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Effects of dietary fiber on gut microbiota in coronary artery disease

Effects of soluble dietary fiber on tri-methylamine N-oxide (TMAO), a gut microbiota-derived metabolite, in patients with chronic coronary syndrome: An open-label single arm phase II trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs071230122
Enrollment
50
Registered
2024-03-07
Start date
2024-03-07
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

chronic coronary syndrome

Interventions

PHGG (SunFiberR) at a dose of 6g per serving, three times a day after each meal, for a duration of 28 days

Sponsors

Tsujita Kenichi
Lead Sponsor
Matsuzawa Yasushi
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Age 40 to 90 years old of chronic coronary syndrome (2) Not taking dietary fiber supplements or probiotics for a month (3) Written consent for participation to this study

Exclusion criteria

Exclusion criteria: 1)under taking antibiotics 2)inflammatory bowel disease 3)those with uncontrolled diabetes mellitus (HbA1c(NGSP) > 9.0% 4)active malignant disease 5)hematological disease 6)receiving steroid therapy within a month 7)patients who are pregnant, breastfeeding (including those planning to discontinue breastfeeding), or who intend to become pregnant during the course of the clinical trial 8)patients who are enrolled or planned to participate in another clinical trials 9)others, patient judged inappropriate by the attending Physician 10)elderly patients with low medication compliance, dementia, or swallowing dysfunction

Design outcomes

Primary

MeasureTime frame
Pre and post serum TMAO(Tri-methylamine N-oxide)levels

Secondary

MeasureTime frame
16S ribosomal RNA gene analysis of gut microbiota endothelial function test (EndoPAT), T-TAS, defecation frequency, Bristol stool scale, CRP, glucose, serum lipids

Contacts

Public ContactKenichi Tsujita

Kumamoto University Hospital

tsujita@kumamoto-u.ac.jp+81-96-373-5175

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026