A human trial to Fermented hot pepper(Gochujang powder)on intestinal microflora and menopausal women's health

A 8 weeks, randomized, double-blind human trial to evaluate the efficacy and safety of Fermented hot pepper(Gochujang powder)on intestinal microflora and menopausal women's health

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011085

Enrollment

Registered

2025-10-30

Start date

2025-06-02

Completion date

Unknown

Last updated

2026-02-02

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 hot pepper TCG25-26 (High-Content Functional Microorganism Gochujang Powder) Group: Orally administered 3 sachets, twice a day(morning/evening after meals) for 8 weeks

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Adult women aged 45 to 70, who are postmenopausal, with a Kupperman Index score of 15 or higher and a Body Mass Index (BMI) of 23 kg/m2 or higher.

Exclusion criteria

Exclusion criteria: 1. Individuals who are currently receiving Hormone Replacement Therapy (HRT) or have a history of HRT within the last 6 months. 2. Individuals with current or past history of endometrial hyperplasia, uterine cancer, endometrial cancer, breast cancer or suspected breast disease, or sex hormone-related cancers. 3. Individuals who are undergoing or have a history of chemotherapy or radiotherapy that may affect ovarian function. 4. Individuals with a history of bilateral oophorectomy. 5. Individuals who have taken pharmaceuticals or health functional foods related to gut microbiota and menopausal women's health within 1 month prior to the screening visit (Refer to prohibited concomitant medications). 6. Individuals with a history of significant hypersensitivity reaction to chili pepper or gochujang ingredients. 7. Individuals who have received antipsychotic medication treatment within 3 months prior to the screening visit. 8. Individuals with known or suspected alcoholism or substance abuse. 9. Individuals who have participated in other human application trials within 3 months prior to the screening visit. 10. Individuals who are judged to be unsuitable for study participation by the Principal Investigator due to other reasons, including results from diagnostic laboratory tests.

Design outcomes

Primary

Measure	Time frame
Change in gut microbiota;Modified Kupperman’s index	—

Secondary

Measure	Time frame
Body Composition Analysis;Body Measurements;Lipid Metabolism Markers;Inflammatory Markers;Glycemic Markers;Short-Chain Fatty Acids;EuroQol-5 Dimensions	—

Countries

Korea, Republic of

Contacts

Public ContactA Reum Han

Wonkwang University Hospital

qibosarang@naver.com+82-63-859-2543

Outcome results