An 8-week, randomized, double-blinded, placebo-controlled clinical trial to evaluate the efficacy and safety of Lactobacillus plantarum HAC01 on the postprandial glucose levels.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005652

Enrollment

Registered

2020-12-02

Start date

2019-10-23

Completion date

Unknown

Last updated

2021-05-24

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 : Test group: Subjects will take one capsule of L. plantarum HAC01 orally one daily for 8 weeks. Control group: Subjects will take one capsule of placebo orally one daily for 8 week

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Aged 19 to 70 years 2) Isolated-impaired glucose tolerance (plasma glucose levels from 140 to 199 mg/dl two hours after a 75 g oral glucose consumption during an oral glucose tolerance test) 3) Voluntary agreement to participate in the clinical trials and provision of informed consent

Exclusion criteria

Exclusion criteria: 1) Fasting plasma glucose level 3 fold of normal range or serum creatinine > 2.0 mg/dl 16) Female subjects of childbearing potential who are not willing to use appropriate contraception (except for surgery for female infertility) 17) Pregnant, planning to become pregnant, or breast-feeding 18) Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study

Design outcomes

Primary

Measure	Time frame
2-hour postprandial plasma glucose;Incremental area under the curve	—

Secondary

Measure	Time frame
Fasting plasma glucose;Postprandial plasma glucose (30, 60, and 90 min);Fasting insulin;HOMA-IR, QUICKI;Lipid profile (total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol);Adiponectin;Leptine;Short chain fatty acid;Gut microbiome	—

Countries

Korea, Republic of

Contacts

Public ContactMi-Ra Oh

Jeonbuk National University Hospital

mroh@jbctc.org+82-63-250-3047

Outcome results