral Support for MS

(FOOD_for_MS Trial)

Recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two types of diets affect people with multiple sclerosis (MS), focusing on physical and mental health aspects such as pain, fatigue, mood, and anxiety. One group will follow a low glycemic load diet, which includes less sugar and processed foods, while the other will follow a standard glycemic load diet. Participants will also receive behavioral support, such as Cognitive Behavioral Therapy. Individuals diagnosed with specific types of MS, such as RRMS or SPMS, who manage their own food preparation, may be well-suited for this trial. As an unphased trial, this study provides a unique opportunity to contribute to understanding the impact of diet on MS.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both cutting calories and following a low glycemic load diet are generally safe for people with multiple sclerosis (MS). Early studies found these diets not only doable but also well-received by participants.

For the low glycemic load diet, studies suggest it is manageable for adults with MS and might even improve some health aspects. Although detailed information on side effects is limited, evidence so far indicates that serious issues are rare.

Overall, current research considers both diet plans safe for people with MS. However, as with any diet change, some individuals might experience mild side effects as their bodies adjust. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new dietary approach for managing multiple sclerosis (MS) because it focuses on calorie restriction and glycemic load, which are not typically part of standard MS treatments like immunomodulatory drugs. Unlike conventional therapies that target the immune system, this approach aims to reduce inflammation and improve symptoms by modifying diet. The Low Glycemic Load arm emphasizes fewer processed foods and a specific carbohydrate intake, which could lead to better blood sugar control and potentially fewer MS flare-ups. By incorporating behavioral support alongside dietary changes, this trial could offer a holistic, non-pharmaceutical option for managing MS.

What evidence suggests that this trial's dietary interventions could be effective for multiple sclerosis?

Research suggests that a diet with a low glycemic load may benefit people with multiple sclerosis (MS). In this trial, one group will follow a low glycemic load diet, which involves consuming fewer carbohydrates and processed foods, potentially enhancing physical abilities. Some studies have shown that individuals on this diet perform better on the timed 25-foot walk test, a common measure of mobility in MS patients. Another group in this trial will follow a standard glycemic load diet. Early trials indicated that reducing daily calorie intake can help manage MS symptoms. Both dietary changes are believed to reduce inflammation and boost metabolism. While more research is needed, these changes show promise for improving the lives of those with MS. ^{1 2 6 7 8}

Who Is on the Research Team?

Brooks Wingo, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38821260/

Functional outcomes of diets in multiple sclerosis (FOOD ... This 32-week, two-arm, RCT at two centers will randomly assign 100 adults with relapsing-remitting or secondary progressive MS to a low GL diet.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424001678

Functional outcomes of diets in multiple sclerosis (FOOD ... We hypothesize that a eucaloric low GL diet will lead to significantly greater improvements in physical function as measured by the timed 25-ft walk test (T25FW ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05327322

Functional Outcomes From Diets in Multiple Sclerosis The purpose of this study is to test the effects of two dietary interventions, glycemic load and calorie restriction, on physical function, cognition, pain, ...

4. profiles.wustl.edu profiles.wustl.edu/en/publications/functional-outcomes-of-diets-in-multiple-sclerosis-food-for-ms-pr

Functional outcomes of diets in multiple sclerosis (FOOD ... Background: Pilot trials indicate that both a low glycemic load (GL) diet and calorie restriction (CR) can be implemented successfully in people with multiple ...

5. trialx.com trialx.com/clinical-trials/listings/225599/functional-outcomes-from-diets-in-multiple-sclerosis/

Functional Outcomes From Diets in Multiple Sclerosis The purpose of this study is to test the effects of two dietary interventions, glycemic load and calorie restriction, on physical function, ...

6. clinicalkey.com clinicalkey.com/#!/content/journal/1-s2.0-S1551714424001678

Protocol for a parallel arm randomized feeding trial for low ... AbstractBackgroundPilot trials indicate that both a low glycemic load (GL) diet and calorie restriction (CR) can be implemented successfully in people with ...

7. sciencedirect.com sciencedirect.com/science/article/am/pii/S1551714424001678

Functional Outcomes of Diets in Multiple Sclerosis (FOOD ... Background: Pilot trials indicate that both a low glycemic load (GL) diet and calorie restriction (CR) can be implemented successfully in people with multiple ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034820305794

Feasibility of improving dietary quality using a telehealth ... Conclusion. A low GL dietary intervention is feasible for adults with RRMS and may lead to improvements in MS outcomes and cardiometabolic risk. Additional ...