Effects of dietary fiber on gut microbiota in coronary artery disease

JRCT ID: jRCTs071230122

Registered date:07/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: chronic coronary syndrome
• Date of first enrollment: 07/03/2024
• Target sample size: 50
• Study type: Interventional
• Intervention(s): PHGG (SunFiberR) at a dose of 6g per serving, three times a day after each meal, for a duration of 28 days

Outcome(s)

• Primary Outcome: Pre and post serum TMAO(Tri-methylamine N-oxide)levels

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 90age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Tsujita Kenichi
• Secondary Sponsor: Matsuzawa Yasushi
• Source(s) of Monetary Support: TAIYO KAGAKU