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A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of RPE on reducing body fat

A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of RPE on reducing body fat

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0011072
Enrollment
100
Registered
2025-09-26
Start date
2024-01-16
Completion date
Unknown
Last updated
2025-11-10

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 : Test(RPE) or Placebo Tablet, 1000 mg per tablet, orally administered once daily for 12 weeks

Sponsors

Kyung Hee University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults aged 19 to 65 2) Those with a BMI of 25 kg/? or more but less than 30 kg/? 3) Individuals who voluntarily agreed to participate in the study and signed the informed consent form for the study

Exclusion criteria

Exclusion criteria: 1) Those who have lost 10% or more of their body weight in the three months prior to the screening visit 2) Those who have undergone surgery or other procedures for weight loss within the year prior to the screening visit 3) Those who have participated in a commercial or non-commercial weight loss program within the three months prior to the screening visit 4) Those who have continuously taken medications or health functional foods that affect weight or body fat loss within the month prior to the screening visit -Medications: Anti-obesity drugs, hypoglycemic agents, insulin preparations, diuretics, antidepressants, corticosteroids, antiepileptics, birth control pills, and other Medications that affect energy metabolism, blood sugar, appetite, gastrointestinal activity, or body weight 5) Those with a fasting blood sugar level of 126 mg/dL or higher, a diagnosis of diabetes, or those taking oral hypoglycemic agents or insulin preparations 6) Those with a systolic blood pressure of 160 mmHg or higher or a diastolic blood pressure of 100 mmHg or higher (If diagnosed with hypertension, check your blood pressure while taking medication) 7) Those whose AST, ALT, or creatinine values exceed two times the normal range 8) Those taking medication for dyslipidemia 9) Those diagnosed with autoimmune disease, thyroid disease, severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina, myocardial infarction, heart failure, arrhythmia, etc.), mental illness, or central nervous system disorders 10) Those diagnosed with chronic gastrointestinal disorders, eating disorders, or alcoholism 11) Those diagnosed with or treated for cancer within the past five years 12) Those who have undergone major surgery within the past six months 13) Pregnant or lactating women, or those planning to become pregnant within the next six months 14) Those taking oral contraceptives 15) Those with hypersensitivity to the test product or its ingredients, or those with allergies to specific ingredients 16) Those who participated in another clinical trial or human application study within the month prior to participating in the study 17) Those who cannot read or have limited reading ability 18) Other individuals deemed unsuitable for research participation by the research director

Design outcomes

Primary

MeasureTime frame
Change in body fat (measured by dual-energy x-ray absorptiometry)

Secondary

MeasureTime frame
Body mass index (BMI), weight ;Blood indicators (adiponectin, leptin, lipid profile (TG, TC, LDL-C, HDL-C));blood insulin concentration;blood insWaist-to-hip ratio (WHR), waist circumference, hip circumferenceulin concentration

Countries

Korea, Republic of

Contacts

Public ContactMinkyung Bok

Research Institute of Medical Nutrition

yoccobbong03@naver.com+82-2-969-7715

Outcome results

None listed

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