Functional Outcomes From Diets in Multiple Sclerosis

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

Running, not recruitingNot a drug-phase studyRelapsing and progressiveNCT05327322

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Glycemic load
  • Calorie restriction
  • Behavioral support

What it measured

Main measures

  • Multiple Sclerosis Functional Composite (MSFC)

    Baseline

    Disability progressionThinking and memory

  • Multiple Sclerosis Functional Composite (MSFC)

    17 weeks

    Disability progressionThinking and memory

  • Multiple Sclerosis Functional Composite (MSFC)

    34 weeks

    Disability progressionThinking and memory

Other measures (21)

  • Brief International Cognitive Assessment for MS (BICAMS)

    Baseline

    Thinking and memory

  • Brief International Cognitive Assessment for MS (BICAMS)

    17 weeks

    Thinking and memory

  • Brief International Cognitive Assessment for MS (BICAMS)

    34 weeks

    Thinking and memory

  • Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)

    Baseline

    Mood and sleepQuality of life (reported by participants)

  • Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)

    17 weeks

    Mood and sleepQuality of life (reported by participants)

  • Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)

    34 Weeks

    Mood and sleepQuality of life (reported by participants)

  • Patient reported outcomes: Modified Fatigue Impact Scale (MFIS)

    Baseline

    Thinking and memoryFatigueQuality of life (reported by participants)

  • Patient reported outcomes: Modified Fatigue Impact Scale (MFIS)

    17 weeks

    Thinking and memoryFatigueQuality of life (reported by participants)

  • Patient reported outcomes: Modified Fatigue Impact Scale (MFIS)

    34 Weeks

    Thinking and memoryFatigueQuality of life (reported by participants)

  • Patient reported outcomes: Fatigue Severity Scale (FSS)

    Baseline

    FatigueQuality of life (reported by participants)

Who could take part

Relapsing and progressive · 18 to 65

Show the full 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)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Mar 2023

    2. Main results due

      Nov 2026

    3. Finished

      Nov 2026

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