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

Effect of Whey Protein Supplementation Combined With Resistance Training on Muscle Mass in Patients With Intestinal Failure: A Randomized Controlled Trial

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07759271

Enrollment

Registered

2026-08-12

Start date

2026-08-28

Completion date

2027-10-28

Last updated

2026-08-12

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

Conditions

Intestinal Failure, Low Muscle Mass

Keywords

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

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.

Interventions

OTHERWhey Protein Supplementation Group

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

OTHERResistance Training Group

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Patients with chronic intestinal failure and low muscle mass. 2. Willing to participate in the study and provide written informed consent. 3. Able to complete the assigned 6-week intervention and the assessments at baseline, week 6, and week 8.

Exclusion criteria

1. Known allergy to whey protein. 2. Severe renal dysfunction.

Design outcomes

Primary

Measure	Time frame
Change in Appendicular Skeletal Muscle Mass Index	Baseline, Week 6, and Week 8

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026