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Evaluation of the Efficacy and Safety of Kaempferia parviflora extract on Body Fat

A 12-week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Kaempferia parviflora extract on Body Fat

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009398
Enrollment
100
Registered
2024-05-03
Start date
2024-02-20
Completion date
Unknown
Last updated
2024-05-27

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 : Take test food (150 mg/day as Kaempferia parviflora extract) or control food (300 mg/cap as dextrin) once a day for 12 weeks with warm water

Sponsors

Dong-A University Hospital
Lead Sponsor
Korea University Ansan Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) More than 20 years old 2) The body mass index (BMI) is 25 kg/m2 or more than 25 kg/m 2 or less than 30 kg/m 2 3) Before the human application experience of this human application test before the human application test begins, and in writing agreements

Exclusion criteria

Exclusion criteria: 1) A person currently being treated for severe cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary systems, kidney and urinary systems, nervous system, psychiatric, infectious diseases, and malignancies (but can participate in the test at the discretion of the tester considering the subject's condition) 2) A person who has a history of surgery through general anesthesia within six months from the first visit ( Provided, That in the case of obesity surgery, within one year) 3) A person who has used subcutaneous injections (heparin, insulin) within one year from visit 1 4) Those who used the following drugs within one month (30 days) of visit - Obesity drugs (eating suppression, fat absorption inhibitors, GLP-1 receptor agonists, etc.) - Psychiatric drugs such as depression and schizophrenia - Beta blockers, diuretics, female hormones, male hormones, adrenal cortical hormones, thyroid hormones, immunosuppressants, proton pump inhibitors 5) Those who use the following health functional foods, etc. within three months of visit - Health functional foods that improve hyperlipidemia drugs, blood lipids and cholesterol {Omega 3 (maintained with EPA and DHA), ovarian harmonic maltodextrin, maintained with gamma-linolenic acid, lecithin, plant cholesterol, etc.} - Health functional foods/supplements for weight control purposes, herbal medicines, and weight control preparation foods 6) Uncontrolled hypertension patients (measured after systolic blood pressure of 140 mmHg or diastolic blood pressure of 90 mmHg or more, test subjects of 10 minutes of stability) 7) Diabetes patients with fasting blood sugar of 126 mg/dL or more or taking antidiabetic medications (such as oral hypoglycemic drugs) 8) Any person whose TSH is out of the normal range of the implementer 9) Those with eGFR less than 60 mL/min/1.73 m2 10) A person whose AST (GOT) or ALT (GPT) is more than three times the upper limit of the implementation engine 11) Alcohol drinkers exceeding the appropriate amount [male = 40 g/day, female = 20 g/day (WHO's daily alcohol intake standard)] 12) Excessive smokers (=20 cigarettes/day) 13) A person who is deemed unable to exercise due to musculoskeletal disorders 14) A person who has changed his/her weight by 10% or more or 5 kg or more within 3 months from visit 1 15) A person who participated in a commercial obesity program within three months from the first visit 16) A person who has given birth within 6 months as of visit 1, is pregnant, is nursing, or is planning to become pregnant during the self-application test period 17) A person who has a problem with the intake of food for human application tests due to severe gastrointestinal disorders 18) A person who is sensitive or allergic to food ingredients for this human application test 19) A person who has metal in the body due to surgery, etc 20) A person who has participated in other interventional clinical trials (including human application tests) within three months of the visit, or who plans to participate in other interventional clinical trials (including human application tests) after the start of this human application test 21) A person who finds the tester inappropriate due to other reasons

Design outcomes

Primary

MeasureTime frame
mount of body fat through DEXA

Secondary

MeasureTime frame
body weight;body mass index(BMI);thigh, arm, waist, hip circumference, waist/hip circumference;Body fat percentage and fat control through DEXA;visceral fat, subcutaneous fat, total abdominal fat area, visceral/subcutaneous fat area ratio through CT;blood lipid(Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride); a blood indicator(Free Fatty Acid, Ketone)

Countries

Korea, Republic of

Contacts

Public Contacthan sungho

Dong-A University

handsomdr@hanmail.net+82-51-240-5293

Outcome results

None listed

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