Study for evaluation of cholesterol lowering effect, dose and safety of Bifidobacterium breve IDCC 4401

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0003040

Enrollment

Registered

2018-07-30

Start date

2018-06-04

Completion date

Unknown

Last updated

2020-05-18

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 : low or high dose of Bifidobacterium breve IDCC 4401 once a daily for 12 weeks low dose: 1.0 x 10^10 cells capsule once a day high dose: 1.0 x 10^11 cells capsule once a day contro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) who agree to participate and consent 2) age of 20 or greater 3) 100mg/dl <= Low density lipoprotein cholesterol <150 mg/dl

Exclusion criteria

Exclusion criteria: 1) use of lipid modifying drug within one month 2) cardiovascular disease, uncontrolled hypertension (systolic blood pressure >=160mmHg or diastolic blood pressure >=100mmHg) , uncontrolled diabetes mellitus (fasting blood glucose >=180mg/dL)AST or ALT>= 3 x upper limit of reference value, serum creatinine >= 1.4 mg/dL, Gastrointestinal disease, autoimmune diesase, endocrine disease (hyper or hypothyroidism), malignancy 3) triglyceride >= 500 mg/dL 4) regular use of functional food altering lipid profiles within 1 month (phytosterol, omega-3, dietary fiber etc) 5) alcohol dependency 6) who participate other clinical trial within one month 7) hypersensitivity to probiotics 8) pregnancy or lactating women 9) person who is inappropriate to participate study determined by investigator

Design outcomes

Primary

Measure	Time frame
changes of LDL cholesterol;adverse reaction, vital sign, ECG, blood chemistry, urinalysis	—

Secondary

Measure	Time frame
lipid profiles (triglyceride, total cholesterol, HDL-cholesterol, VLDL-cholesterol, non HDL-cholesterol, Apo AI, apo AII, apo B, apo E - total cholesterol/HDL-cholesterol, LDL-cholesterol/HDL-cholesterol, triglyceride/HDL-cholesterol, non HDL-cholesterol/HDL-cholesterol, LDL-cholesterol/Apo B, Apo B/Apo AI - Lp(a), oxidized LDL;highly sensitive C-reactive protein;bowel habit changes and Bristol stool scale	—

Measure

Time frame

lipid profiles (triglyceride, total cholesterol, HDL-cholesterol, VLDL-cholesterol, non HDL-cholesterol, Apo AI, apo AII, apo B, apo E - total cholesterol/HDL-cholesterol, LDL-cholesterol/HDL-cholesterol, triglyceride/HDL-cholesterol, non HDL-cholesterol/HDL-cholesterol, LDL-cholesterol/Apo B, Apo B/Apo AI - Lp(a), oxidized LDL;highly sensitive C-reactive protein;bowel habit changes and Bristol stool scale

—

Countries

Korea, Republic of

Contacts

Public ContactHyun-Jae Kang

Seoul National University Hospital

Outcome results