The Impact of Diet Quality and Calorie Restriction on Physical Function and Patient Reported Outcomes in Multiple Sclerosis

Diet quality and calorie restriction tested for MS physical function

NCT: NCT05327322 · Status: ACTIVE NOT RECRUITING · Phase: N/A · Sponsor: University of Alabama at Birmingham · Started: 2023-03-20 · Est. Completion: 2026-11-01

Plain English Summary

Functional Outcomes From Diets in Multiple Sclerosis is a Not Applicable clinical trial sponsored by University of Alabama at Birmingham studying Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis. This study tests if two diets, one low in sugar and one with fewer calories, can improve physical abilities and how patients feel in multiple sclerosis (MS). It is for adults diagnosed with relapsing or secondary progressive MS who are overweight or obese and can still walk. Participants will be randomly assigned to one of the two diets and receive food and support to follow it for 34 weeks. Alternatives include standard medical care and other lifestyle changes like exercise, but this study focuses specifically on diet's impact. The trial aims to enroll 100 participants.

Official Summary

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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you have relapsing or secondary progressive MS, a BMI between 25-50, and can walk at least 100 meters. You cannot join if you had an MS relapse recently, cannot walk 25 feet, are pregnant or breastfeeding, or have certain medical conditions or cognitive issues. Participants must be willing and able to prepare or have input into their food preparation. This trial is studying Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures, like the Multiple Sclerosis Functional Composite (MSFC), assess how well participants can perform key physical and neurological tasks, indicating improvements in daily fu The specific primary outcome measures are: Multiple Sclerosis Functional Composite (MSFC) (Baseline); Multiple Sclerosis Functional Composite (MSFC) (17 weeks); Multiple Sclerosis Functional Composite (MSFC) (34 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial addresses a gap in understanding how specific dietary changes can impact the physical function and overall well-being of individuals with multiple sclerosis. This research targets Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, where improved treatment options are needed.

Investor Insight

This trial signals a growing interest in lifestyle interventions for MS, a condition with a significant patient population, suggesting potential for non-pharmacological treatments and a competitive la

Is This Trial Right for Me?

Ask your doctor if these dietary changes are safe for you, especially if you have other health conditions. You will be assigned to either a low-glycemic load diet or a calorie-restricted diet and will receive all your food. The study involves regular check-ins and support via email, text, and phone calls to help you stick to your assigned diet for 34 weeks. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility 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 Locations

Frequently Asked Questions

What is clinical trial NCT05327322?

NCT05327322 is a Not Applicable INTERVENTIONAL study titled "Functional Outcomes From Diets in Multiple Sclerosis." It is currently active, not recruiting and is sponsored by University of Alabama at Birmingham. The trial targets enrollment of 100 participants.

What conditions does NCT05327322 study?

This trial investigates treatments for Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis. The primary condition under study is Relapsing Remitting Multiple Sclerosis.

What treatments are being tested in NCT05327322?

The interventions being studied include: Glycemic load (BEHAVIORAL), Calorie restriction (BEHAVIORAL), Behavioral support (BEHAVIORAL). Participants will be provided food to meet GL prescription for the duration of the trial.

What does Not Applicable mean for NCT05327322?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT05327322?

This trial is currently "Active, Not Recruiting." It started on 2023-03-20. The estimated completion date is 2026-11-01.

Who is sponsoring NCT05327322?

NCT05327322 is sponsored by University of Alabama at Birmingham. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT05327322?

The trial aims to enroll 100 participants. The trial status is active, not recruiting.

How is NCT05327322 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT05327322?

The primary outcome measures are: Multiple Sclerosis Functional Composite (MSFC) (Baseline); Multiple Sclerosis Functional Composite (MSFC) (17 weeks); Multiple Sclerosis Functional Composite (MSFC) (34 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT05327322 being conducted?

This trial is being conducted at 2 sites, including Birmingham, Alabama; St Louis, Missouri (United States).

Where can I find official information about NCT05327322?

The official record for NCT05327322 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05327322. This government database provides the most up-to-date and detailed information about the trial.

What is NCT05327322 testing in simple terms?

This study tests if two diets, one low in sugar and one with fewer calories, can improve physical abilities and how patients feel in multiple sclerosis (MS). It is for adults diagnosed with relapsing or secondary progressive MS who are overweight or obese and can still walk.

Why is this trial significant?

This trial addresses a gap in understanding how specific dietary changes can impact the physical function and overall well-being of individuals with multiple sclerosis.

What are the potential risks of participating in NCT05327322?

Potential side effects of calorie restriction could include fatigue, headaches, or nutrient deficiencies if not carefully managed. Following a strict diet can be challenging and may lead to feelings of deprivation or social isolation. Changes in blood sugar levels or digestive issues might occur with the glycemic load diet. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT05327322?

Ask your doctor if these dietary changes are safe for you, especially if you have other health conditions. You will be assigned to either a low-glycemic load diet or a calorie-restricted diet and will receive all your food. The study involves regular check-ins and support via email, text, and phone calls to help you stick to your assigned diet for 34 weeks. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT05327322 signal from an investment perspective?

This trial signals a growing interest in lifestyle interventions for MS, a condition with a significant patient population, suggesting potential for non-pharmacological treatments and a competitive la This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will be randomly assigned to one of the two diets and receive food and support to follow it for 34 weeks. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.