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Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Functional Outcomes From Diets in Multiple Sclerosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosed with RRMS or SPMS.

- BMI 25-50 kg/m2 (overweight/obese) - EDSS ≤6.5 (able to walk 100m with or without assistance) - If on disease-modifying treatment (DMT), stable for 6 months.

- If not on DMT, no DMT in previous 6 months.

- No expected change to DMT in next 34 weeks.

- Responsible for food preparation or have input into food preparation.

Exclusion Criteria:

- MS relapse in previous 30 days.

- Unable to walk 25 feet with or without assistive device.

- Pregnant or breastfeeding.

- Current use of insulin or sulfonylurea agents.

- Score indicating low cognitive functioning on the Telephone Interview for Cognitive Status (TICS-m) assessment.

- Actively engaged in a weight loss program or unwilling to follow assigned dietary pattern.

- Unable to receive, store, or prepare food according to diet plan.

- Medical contraindication to either treatment or control diet (including severe allergies that cannot be accommodated within either group)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05327322
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Alabama at Birmingham
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Brooks Wingo, PhD
Principal Investigator Affiliation	University of Alabama at Birmingham
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, U.S. Fed
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis

Additional Details

100 participants will be randomized 1:1 to follow either a low glycemic load (GL) or standard GL diet for 32 weeks. For the first 16 weeks, all participants will eat enough calories to maintain their baseline weight. During the second 16 weeks, all participants will reduce calorie intake by 500kcal/day, with a goal of losing 5-10% of initial body weight. Participants will complete data collection at baseline (prior to randomization), at 17 weeks (after the weight stable phase) and again after completing the calorie restriction phase. All participants will receive meal plans and groceries for the duration of the trial.

Arms & Interventions

Arms

Experimental: Low Glycemic Load

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.

Active Comparator: Standard Glycemic Load

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.

Interventions

Behavioral: - Glycemic load

Participants will be provided food to meet GL prescription for the duration of the trial.

Behavioral: - Calorie restriction

Participants will be provided food to meet their prescribed daily calorie intake for the duration of the trial (weight stable in first 16 weeks, weight loss in second 16 weeks).

Behavioral: - Behavioral support

All participants will receive behavioral supports in the form of email, text, information pages and weekly calls from the study staff to maximize adherence.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Site Contact

Brooks C Wingo, PhD

[email protected]

205-934-5982

Washington University, Saint Louis, Missouri

Status