Efficacy and safety of KID7 Pediococcus pentosaceus on serum cholesterol; A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002510

Enrollment

Registered

2017-10-27

Start date

2016-03-03

Completion date

Unknown

Last updated

2019-03-11

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 : Subjects take Pediococcus pentosaceus KID7 or Placebo bid, each time 2g, per day directly or with water for 12weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Male and female subject aged between 20 years and 70 years 2) Subjects with Serum total cholesterol 200 ~ 239 mg/dl or LDL-cholesterol 130 ~ 189 mg/dl 3) Subjects who agree to participate in the study and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1) Subjects who taking anti-hypercholesterolemia within the 3 months prior to screening. 2) Subjects who drinks alcohol 4 times per a week 3) Subjects who get hospitalization, medications or rehabilitation treatments for cardiovascular disease, disorder of central nervous system 4) Serum creatinine = 2 times the upper limit of normal 5) Serum AST/ALT = 3 times the upper limit of normal 6) Subjects for uncontrolled hypertension, diabetes mellitus, thyroid disease (If that patient's clinical status is stable, they can participate in the clinical trial in the sight of investigator) 7) Subjects who complain gastrointestinal symptoms such as heartburn, dyspepsia 8) Subjects with Gallbladder disease or gout, porphyrias 9) Subjects with CNS disorder (depressive disorder, schizophrenia, alcoholism, drug addiction) 10) Subjects with malnutrition 11) Women who are pregnant or lactating or planning to get pregnant 12) Subjects who have a plan to participate in other clinical trial 13) Participation in any clinical trial within the 3 months prior to screening 14) Subjects which in the opinion investigator could affect preclude evaluation of response.

Design outcomes

Primary

Measure	Time frame
Total cholesterol;LDL-cholesterol;HDL-cholesterol	—

Secondary

Measure	Time frame
Triglyceride;Apoprotein A1 ;Apoprotein B;Lipoprotein A;Apolipoprotein E;AI: Atherogenic Index;Oxidized LDL level;Paraoxonase activity level;CETP activity level, LCAT activity level;Body Mass Index	—

Countries

Korea, Republic of

Contacts

Public ContactHee Chul Kang

Yonsei University Health System, Severance Hospital

kanghc@yuhs.ac+82-2-2228-2332

Outcome results