ClinicalTrials.gg
Not yet recruitingNCT07759271Updated Aug 12, 2026

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

An interventional study of Whey Protein Supplementation Group and Resistance Training Group in Intestinal Failure and Low Muscle Mass, sponsored by Wang Xinying. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Wang Xinying · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Intestinal Failure
  • Low Muscle Mass

Browse trials for

Keywords

  • Chronic Intestinal Failure
  • Low Muscle Mass
  • Resistance Training
  • Appendicular Skeletal Muscle Mass Index
  • Physical Function
03

In context

Intestinal Failure

64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.

This study's planned enrollment of 72 is above the median of 38 across 42 interventional studies indexed under Intestinal Failure.

Browse Intestinal Failure studies →

Lead sponsor

Wang Xinying is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Known allergy to whey protein.
  2. Severe renal dysfunction.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • No intervention
    Control Group

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

  • Experimental
    Resistance Training Group

    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

  • Experimental
    Combined Intervention Group

    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

  • Experimental
    Whey Protein Supplementation Group

    Other: Whey Protein Supplementation Group

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.

06

What researchers measure

Primary outcomes

  1. Change in Appendicular Skeletal Muscle Mass Index

    Time frame: Baseline, Week 6, and Week 8

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Aug 2027, 12 months later.

Of 17 interventional studies with no phase under Intestinal Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 59. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2026
First posted
Aug 12, 2026
StartEst.
Aug 28, 2026
Primary completionEst.
Aug 28, 2027
CompletionEst.
Oct 28, 2027
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07759271
Lead sponsor
Wang Xinying
Responsible party
Wang Xinying (Professor, Jinling Hospital, China) — Sponsor-investigator
First posted
Aug 12, 2026
Start date
Aug 28, 2026 (estimated)
Primary completion
Aug 28, 2027 (estimated)
Completion
Oct 28, 2027 (estimated)
Last update
Aug 12, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion