None listed
Conditions
Interventions
Dietary Supplement : Subjects will take one capsule of the IP(containing B. longum NBM7-1) once a day at suitable times with sufficient water for 8 weeks, starting from the evening of randomization. S
Sponsors
Chong Kun Dang Bio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals who have voluntarily given written informed consent after receiving adequate information about this trial. 2. Adults, both male and female, aged between 19 and 65 years as of the date of written consent. 3. Individuals with a Body Mass Index (BMI) of 25 kg/m² to less than 30 kg/m². 4. Individuals with a fasting blood glucose level of 100-125 mg/dL or a 2-hour postprandial blood glucose level of 140-199 mg/dL.
Exclusion criteria
Exclusion criteria: - Pregnant or lactating women. - Women of childbearing potential and men who are unwilling or unable to use appropriate contraception methods during the trial. - Women who have given birth within the last 6 months prior to screening. - Individuals with the following conditions or medical history: Uncontrolled hypertension, diabetes, neurological or endocrine disorders affecting body weight, Severe mental illness, alcohol abuse, malignant tumors, Severe cerebrovascular, Individuals with severe concomitant diseases/disabilities deemed unsuitable for participation by the investigator etc. - Individuals administered the following drugs and food: Blood glucose-lowering medication, anti-obesity drugs or significant weight-changing medication etc. - Hypersensitivity to any component of the study food or other allergies deemed unsuitable for participation by the investigator. - Weight change of more than 5% within the past month. - Participation in another study involving clinical trial drugs, foods, or medical devices within the past 3 months. - Any other reasons deemed by the investigator as inappropriate for conducting the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight at 4 and 8 weeks post-consumption of the study food, compared to baseline.;Subjective appetite assessment score after 4 weeks and 8 weeks post-consumption of the study food.;Change in body fat mass, body fat percentage, and lean body mass measured by DEXA at 4 weeks and 8 weeks post-consumption of the study food, compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in fasting total GLP-1 at 4 and 8 weeks post-consumption of the study food, compared to baseline. | — |
Countries
Korea, Republic of
Contacts
Public ContactJong Cheon Joo
Wonkwang University Oriental Medical Hospital, Jeonju
Outcome results
None listed