Effects of multimodal nutritional intervention on nutritional status and clinical outcomes in patients with systemic sclerosis: study protocol for a randomised controlled trial.

Systemic sclerosis frequently results in malnutrition, which can decrease survival rates and physical performance while imposing financial burdens on healthcare systems and society.

• SSc is described as an autoimmune disorder causing progressive fibrosis of internal organs and skin, leading to increased thickness and rigidity.
• Malnutrition is identified as a common consequence of SSc with downstream effects on patient outcomes.
• Financial burden on healthcare systems and society is noted as a consequence of malnutrition in SSc patients.

The trial will enroll 46 qualified SSc participants randomised to receive multimodal nutritional intervention or dietary recommendations for 8 weeks.

• The study is designed as a parallel, randomised, placebo-controlled clinical trial.
• 46 participants will be randomly assigned to one of two arms: multimodal nutritional intervention or dietary recommendations (control).
• The intervention duration is 8 weeks.
• The trial is registered as IRCT20220208053971N4 and received ethics approval from the Medical Ethics Committee of Tehran University of Medical Sciences (IR.TUMS.MEDICINE.REC.1403.345).

The multimodal nutritional intervention encompasses multiple approaches including nutritional counselling, oral nutritional supplements, and disease-specific dietary regimens based on nutritional needs.

• Nutritional counselling is one component of the multimodal intervention.
• Consumption of oral nutritional supplements is included in the intervention.
• Disease-specific dietary regimens based on individual nutritional needs are part of the intervention design.
• The control arm receives dietary recommendations only.

The primary outcomes of the trial are changes in nutritional status and quality of life in SSc patients.

• Nutritional status is designated as a primary outcome measure.
• Quality of life is designated as a co-primary outcome measure.
• Statistical analysis will be conducted using SPSS software Version 24.

The secondary outcomes of the trial include changes in body composition, fatigue, body weight, body mass index, and calf circumference.

• Body composition is listed as a secondary outcome.
• Fatigue is listed as a secondary outcome.
• Body weight, body mass index, and calf circumference are also designated as secondary outcome measures.
• Food intake is additionally included among the outcomes to be assessed.