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Clinical Trials/KCT0008095
KCT0008095
Completed
未知

A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of PB1 on Reducing Body Fat

Kangbuk Samsung Medical Center0 sites30 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Kangbuk Samsung Medical Center
Enrollment
30
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
October 28, 2022
Last Updated
3 years ago
Study Type
Interventional Study
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\) Aged 19 or older and younger than 65
  • 2\) Body mass index (BMI) is more than 25 kg/m²and 35 kg/m² or less
  • 3\) A person who agreed to participate in this Clinical Study and filled out the written informed consent form.

Exclusion Criteria

  • 1\) Those currently undergoing treatment for urinary system, nervous system, mental, infectious diseases, malignant tumors, etc.
  • 2\) Drugs that affect weight within 1 month (30 days) of visit 1, {anti\-obesity drugs (appetite suppressants, fat absorption inhibitors, GLP\-1 receptor agonists, etc.), psychiatric drugs such as depression and schizophrenia, beta\-blockers, diuretics, birth control pills, steroids}, health functional foods/supplements for weight control purposes, herbal medicines, and weight control formulas.
  • 3\) Taken hyperlipidemia drugs within 1 month (30 days) from Visit 1 or who have taken omega\-3 within 2 weeks from Visit 1\.
  • 4\) Taken antibiotics within 2 weeks of visit 1\.
  • 5\) Consumed probiotics, prebiotics, synbiotics and fermented products continuously (more than 4 times a week) within 2 weeks from visit 1\.
  • 6\) Patients with uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg).
  • 7\) Diabetic patients with fasting blood sugar of 126 mg/dL or higher or taking antidiabetic drugs (oral hypoglycemic drugs, insulin, etc.)
  • 8\) A person with TSH is less than 0\.1 µIU/mL or more than 10 µIU/mL
  • 9\) A person whose creatinine is more than twice the upper limit of the study institution.
  • 10\) A person whose AST (GOT) or ALT (GPT) is more than 3 times the upper limit of the study institution.

Outcomes

Primary Outcomes

Not specified

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