Effects of Whey Protein and Resistance Training on Muscle Mass in Patients With Intestinal Failure

NCT07759271 | Not Yet Recruiting

• 1 other identifier: 2026DZKY-134-01
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

This single-center, prospective, four-arm randomized controlled trial will enroll 72 adults with chronic intestinal failure and low muscle mass. All participants will receive standardized basic nutritional support and will be randomly assigned to one of four groups: usual care, whey protein supplementation, resistance training, or whey protein supplementation combined with resistance training. Participants assigned to whey protein supplementation will receive 20 g of whey protein daily for 6 weeks. Participants assigned to resistance training will complete moderate-intensity resistance exercises for approximately 30 minutes, 3 to 5 times per week, for 6 weeks. Participants in the combined group will receive both interventions. Body composition, appendicular skeletal muscle mass index, phase angle, handgrip strength, 6-meter walking speed, laboratory indicators, and quality of life will be assessed at baseline, week 6, and week 8. The study aims to evaluate the effectiveness and safety of whey protein supplementation and resistance training, alone or in combination, for improving muscle mass and physical function in patients with chronic intestinal failure.

Conditions

Intestinal Failure; Low Muscle Mass

Keywords

Chronic Intestinal Failure; Low Muscle Mass; Resistance Training; Appendicular Skeletal Muscle Mass Index; Physical Function

Outcome Measures

Primary Outcomes (1)

• Change in Appendicular Skeletal Muscle Mass Index

  Baseline, Week 6, and Week 8

Study Arms (4)

Control Group

NO INTERVENTION

Participants will receive standardized basic nutritional support and usual clinical care without additional whey protein supplementation or protocol-specified resistance training.

Resistance Training Group

EXPERIMENTAL

Participants will receive standardized basic nutritional support and moderate-intensity resistance training for approximately 30 minutes per session, 3 to 5 times per week, for 6 weeks.

Other: Resistance Training Group

Combined Intervention Group

EXPERIMENTAL

Participants will receive standardized basic nutritional support, 20 g of whey protein orally once daily, and moderate-intensity resistance training for approximately 30 minutes per session, 3 to 5 times per week, for 6 weeks.

Other: Whey Protein Supplementation Group; Other: Resistance Training Group

Whey Protein Supplementation Group

EXPERIMENTAL

Other: Whey Protein Supplementation Group

Interventions

Whey Protein Supplementation Group OTHER

Participants will receive standardized basic nutritional support and 20 g of whey protein orally once daily for 6 weeks.

Combined Intervention Group; Whey Protein Supplementation Group

Resistance Training Group OTHER

Participants will perform moderate-intensity resistance training for approximately 30 minutes per session, 3 to 5 times per week, for 6 weeks, in addition to standardized basic nutritional support.

Combined Intervention Group; Resistance Training Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic intestinal failure and low muscle mass.
• Willing to participate in the study and provide written informed consent.
• Able to complete the assigned 6-week intervention and the assessments at baseline, week 6, and week 8.

You may not qualify if:

• Known allergy to whey protein.
• Severe renal dysfunction.

Sponsors & Collaborators

• Wang Xinying: lead

MeSH Terms

Conditions

Intestinal Failure

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This is a four-arm, parallel-group randomized controlled trial evaluating whey protein supplementation and resistance training, each alone and in combination, compared with usual care.

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): August 28, 2026
• Primary Completion (Estimated): August 28, 2027
• Study Completion (Estimated): October 28, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08