Diets + Behavioral Support for MS
(FOOD_for_MS Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Must not be taking: Insulin, Sulfonylureas
Disqualifiers: MS relapse, Pregnancy, Low cognition, others
No Placebo Group
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.
12345Is 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.
12346How 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.
12347Eligibility 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.
+4 more
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.
+5 more
Trial 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
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Alabama at BirminghamBirmingham, AL
Washington UniversitySaint Louis, MO
Loading ...
Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
United States Department of DefenseCollaborator
Washington University School of MedicineCollaborator
References
Effect of intermittent vs. daily calorie restriction on changes in weight and patient-reported outcomes in people with multiple sclerosis. [2019]An intermittent fasting or calorie restriction diet has favorable effects in the mouse forms of multiple sclerosis (MS) and may provide additional anti-inflammatory and neuroprotective advantages beyond benefits obtained from weight loss alone. We conducted a pilot randomized controlled feeding study in 36 people with MS to assess safety and feasibility of different types of calorie restriction (CR) diets and assess their effects on weight and patient reported outcomes in people with MS. Patients were randomized to receive 1 of 3 diets for 8 weeks: daily CR diet (22% daily reduction in energy needs), intermittent CR diet (75% reduction in energy needs, 2 days/week; 0% reduction, 5 days/week), or a weight-stable diet (0% reduction in energy needs, 7 days/week). Of the 36 patients enrolled, 31 (86%) completed the trial; no significant adverse events occurred. Participants randomized to CR diets lost a median 3.4 kg (interquartile range [IQR]: -2.4, -4.0). Changes in weight did not differ significantly by type of CR diet, although participants randomized to daily CR tended to have greater weight loss (daily CR: -3.6 kg [IQR: -3.0, -4.1] vs. intermittent CR: -3.0 kg [IQR: -1.95, -4.1]; P = 0.15). Adherence to study diets differed significantly between intermittent CR vs. daily CR, with lesser adherence observed for intermittent CR (P = 0.002). Randomization to either CR diet was associated with significant improvements in emotional well-being/depression scores relative to control, with an average 8-week increase of 1.69 points (95% CI: 0.72, 2.66). CR diets are a safe/feasible way to achieve weight loss in people with MS and may be associated with improved emotional health.
Feasibility and acceptability of time-restricted eating in a group of adults with multiple sclerosis. [2023]Intermittent fasting (IF) has become a popular dietary pattern for adults with multiple sclerosis (MS), and initial studies in animal models and human trials indicate promising results for improving symptoms and slowing disease progression. Most studies published to date have focused on alternate day fasting or fasting mimicking diets including a 5:2 pattern, in which participants greatly restrict calorie intake on two non-consecutive days and eat regularly on other days; however, time restricted eating (TRE) may be equally effective for improving symptoms and may lead to better long term adherence due to its focus only on the time of day in which calories are consumed with no restriction on number of calories or types of food consumed.
Feasibility of improving dietary quality using a telehealth lifestyle intervention for adults with multiple sclerosis. [2021]Evidence from observational studies increasingly highlights the association between unhealthy diet and poor health outcomes in adults with multiple sclerosis (MS), but very few intervention trials for dietary change have been completed. Improving diet quality via a low glycemic load (GL) diet has demonstrated improvements in cardiometabolic risks, cognitive risks, and psychosocial variables in diseases other than MS. The purpose of this study was to test the feasibility of delivering a low GL dietary intervention implemented via telehealth in a sample of adults with relapsing remitting MS (RRMS). The secondary purpose was to explore the potential impact of the diet on MS outcomes and cardiometabolic risks.
Dietary Approaches to Treating Multiple Sclerosis-Related Symptoms. [2022]Although there is no dietary pattern than has been proven to be effective for reducing the number of relapses or enhancing lesions in patients with multiple sclerosis (MS), several pilot studies have demonstrated the efficacy of dietary plans to reduce MS-related symptoms. Low saturated fat (Swank), low fat vegan (McDougall), modified Paleolithic (Wahls), gluten free, Mediterranean, intermittent fasting, calorie restriction, and intermittent calorie restriction (fasting mimicking diet) all have been associated with reduction of MS-related symptoms such as reduced fatigue, improved mood, and improved quality of life. Mediterranean diet has proven effectiveness for prevention and reduction of comorbid disease severity.
Effects of dietary restriction on gut microbiota and CNS autoimmunity. [2023]Multiple sclerosis (MS) is the most common central nervous system (CNS) autoimmune disease. It is due to the interplay of genetic and environmental factors. Current opinion is that diet could play a pathogenic role in disease onset and development. Dietary restriction (DR) without malnutrition markedly improves health and increases lifespan in multiple model organisms. DR regimens that utilize continuous or intermittent food restriction can induce anti-inflammatory, immuno-modulatory and neuroendocrine adaptations promoting health. These adaptations exert neuroprotective effects in the main MS animal model, experimental autoimmune encephalomyelitis (EAE). This review summarizes the current knowledge on DR-induced changes in gut microbial composition and metabolite production and its impact on underlying functional mechanisms. Studies demonstrating the protective effects of DR regimens on EAE and people with MS are also presented. This is a rapidly developing research field with important clinical implications for personalized dietary interventions in MS prevention and treatment.
Pilot study of a ketogenic diet in relapsing-remitting MS. [2022]Label="Objective">To assess the safety and tolerability of a modified Atkins diet (KDMAD), a type of ketogenic diet (KD), in subjects with relapsing MS while exploring potential benefits of KDs in MS.
Desired Resources for Changing Diet Among Persons With Multiple Sclerosis: Qualitative Inquiry Informing Future Dietary Interventions. [2022]There are approximately 1 million adults in the United States with multiple sclerosis (MS). Persons with MS are interested in diet as a second-line therapy for improving MS symptoms and disease progression. Examination of desired resources regarding diet among persons with MS is necessary for supporting behavior change.