Diet HabitsPhase 1NCT07477522
Effects of High-Fiber Diet on Gut Microbiota, Metabolism, and Immune Microenvironment in Solid Tumor Patients: A Clinical Study
A Phase 1 study testing High-fibre diet in people with Diet Habits and High-fibre Diet, run by West China Hospital at 2 sites in China.
Trial summary
Cancer remains a major global public-health challenge and a central focus of medical research. According to the International Agency for Research on Cancer (IARC, 2020), 19.29 million new malignant tumors and 9.96 million cancer deaths occurred worldwide, >90% being solid cancers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diet Habits, High-fibre Diet, Solid Tumor Cancer
- What is being tested?
- High-fibre diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2025to 30 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Sign a written informed consent form before any study-related procedures are carried out.
- (2) Males or females, aged 18-75 years old.
- (3) Diagnosed with solid tumors by pathological tissue biopsy.
- (4) According to the RECIST v1.1 (Response Evaluation Criteria in Solid Tumors Version 1.1) criteria, there is at least 1 measurable lesion (lesions previously treated with local therapies such as radiotherapy cannot be regarded as measurable lesions).
- (5) ECOG (Eastern Cooperative Oncology Group Performance Status) score of 0-1.
- (6) NRS-2002 (Nutritional Risk Screening 2002) score < 3.
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- (7) BMI (Body Mass Index) ≥ 18.5 (can be adjusted appropriately according to the actual situation).
- (8) Patients who can eat orally or through a feeding tube and can tolerate enteral nutrition.
- (9) Sufficient organ function, and the subjects need to meet the following laboratory indicators: In the absence of granulocyte-colony-stimulating factor use in the past 14 days, the absolute neutrophil count ≥ 1.5×10⁹/L.
- Platelets ≥ 75×10⁹/L. In the absence of blood transfusion or erythropoietin use in the past 7 days, hemoglobin ≥ 8 g/dL.
- Serum albumin ≥ 3.0 g/dL. Total bilirubin ≤ 1.5× the upper limit of normal (ULN). Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5×ULN. In case of liver metastasis, ALT and/or AST ≤ 5×ULN, and total bilirubin ≤ 3×ULN. In case of liver or bone metastasis, Alkaline Phosphatase (AKP) ≤ 5×ULN.
- Creatinine clearance rate ≥ 50 mL/min (calculated according to the Cockcroft - Gault formula) or serum creatinine ≤ 1.5×ULN.
- International Normalized Ratio (INR) ≤ 1.5×ULN, Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN.
- Urine protein < 2+ (if urine protein ≥ 2+, a 24-hour urine protein quantification can be performed, and subjects with a 24-hour urine protein quantification < 2.0 g can be enrolled).
- (10) Women of childbearing potential must agree to abstain from heterosexual intercourse or use a reliable and effective contraceptive method from the time of signing the informed consent form until at least 6 months after the last administration of concomitant anticancer treatment. A serum human chorionic gonadotropin (HCG) test must be negative within 3 days before initiation of the study intervention, and the participant must not be breastfeeding. Women are considered to be of childbearing potential unless they are postmenopausal, defined as amenorrhea for at least 12 consecutive months without an alternative medical cause, or have undergone surgical sterilization, such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy.
- (11) If there is a risk of pregnancy, all subjects (regardless of sex) must use a contraceptive method with an annual failure rate of less than 1% throughout the treatment period and until 120 days after the last administration of concomitant anticancer treatment, or 180 days after the last administration of chemotherapy.
- (12) Baseline dietary fiber intake <15 g/day, estimated using the National Cancer Institute Dietary Screener Questionnaire (NCI-DSQ) based on dietary intake during the preceding 30 days.
Who cannot join
- (1) Patients with cognitive impairment or mental illness who are unable to understand the study content.
- (2) Patients with central nervous system or meningeal metastases.
- (3) Patients with clinically symptomatic moderate or severe ascites (that is, those who require therapeutic paracentesis within 2 weeks before the start of study treatment; patients with only a small amount of ascites shown on imaging and no clinical symptoms can be enrolled).
- (4) Patients with uncontrolled or moderate to severe pleural effusion and pericardial effusion.
- (5) Patients with severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic and mechanical intestinal obstruction; tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula, or abdominal abscess; patients with extra - gastrointestinal bleeding with a CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or above within 6 months before the start of study treatment or grade 2 or above within 3 months (such as abnormal vaginal bleeding, hematemesis).
- (6) Patients known to be allergic to any component of the dietary fiber supplement.
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- (7) Patients with poorly controlled diabetes.
- (8) Patients with poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg under routine antihypertensive treatment), with a history of hypertensive crisis or hypertensive encephalopathy.
- (9) Patients with severe cardiovascular and cerebrovascular diseases, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, and major vascular diseases within 6 months before enrollment (including but not limited to aortic aneurysms requiring surgical repair or recent arterial thrombosis); patients with poorly controlled clinical symptoms or heart diseases, such as unstable angina pectoris, NYHA (New York Heart Association) heart failure grade II or above, left ventricular ejection fraction < 50% on color Doppler echocardiography, or severe arrhythmias that cannot be controlled by drug treatment.
- (10) Pregnant or lactating women.
- (11) Other situations considered by the investigator as inappropriate for enrollment.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Xinjin District Hospital of Traditional Chinese Medicine
Chengdu, Sichuan, 611430
West China Hospital
Chengdu, Sichuan
About this study
Cancer remains a major global public-health challenge and a central focus of medical research. According to the International Agency for Research on Cancer (IARC, 2020), 19.29 million new malignant tumors and 9.96 million cancer deaths occurred worldwide, >90% being solid cancers. Lung cancer alone accounted for 2.2 million new cases and 1.8 million deaths; >75% of patients were already at an advanced stage at diagnosis. Current options for late-stage solid tumors are limited: surgery is often impossible because of metastasis; cytotoxic chemotherapy produces dose-limiting toxicities (grade III-IV myelosuppression 15-40%, mucositis 50-80%); radiotherapy risks pneumonitis (5-15%) or enteritis (5-20%) when tumors abut vital organs; targeted agents succumb to acquired resistance after a median 9-13 months; and immune-checkpoint inhibitors achieve <40% objective response with 7-15% grade 3-4 immune-related adverse events. Dietary intervention is therefore emerging as a promising adjunct. Dietary fibre protects against cardiovascular and metabolic diseases, yet intake is universally low. WHO and the Chinese Nutrition Society recommend 25-30 g total fibre per day (approximately 15-21 g insoluble), whereas Chinese adults consume only approximately 11 g insoluble fibre. High-fibre diets reshape gut microbiota, augment short-chain fatty acid (SCFA) production, strengthen intestinal barrier function, activate CD8⁺ T cells and dampen regulatory T cells, thereby enhancing anti-tumour immunity. A melanoma cohort showed improved progression-free survival under immunotherapy when fibre intake was high. Similar microbiota-immune axes may operate in colorectal and other solid cancers, but clinical data are scarce. This study examines whether a 6-week dietary-fibre intervention, initiated at 10 g/day during the first week and increased as tolerated to a target supplemental dose of 16-20 g/day thereafter, is associated with changes in gut-microbiota composition, faecal short-chain fatty acid profiles, and peripheral-blood immune-cell subsets in patients with solid tumours. The findings may clarify whether fibre-driven microbiota-immune crosstalk can be harnessed as a personalised nutritional strategy in patients with cancer.
- Conditions
- Diet Habits, High-fibre Diet, Solid Tumor Cancer
- Being tested
- High-fibre diet
- Keywords
- high-fibre diet, Solid Tumor Cancer
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fibre dietDietary supplement
Dietary fibre, recommended at 25-30 g/day (15-21 g/day insoluble fibre), is chronically under-consumed (approximately 11 g/day in China). High-fibre diets increase short-chain fatty acid (SCFA) production, enhance gut-barrier integrity, and boost antitumour immunity, and higher dietary fibre intake has been associated with better immunotherapy outcomes in patients with melanoma. Clinical evidence in patients with solid tumours remains limited. Participants initiated supplemental dietary fibre at 10 g/day during the first week and increased the dose as tolerated to a target supplemental dose of 16-20 g/day thereafter, for a total intervention duration of 6 weeks, while continuing their usual diet and prescribed anticancer treatment. The study evaluates whether this dietary intervention is associated with changes in gut microbiota composition, faecal short-chain fatty acid concentrations, and peripheral blood immune-cell subsets.
| Study group | Role | What they receive |
|---|---|---|
| high-insoluble-fibre diet | Experimental | Not described Receives: Dietary Supplement: High-fibre diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, Type, Frequency, and Severity of Intervention-Emergent Adverse Events
The incidence, type, frequency, and severity of intervention-emergent adverse events, with particular attention to gastrointestinal adverse events, including constipation, abdominal distension, abdominal pain, nausea, vomiting, and diarrhea.
Measured: From the first intake of the dietary fiber supplement through the end of the 6-week intervention period
Secondary outcomes (3)
Change in fecal gut microbiota composition
Changes from baseline in fecal gut microbiota composition, including microbial diversity and the relative abundance of bacterial taxa, following the high-fiber dietary intervention.
Measured: Baseline and week 6 after initiation of the dietary intervention.
Change in fecal short-chain fatty acid concentrations
Changes from baseline in fecal short-chain fatty acid concentrations, including acetate and butyrate, following the high-fiber dietary intervention.
Measured: Baseline and week 6 after initiation of the dietary intervention.
Change in peripheral blood immune-cell subsets
Changes from baseline in the proportions and phenotypic characteristics of peripheral blood immune-cell subsets following the high-fiber dietary intervention, as assessed by flow cytometry.
Measured: Baseline, week 3, and week 6 after initiation of the dietary intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Dec 2025
- Primary completion25 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitsStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- high-fibre diet
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xinjin District Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Xuelei Ma MD, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477522
- Sponsor's protocol ID
- Approval No. 1038 (2025)
- Status last verified
- Oct 2026
- First submitted
- 12 Mar 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Fiber Diet on Gut Microbiota, Metabolism, and Immune Microenvironment in Solid Tumor Patients: A Clinical Study
- ClinicalTrials.gov ID
- NCT07477522
- Acronym / sponsor ID
- Approval No. 1038 (2025)
- Conditions
- Diet Habits, High-fibre Diet, Solid Tumor Cancer
- Keywords
- high-fibre diet, Solid Tumor Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- Xinjin District Hospital of Traditional Chinese Medicine
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 17 Mar 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.
Cancer remains a major global public-health challenge and a central focus of medical research. According to the International Agency for Research on Cancer (IARC, 2020), 19.29 million new malignant tumors and 9.96 million cancer deaths occurred worldwide, >90% being solid cancers. Lung cancer alone accounted for 2.2 million new cases and 1.8 million deaths; >75% of patients were already at an advanced stage at diagnosis. Current options for late-stage solid tumors are limited: surgery is often impossible because of metastasis; cytotoxic chemotherapy produces dose-limiting toxicities (grade III-IV myelosuppression 15-40%, mucositis 50-80%); radiotherapy risks pneumonitis (5-15%) or enteritis (5-20%) when tumors abut vital organs; targeted agents succumb to acquired resistance after a median 9-13 months; and immune-checkpoint inhibitors achieve <40% objective response with 7-15% grade 3-4 immune-related adverse events. Dietary intervention is therefore emerging as a promising adjunct. Dietary fibre protects against cardiovascular and metabolic diseases, yet intake is universally low. WHO and the Chinese Nutrition Society recommend 25-30 g total fibre per day (approximately 15-21 g insoluble), whereas Chinese adults consume only approximately 11 g insoluble fibre. High-fibre diets reshape gut microbiota, augment short-chain fatty acid (SCFA) production, strengthen intestinal barrier function, activate CD8⁺ T cells and dampen regulatory T cells, thereby enhancing anti-tumour immunity. A melanoma cohort showed improved progression-free survival under immunotherapy when fibre intake was high. Similar microbiota-immune axes may operate in colorectal and other solid cancers, but clinical data are scarce. This study examines whether a 6-week dietary-fibre intervention, initiated at 10 g/day during the first week and increased as tolerated to a target supplemental dose of 16-20 g/day thereafter, is associated with changes in gut-microbiota composition, faecal short-chain fatty acid profiles, and peripheral-blood immune-cell subsets in patients with solid tumours. The findings may clarify whether fibre-driven microbiota-immune crosstalk can be harnessed as a personalised nutritional strategy in patients with cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- high-fibre diet
| Arm | Type | Receives |
|---|---|---|
| high-insoluble-fibre diet | Experimental | Dietary Supplement: High-fibre diet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- (1) Sign a written informed consent form before any study-related procedures are carried out.
- (2) Males or females, aged 18-75 years old.
- (3) Diagnosed with solid tumors by pathological tissue biopsy.
- (4) According to the RECIST v1.1 (Response Evaluation Criteria in Solid Tumors Version 1.1) criteria, there is at least 1 measurable lesion (lesions previously treated with local therapies such as radiotherapy cannot be regarded as measurable lesions).
- (5) ECOG (Eastern Cooperative Oncology Group Performance Status) score of 0-1.
Key exclusion criteria (11 listed)
- (1) Patients with cognitive impairment or mental illness who are unable to understand the study content.
- (2) Patients with central nervous system or meningeal metastases.
- (3) Patients with clinically symptomatic moderate or severe ascites (that is, those who require therapeutic paracentesis within 2 weeks before the start of study treatment; patients with only a small amount of ascites shown on imaging and no clinical symptoms can be enrolled).
- (4) Patients with uncontrolled or moderate to severe pleural effusion and pericardial effusion.
- (5) Patients with severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic and mechanical intestinal obstruction; tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula, or abdominal abscess; patients with extra - gastrointestinal bleeding with a CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or above within 6 months before the start of study treatment or grade 2 or above within 3 months (such as abnormal vaginal bleeding, hematemesis).
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 |
|---|---|---|
| High-fibre dietDietary fibre, recommended at 25-30 g/day (15-21 g/day insoluble fibre), is chronically under-consumed (approximately 11 g/day in China). High-fibre diets increase short-chain fatty acid (SCFA) production, enhance gut-barrier integrity, and boost antitumour immunity, and higher dietary fibre intake has been associated with better immunotherapy outcomes in patients with melanoma. Clinical evidence in patients with solid tumours remains limited. Participants initiated supplemental dietary fibre at 10 g/day during the first week and increased the dose as tolerated to a target supplemental dose of 16-20 g/day thereafter, for a total intervention duration of 6 weeks, while continuing their usual diet and prescribed anticancer treatment. The study evaluates whether this dietary intervention is associated with changes in gut microbiota composition, faecal short-chain fatty acid concentrations, and peripheral blood immune-cell subsets. | Dietary supplement | high-insoluble-fibre diet |
Primary outcome
Incidence, Type, Frequency, and Severity of Intervention-Emergent Adverse Events
Time frame: From the first intake of the dietary fiber supplement through the end of the 6-week intervention period
The incidence, type, frequency, and severity of intervention-emergent adverse events, with particular attention to gastrointestinal adverse events, including constipation, abdominal distension, abdominal pain, nausea, vomiting, and diarrhea.
3 secondary outcomes
Change in fecal gut microbiota composition
Time frame: Baseline and week 6 after initiation of the dietary intervention.
Change in fecal short-chain fatty acid concentrations
Time frame: Baseline and week 6 after initiation of the dietary intervention.
Change in peripheral blood immune-cell subsets
Time frame: Baseline, week 3, and week 6 after initiation of the dietary intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing High-fibre diet in people with Diet Habits and High-fibre Diet, run by West China Hospital at 2 sites in China.
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 17 inclusion and 11 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: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence, Type, Frequency, and Severity of Intervention-Emergent Adverse Events (time frame: From the first intake of the dietary fiber supplement through the end of the 6-week intervention period). 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 4 Nov 2026.