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A human trial of Fermented soybean(Doenjang powder) on intestinal microflora and improvement of blood cholesterol

A 4 weeks, randomized, double-blind human trial to evaluate the efficacy and safety of Fermented soybean(Doenjang powder) on intestinal microflora and improvement of blood cholesterol

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008862
Enrollment
45
Registered
2023-10-11
Start date
2023-05-16
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

None listed

Interventions

Dietary Supplement : • Fermented soybean TCD23-5(high content of effective microorganisms, Doenjang powder): twice a day, 1 pack once, after breakfast/dinner(6 g/day, 6 g/day for fermented soybean) •

Sponsors

Jeonbuk National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adult men and women aged 19 years or older and 75 years old or younger at the screening test. 2) Subjects with an LDL-cholesterol of 130 mg/dL or more or a total cholesterol of 200 mg/dL or more in a fasting blood test at the screening test.

Exclusion criteria

Exclusion criteria: 1) Those with clinically significant acute or chronic cardiocerebrovascular, endocrine, immune, respiratory, hepatobiliary, renal and urinary, neuropsychiatric, musculoskeletal, inflammatory and hematologic neoplastic, gastrointestinal, systemic and infectious diseases requiring treatment. 2) Those who have taken medicines and health functional foods related to improving intestinal flora and cholesterol within 1 month before screening 3) Those who are taking diabetes medications at the screening test. 4) Patients with uncontrolled hypertension at the screening test. 5) Those who have received antipsychotic drug treatment within 3 months prior to screening test. 6) Those with or suspected of alcoholism or drug abuse 7) pregnant or lactating women 8) Women of childbearing potential who do not accept the practice of adequate contraception 9) Those who participated in other human application tests within 3 months prior to screening test.

Design outcomes

Primary

MeasureTime frame
change of intestinal microbiome;lipid metabolism index

Secondary

MeasureTime frame
lipid metabolism index;Atherogenic index;inflammatory markers;Short chain fatty acids

Countries

Korea, Republic of

Contacts

Public ContactHui-yeon Jang

Jeonbuk National University Hospital

janghy@jbctc.org+82-63-259-3046

Outcome results

None listed

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