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

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0002934
• Lead Sponsor: Inha University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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/d

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total cholesterol

Secondary Outcome Measures

Name	Time	Method
Blood lipid profiles;Bowel habit;Clinical laboratory test (blood, urine)