Human trial to evaluate the efficacy and safety of Lactobacillus acidophilus NS1 on cholesterol improvement

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002934

Enrollment

100

Registered

2018-06-19

Start date

2018-02-26

Completion date

Unknown

Last updated

2019-05-20

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 consume Lactobacillus acidophilus NS1 or placebo for 12 weeks (Lactobacillus acidophilus NS1 5 x 109 CFU/stick, 1 stick a day)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subject who voluntarily agree to participate and signs informed consent form 2) Age=20 years 3) 200 mg/dL =Total cholesterol<240 mg/dL

Exclusion criteria

Exclusion criteria: 1) Subjects who had consistently consumed the drug related to lipid metabolism (ex. statin, ezetimibe, diuretics, fibrate, beta blocker, acetylsalicylic acid, bile acid-binding resins, etc.) or oriental medicine within 1 month before the first visit, except for the subject who have taken thiazide among the diuretics or beta blockers without change of dose during last one year and expected not to change the dosage during the study period. 2) Following diseases: - Familial hypercholesterolemia, past history of myocardial infarction or stroke - Uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg) - Uncontrolled diabetes (fasting glucose level = 180 mg/dL) - Liver dysfunction (AST, ALT = 3 X upper limit of normal range) - Renal dysfunction (serum creatinine = 1.4 mg/dL) - Gastrointestinal disease, autoimmune disease, endocrine disease (hyperthyroidism, hypothyroidism, etc), malignant tumor 3) Triglyceride = 300 mg/dL 4) Women receiving hormone therapy 5) Subjects who consumed the functional food related to lipid metabolism within 1 month before the first visit consistently (example: plant sterol, w-3 fatty acid, psyllium husk, aloe, chitosan, onion extract, dietary fiber, etc) 6) BMI (Body Mass Index) < 18.5 kg/m2 or = 35.0 kg/m2 7) Subjects who are controlling body weight or subjects who have changed of body weight more than 10% within 6 months before the first visit 8) Heavy smoker (= 20 cigarettes / day) 9) Subjects with alcoholism or subjects who consume of alcohol more than 350g per week (example: soju about 6 bottles/week or 6 glasses/day) 10) Excessive exercise (= 10 hours / week) 11) Participation in other clinical study within 1 month before the first visit 12) Subjects who are hypersensitive to probiotics 13) Pregnant or lactating women 14) Inappropriate subject decided by the investigator

Design outcomes

Primary

Measure	Time frame
Total cholesterol	—

Secondary

Measure	Time frame
Blood lipid profiles;Bowel habit;Clinical laboratory test (blood, urine)	—

Countries

Korea, Republic of

Contacts

Public ContactHwan-Cheol Kim

Inha University Hospital

cheol17@hanmail.net+82-32-890-3216

Outcome results