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Exploring the mechanism of action of dietary fibre in reducing trimethylamine in patients with chronic kidney disease based on the involvement of gut flora in the choline-oxidized trimethylamine metabolic pathway: A randomised controlled trial

Exploring the mechanism of action of dietary fibre in reducing trimethylamine in patients with chronic kidney disease based on the involvement of gut flora in the choline-oxidized trimethylamine metabolic pathway

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076872
Enrollment
Unknown
Registered
2023-10-23
Start date
2019-11-01
Completion date
Unknown
Last updated
2023-10-30

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

Conditions

Chronic kidney disease

Interventions

Dietary fibre intervention group:Patients were randomly assigned to the intervention group and supplemented with 15 g of soluble fibre per day for 30 days.
Placebo group :Patients were randomly assigned to the placebo group and supplemented with 15 grams of starch per day for 30 days.

Sponsors

Shanghai Fifth People’s Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with confirmed CKD who meet the diagnostic and staging criteria for CKD; 2. Age 18~70 years old; 3. Han nationality; 4. Glomerular filtration rate =89mL/min/1.73 m2; 5. No diabetes mellitus before screening; 6. No use of antibiotics in the past 1 month; 7. Those who did not drink yoghurt and probiotics during the voluntary trial; 8. Informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Comorbidities of severe cardiovascular and metabolic diseases; 2. Pregnant or breastfeeding women; 3. Participated in other clinical trials in the past 3 months or have taken antibiotics within 1 month; 4. Those who drank yoghurt or probiotics within 2 days before the start of the trial; 5. Unwilling participants.

Design outcomes

Primary

MeasureTime frame
Trimethylamine N-oxide;Gut microbiota;

Secondary

MeasureTime frame
Blood biochemical indicators;Chronic inflammatory indicators;

Countries

China

Contacts

Public ContactShao Chunhai

Shanghai Fifth People’s Hospital, Fudan University

2257139538@qq.com+86 137 9540 4367

Outcome results

None listed

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