The effects of multimodal nutritional intervention in systemic scleroderma

The effects of multimodal nutritional intervention on gastrointestinal symptoms, physical performance, and modified rodnan skin score in patients with scleroderma: a randomized controlled trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220208053971N5

Enrollment

Registered

2024-11-18

Start date

2024-11-21

Completion date

Unknown

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

systemic scleroderma. Systemic sclerosis [scleroderma]

Interventions

Intervention 1: Intervention group: The type of intervention in the intervention group will include nutrition counseling, individual meal plan, receiving oral protein supplement. Nutrition counseling

In general, the amount of carbohydrates includes 55-60%, protein 15-20% and fat 25-30% of the total calories. Recommendations to increase protein intake, swallowing disorders, gastroesophageal reflux,

Eligibility

Sex/Gender

All

Age

30 Years to 65 Years

Inclusion criteria

Inclusion criteria: Diagnosis of systemic scleroderma by a physician Age between 30 and 65 years Diagnosis of malnutrition based on the GLIM criteria

Exclusion criteria

Exclusion criteria: Consumption of alcoholic beverages History of other autoimmune diseases History of kidney disease, pancreatitis, biliary disease, inflammatory bowel disease, celiac disease, cancer and neoplasia History of lower gastrointestinal diseases such as inflammatory bowel disease History of taking other multivitamin supplements in the last 3 months History of using other ONS in the last 3 months Changing the medication treatment protocol of patients in the last 3 months Pregnancy and lactation Patients following a specific diet

Design outcomes

Primary

Measure	Time frame
Gastrointestinal symptoms. Timepoint: Before the start of the intervention and 8 weeks after. Method of measurement: gastrointestinal symptoms with the help of UCLA SCTC GIT 2.0 questionnaire.;Physical performance. Timepoint: Before the start of the intervention and 8 weeks after. Method of measurement: physical performance with the help of 5STS , hand grip strength, 6MWD.;Modified rodnan skin score. Timepoint: Before the start of the intervention and 8 weeks after. Method of measurement: modified rodnan skin score with the help of MRSS document.	—

Measure

Time frame

Gastrointestinal symptoms. Timepoint: Before the start of the intervention and 8 weeks after. Method of measurement: gastrointestinal symptoms with the help of UCLA SCTC GIT 2.0 questionnaire.;Physical performance. Timepoint: Before the start of the intervention and 8 weeks after. Method of measurement: physical performance with the help of 5STS , hand grip strength, 6MWD.;Modified rodnan skin score. Timepoint: Before the start of the intervention and 8 weeks after. Method of measurement: modified rodnan skin score with the help of MRSS document.

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Secondary

Measure	Time frame
Body weight. Timepoint: Before the start of the intervention and 8 weeks after. Method of measurement: Digital scale.;Respiratory muscle strength. Timepoint: Before the start of the intervention and 8 weeks after. Method of measurement: With the Powerbreathe device and by measuring the PImax index.;Sleep quality. Timepoint: Before the start of the intervention and 8 weeks after. Method of measurement: PSQI.;Body mass index. Timepoint: Before the start of the intervention and 8 weeks after. Method of measurement: (from dividing weight (kilograms) by the square of height (meters)).	—

Measure

Time frame

Body weight. Timepoint: Before the start of the intervention and 8 weeks after. Method of measurement: Digital scale.;Respiratory muscle strength. Timepoint: Before the start of the intervention and 8 weeks after. Method of measurement: With the Powerbreathe device and by measuring the PImax index.;Sleep quality. Timepoint: Before the start of the intervention and 8 weeks after. Method of measurement: PSQI.;Body mass index. Timepoint: Before the start of the intervention and 8 weeks after. Method of measurement: (from dividing weight (kilograms) by the square of height (meters)).

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hamed Mohammadi

Tehran University of Medical Sciences

mohamadihd@gmail.com0098 21 889900285

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026