Clinical trial NCT05327322: Functional Outcomes From Diets in Multiple Sclerosis
Official title: The Impact of Diet Quality and Calorie Restriction on Physical Function and Patient Reported Outcomes in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Relapsing Remitting Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
name: United States Department of Defense
First posted: 2022-04-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to follow either a low GL or standard GL diet for 32 weeks. For the first 16 weeks, both groups will eat enough calories to maintain baseline weight. During the second 16 weeks, both groups will reduce calorie intake by 500 kcal/day,
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

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)

Primary outcomes:
measure: Multiple Sclerosis Functional Composite (MSFC)
timeFrame: Baseline
measure: Multiple Sclerosis Functional Composite (MSFC)
timeFrame: 17 weeks
measure: Multiple Sclerosis Functional Composite (MSFC)
timeFrame: 34 weeks
Secondary outcomes:
measure: Brief International Cognitive Assessment for MS (BICAMS)
timeFrame: Baseline
measure: Brief International Cognitive Assessment for MS (BICAMS)
timeFrame: 17 weeks
measure: Brief International Cognitive Assessment for MS (BICAMS)
timeFrame: 34 weeks
measure: Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline
measure: Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 17 weeks
measure: Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 34 Weeks
measure: Patient reported outcomes: Modified Fatigue Impact Scale (MFIS)
timeFrame: Baseline
measure: Patient reported outcomes: Modified Fatigue Impact Scale (MFIS)
timeFrame: 17 weeks
measure: Patient reported outcomes: Modified Fatigue Impact Scale (MFIS)
timeFrame: 34 Weeks
measure: Patient reported outcomes: Fatigue Severity Scale (FSS)
timeFrame: Baseline
measure: Patient reported outcomes: Fatigue Severity Scale (FSS)
timeFrame: 17 weeks
measure: Patient reported outcomes: Fatigue Severity Scale (FSS)
timeFrame: 34 Weeks
measure: Patient reported outcomes: Visual Analog Fatigue Scale (VAFS)
timeFrame: Baseline
measure: Patient reported outcomes: Visual Analog Fatigue Scale (VAFS)
timeFrame: 17 weeks
measure: Patient reported outcomes: Visual Analog Fatigue Scale (VAFS)
timeFrame: 34 Weeks
measure: Patient reported outcomes: Short-form McGill Pain Questionnaire Revised (SF-MPQ-2)
timeFrame: Baseline
measure: Patient reported outcomes: Short-form McGill Pain Questionnaire Revised (SF-MPQ-2)
timeFrame: 17 weeks
measure: Patient reported outcomes: Short-form McGill Pain Questionnaire Revised (SF-MPQ-2)
timeFrame: 34 Weeks
measure: Patient reported outcomes: Pittsburg Sleep Quality Index (PSQI)
timeFrame: Baseline
measure: Patient reported outcomes: Pittsburg Sleep Quality Index (PSQI)
timeFrame: 17 weeks
measure: Patient reported outcomes: Pittsburg Sleep Quality Index (PSQI)
timeFrame: 34 Weeks
Other outcomes:
measure: Blood work: glucose
timeFrame: Baseline
measure: Blood work: glucose
timeFrame: 17 weeks
measure: Blood work: glucose
timeFrame: 34 Weeks
measure: Blood work: insulin
timeFrame: Baseline
measure: Blood work: insulin
timeFrame: 17 weeks
measure: Blood work: insulin
timeFrame: 34 Weeks
measure: Blood work: lipids
timeFrame: Baseline
measure: Blood work: lipids
timeFrame: 17 weeks
measure: Blood work: lipids
timeFrame: 34 Weeks
measure: Blood work: TNF-a
timeFrame: Baseline
measure: Blood work: TNF-a
timeFrame: 17 weeks
measure: Blood work: TNF-a
timeFrame: 34 Weeks
measure: Blood work: IL-6
timeFrame: Baseline
measure: Blood work: IL-6
timeFrame: 17 weeks
measure: Blood work: IL-6
timeFrame: 34 Weeks
measure: Blood work: IL-17
timeFrame: Baseline
measure: Blood work: IL-17
timeFrame: 17 weeks
measure: Blood work: IL-17
timeFrame: 34 Weeks
measure: Blood work: adiponectin
timeFrame: Baseline
measure: Blood work: adiponectin
timeFrame: 17 weeks
measure: Blood work: adiponectin
timeFrame: 34 Weeks
measure: Blood work: leptin
timeFrame: Baseline
measure: Blood work: leptin
timeFrame: 17 weeks
measure: Blood work: leptin
timeFrame: 34 Weeks
measure: Blood work: T17
timeFrame: Baseline
measure: Blood work: T17
timeFrame: 17 weeks
measure: Blood work: T17
timeFrame: 34 Weeks
measure: Blood work: NFL
timeFrame: Baseline
measure: Blood work: NFL
timeFrame: 17 weeks
measure: Blood work: NFL
timeFrame: 34 Weeks
measure: Blood Pressure
timeFrame: Baseline
measure: Blood Pressure
timeFrame: 17 weeks
measure: Blood Pressure
timeFrame: 34 Weeks
measure: Anthropometric Measures: Weight
timeFrame: Baseline
measure: Anthropometric Measures: Weight
timeFrame: 17 weeks
measure: Anthropometric Measures: Weight
timeFrame: 34 Weeks
measure: Anthropometric Measures: Height
timeFrame: Baseline
measure: Anthropometric Measures: Height
timeFrame: 17 weeks
measure: Anthropometric Measures: Height
timeFrame: 34 weeks
measure: Anthropometric Measures: Waist circumference
timeFrame: Baseline
measure: Anthropometric Measures: Waist circumference
timeFrame: 17 weeks
measure: Anthropometric Measures: Waist circumference
timeFrame: 34 Weeks
measure: Total Body Composition
timeFrame: Baseline
measure: Total Body Composition
timeFrame: 17 weeks
measure: Total Body Composition
timeFrame: 34 Weeks
measure: Detailed body composition
timeFrame: Baseline
measure: Detailed body composition
timeFrame: 34 Weeks
measure: Neuroinflammation
timeFrame: Baseline
measure: Neuroinflammation
timeFrame: 34 Weeks
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: University of Alabama at Birmingham
name: Brooks Wingo, PhD
role: PRINCIPAL_INVESTIGATOR
References: