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Effects of flavonoid diet intervention on intestinal flora and stress state in cancer patients

Effects of flavonoid diet intervention on intestinal flora and stress state in cancer patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048727
Enrollment
Unknown
Registered
2021-07-13
Start date
2021-07-05
Completion date
Unknown
Last updated
2022-03-21

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

Conditions

Advanced malignant solid tumor

Interventions

Intervention group:High flavonoid content fruit and vegetable diet guidance
Control group:No

Sponsors

Xiang'an Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed as advanced malignant solid tumor with definite pathological and CT imaging evidence; 2.F&V diets are below the average of 4.4 servings per day; 3.Male or female, age 18 ~80 years old; 4.Karnofsky score >=60; 5.Expected survival >=3 months; 6.Subjects must give informed consent to the study before the study and voluntarily sign a written informed consent, which shows good compliance; 7.The major organs are functioning normally.

Exclusion criteria

Exclusion criteria: 1. Have taken antibiotics within 5 weeks before enrollment; 2. Use of probiotic and/or prebiotic supplements and/or complementary foods before enrollment and throughout the study (=3 times/week); 3. Patients who received other study drugs within 30 days before randomization; 4. Receive psychotropic drug treatment (antidepressants, anti-anxiety drugs, anti-manic drugs, etc.) within 3 months before enrollment; 5. Patients who have received systemic corticosteroids (prednisone>10mg/day or equivalent doses of similar drugs) or other immunosuppressive drugs within 14 days before enrollment, except for the following patients: using topical, eye, joint Intracavitary, intranasal, and inhaled corticosteroid therapy; short-term corticosteroid prophylaxis (eg, docetaxel prophylaxis, contrast hypersensitivity); 6. Cognitive and communication barriers; 7. Female patients are pregnant or breastfeeding; 8. The investigator believes that there are any other conditions that may adversely affect the participant's compliance or indicator measurement in completing the study, or any other situation that may pose a significant risk to the participant.

Design outcomes

Primary

MeasureTime frame
Flavonoid markers;Salivary cortisol;Blood cortisol;Gut microbiota;Mental Health Assessment Questionnaire;Fecal short chain fatty acids;Changes in defecation habits and traits;

Secondary

MeasureTime frame
Immune cells and cytokines;

Countries

China

Contacts

Public ContactKang Xinmei

Department of Oncology, Xiang'an Hospital of Xiamen University, Xiamen University

kxm791107@163.com+86 13720879248

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026