Clinical Trial to Test Anti-Obesity effect of JINIS JBD301 on Humans

Phase II Randomized, Double-Blind Study of JINIS JBD301 in Obese Adults

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0000452

Enrollment

110

Registered

2012-06-01

Start date

2011-11-07

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 : Lactobacillus JBD301 was provided in capsules. Subjects consumed a JBD301 capsule or a control capsule every day for 12 weeks. Two types of capsules were prepared: a capsule cont

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Written informed consent 2) Men and women between 20-65 years of age 3) Body mass index between 25 ~ 35kg/m2

Exclusion criteria

Exclusion criteria: 1) Subjects who have received antibiotics within 12 week prior to the first visit 2) Subject with current use of medications for body weight reduction (lipase inhibitor, anti-depressants, appetite suppressant), diuretics, contraceptives, steroids, and hormones 3) Subjects who have been involved in commercial diet programs or under diet formula within 12 weeks prior to the first visit 4) Subjects with uncontrolled hypertension or diabetes 5) Subjects with current medical conditions, including cardiac, renal, hepatic, neurovascular, thyroid and parathyroid disorders/diseases 6) Subjects with medical conditions, including depression, schizophrenia, psychosis, alcohol abuse and drug abuse 7) Subjects diagnosed with cancer within 5 years 8) Subjects with hyper-allergic conditions to components in the testing food 9) Subjects who is planning to reduce body weight by food and exercise during the clinical trial period 10) Subject with current pregnancy or breast feeding 11) Subject is otherwise unsuitable for the study, in the opinion of the investigator

Design outcomes

Primary

Measure	Time frame
Total abdomenal fat (CT) value;Body Weight, BMI;Total abdomenal fat (CT) variation;Blood lipid profile: TG, TC, LDL-C, HDL-C, free fatty acid ;Glucose: fasting blood glucose, blood insulin, HbA1c	—

Secondary

Measure	Time frame
Abnormal reaction, Vital signs(blood pressure, Pulse), Laboratory tests(complete blood and urine tests)	—

Countries

Korea, Republic of

Contacts

Public ContactJaesun Lee

Samsung Medical Center

Outcome results