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Clinical Trial for the Evaluation of the Efficacy and Safety of WHS on Reducing Body Weight and Body Fat of Overweight or Obesity subjects

A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of WHS on Reducing Body Weight and Body Fat of Overweight or Obesity subjects

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005594
Enrollment
120
Registered
2020-11-12
Start date
2020-10-26
Completion date
Unknown
Last updated
2020-12-02

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 test group or Placebo. Subjects will take 1 tablet once a day for 12 weeks

Sponsors

H Plus Yangji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Subjects between 19 ~65 years of age 2) BMI of visit 1,2 is placed on 25 kg/m2 ~ 32 kg/m2 3) Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial.

Exclusion criteria

Exclusion criteria: 1) Subject with severe cerebrovascular disease (infarct, hemorrage), cardiac disease (angina, myocardiac infarct, heart failure, arrhythmias that require treatment). (If that patient's clinical status is stable, they can participate in the clinical trial according to investigator) 2) Subject who was taking drugs that affect body weight within the past month{drugs for obesity(including appetite suppressants, liposuction inhibitor, GLP-1 receptor agonists), psychiatric drugs such as depression, beta blockers, diuretics, birth control pills, steroids)}, health functional foods / supplements related to obesity improvement 3) Patients with uncontrolled hypertension (over 160 / 100mmHg, after 10 minutes of stabilization) 4) Subject who fasting blood glucose = 126 mg/dL or diabetic patients use of hypoglycemic agent or insulin 5) Subject who TSH = 0.1 µU/ml or = 10 µU/ml 6) Subject who more than 2 times the upper limit of normal Creatinine of clinical trial institution 7) Subject who more than 3 times the upper limit of normal AST(GOT) or ALT(GPT) of clinical trial institution 8) Subject with severe gastrointestinal disturbances who are suffering from ingestion of test food 9) Subject with Alcohol disorders, disorder of central nervous system 10) Subject who are determined to be unable to exercise due to musculoskeletal disorders 11) Subject who have had a weight change of 10% or more within the last 3 months 12) Subject who have participated in a commercial obesity program in the past 3 months

Design outcomes

Primary

MeasureTime frame
Fat mass by DEXA(Dual-energy X-ray absorptiometry)

Secondary

MeasureTime frame
weight;Waist Circumference, Hip Circumferenc, Waist to Hip Ratio;Body Mass Index(BMI);Percent Body Fat, Lean Mass by DEXA(Dual-energy X-ray absorptiometry);Visceral Fat Area, Subcutaneous Fat Area, Taoal Fat Area,Visceral fat / Subcutanesou Fat Ratio by CT;Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride;hs-CRP;Adiponectin, Leptin

Countries

Korea, Republic of

Contacts

Public ContactSeung Hyun Kang

H Plus Yangji Hospital

Outcome results

None listed

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