Intestinal FailureNCT07759271
Effects of Whey Protein and Resistance Training on Muscle Mass in Patients With Intestinal Failure
A study testing Whey Protein Supplementation Group and Resistance Training Group in people with Intestinal Failure and Low Muscle Mass, run by Wang Xinying.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intestinal Failure, Low Muscle Mass
- What is being tested?
- Whey Protein Supplementation Group and Resistance Training Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2026to 28 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Known allergy to whey protein.
- Severe renal dysfunction.
About this study
Official title: Effect of Whey Protein Supplementation Combined With Resistance Training on Muscle Mass in Patients With Intestinal Failure: A Randomized Controlled Trial
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
- Being tested
- Whey Protein Supplementation Group, Resistance Training Group
- Keywords
- Chronic Intestinal Failure, Low Muscle Mass, Resistance Training, Appendicular Skeletal Muscle Mass Index, Physical Function
- Medical subject headings
- Intestinal Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein Supplementation GroupOther
Participants will receive standardized basic nutritional support and 20 g of whey protein orally once daily for 6 weeks.
Resistance Training GroupOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Whey Protein Supplementation Group; Other: Resistance Training Group |
| Whey Protein Supplementation Group | Experimental | Not described Receives: Other: Whey Protein Supplementation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Appendicular Skeletal Muscle Mass Index
Measured: Baseline, Week 6, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start28 Aug 2026 (estimated)
- Primary completion28 Aug 2027 (estimated)
- Study completion28 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Xinying
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang Xinying, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759271
- Sponsor's protocol ID
- 2026DZKY-134-01
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whey Protein Supplementation Combined With Resistance Training on Muscle Mass in Patients With Intestinal Failure: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07759271
- Acronym / sponsor ID
- 2026DZKY-134-01
- Conditions
- Intestinal Failure, Low Muscle Mass
- Keywords
- Chronic Intestinal Failure, Low Muscle Mass, Resistance Training, Appendicular Skeletal Muscle Mass Index, Physical Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Wang XinyingUniversity, hospital or other
- Study start
- 28 Aug 2026 (estimated)
- Primary completion
- 28 Aug 2027 (estimated)
- Study completion
- 28 Oct 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Resistance Training GroupParticipants 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. |
| Combined Intervention Group | Experimental | Other: Whey Protein Supplementation Group, Other: Resistance Training GroupParticipants 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. |
| Whey Protein Supplementation Group | Experimental | Other: Whey Protein Supplementation Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Known allergy to whey protein.
- Severe renal dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey Protein Supplementation GroupParticipants will receive standardized basic nutritional support and 20 g of whey protein orally once daily for 6 weeks. | Other | Combined Intervention Group, Whey Protein Supplementation Group |
| Resistance Training GroupParticipants 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. | Other | Combined Intervention Group, Resistance Training Group |
Primary outcome
Change in Appendicular Skeletal Muscle Mass Index
Time frame: Baseline, Week 6, and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein Supplementation Group and Resistance Training Group in people with Intestinal Failure and Low Muscle Mass, run by Wang Xinying.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Appendicular Skeletal Muscle Mass Index (time frame: Baseline, Week 6, and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.