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A 12week, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of BST898 on reducing body weight and body fat of overweight subjects

A 12week, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of BST898 on reducing body weight and body fat of overweight subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0001452
Enrollment
100
Registered
2015-04-16
Start date
2015-05-12
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 will be randomized to receive BST898 510mg or placebo. Subjects will orally self-adminster BST898 or placebo bid, 2Tab per day for 12weeks.

Sponsors

Biostream Technologies
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial. 2) Male and female subjects between 20-60years of age inclusive 3)BMI of 25.0-29.9kg/m2

Exclusion criteria

Exclusion criteria: 1)The Patients with severe cerebrovascular disease, cardiac disease (If that patient's clinical status is stable, they can participate in the clinical trial according to investgator) 2)Subjects with systolicBP = 160 mmHg or diastolicBP = 100 mmHg and also taking a beta blocker or a hydragogue. 3)Subjects with diabetes(use of hypoglycemic agent or insulin)or fasting blood glucose = 126 mg/dL or random blood glucose = 200 mg/dL. 4)TSH(Thyroid Stimulating Hormone) value =0.1uU/ml or =10 uU/ml 5)Serum creatinine = 2 times the upper limit of normal. 6)Serum AST(Aspartate aminotransferase)/ALT(Alanine aminotransferase) = 3 times the upper limit of normal. 7)Subjects who complain gastrointestinal symptoms such as heartburn, dyspepsia 8)The patient who take the medicine that can affect the state of weight change (uptake inhibitors, appetite suppressant, Antipsychotics hydragogue, contraceptives, steroid, and female sex hormon) within recent 1 months. 9)Participation in commercial diet program within the 3 months prior to screening. 10)Participation in any clinical trail within the 1 month prior to screening or have a plan to participate in other clinical trial. 11)Subjects who get hospitalization, medications or rehabilitation treatments for Alcohol disorders, cardiovascular disease, disorder of central nervous system. 12)Subjects with the musculoskeletal disorders or restricted physical activity. 13)Woman who are pregnant of lactating or planning to pregnant 14)Subjects which in the opinion investigator could affect preclude evluation of response

Design outcomes

Secondary

MeasureTime frame
Body weight , Body mass index(BMI) ;Waist circumference, Hip circumference, waist-hip ratio(WHR) ;Fat mass, Fat Free Mass(by Dual Energy X-Ray Absorptiometry, DEXA) ;Mesenteric fat area, Subcutaneous fat area, Total abdominal fat area, Mesenteric fat area/Subcutaneous fat area(by CT) ;Blood Lipid ;Adiponectin, Leptin, hs-CRP( high-sensitivity C-reactive protein)

Primary

MeasureTime frame
Chainge in fat percentage(by Dual Energy X-Ray Absorptiometry, DEXA)

Countries

Korea, Republic of

Contacts

Public ContactJae Kang

Inje University Seoul Paik Hospital

gpdud7817@naver.com+82-2-2270-0960

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026