NCT05771207

Effects of Protein on Muscle, Gut Microbiota and Clinical Outcome in Patients With Lung Cancer-related Sarcopenia

Effects of Soy Protein and Whey Protein on Muscle, Gut Microbiota and Clinical Outcome in Patients With Lung Cancer-related Sarcopenia（LCRS）: a Randomized, Double-blind, Controlled Clinical Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Sarcopenia is common in lung cancer patients. It is one of the significant factors affecting the overall survival, radiotherapy and chemotherapy efficacy, and quality of life of patients with lung cancer. Previous studies have shown that increased protein intake can stimulate postprandial muscle synthesis, and improve muscle mass, strength, function, and overall survival. However, most previous studies have focused on the intervention of whey protein, while the protective effect of soybean protein on lung cancer-related sarcopenia (LCRS) has not yet been fully explored and reached an agreement. So, this study aims to explore the effects of soy and whey protein on muscle, gut microbiota, and clinical outcomes among patients with lung cancer-related sarcopenia, to provide a reference for further nutrition treatment.

Detailed description

This study will last 6 months. For the duration of the study, an anticipated total of 90 participants will be randomly assigned to receive either a 30-gram protein supplement or a placebo daily. There will be a total of 5 study visits, and dietary records, questionnaires, blood and stool collection, and functional testing will occur at all study visits. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be conducted in statistical analysis.

Conditions

• Lung Cancer
• Sarcopenia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	soy protein	The intervention is made up of soy protein supplements (30g/d) and dietary pattern modification.
DIETARY_SUPPLEMENT	whey protein	The intervention is made up of whey protein supplements (30g/d) and dietary pattern modification.
DIETARY_SUPPLEMENT	placebo	The intervention is made up of maltodextrin (30g/d) and dietary pattern modification.

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-10-01
• Completion: 2024-01-01
• First posted: 2023-03-16
• Last updated: 2023-03-16

Locations

1 site across 1 country: China