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Randomized, Double Blinded, Placebo Comparative Human Application Trial to Evaluate the Functionality and Safety against body fat reduction of Salacia Extracts in Overweight or Obese Adults

Randomized, Double Blinded, Placebo Comparative Human Application Trial to Evaluate the Functionality and Safety against body fat reduction of Salacia Extracts in Overweight or Obese Adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010387
Enrollment
150
Registered
2025-04-08
Start date
2023-03-03
Completion date
Unknown
Last updated
2025-05-07

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 : The main characteristic of the test food is salacia extract, and the properties and formulations are hard capsules. The content is 450 mg per capsule, and the raw material and mix

Sponsors

Semyung University Oriental Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Men and women between the ages of 19 and under 60 2) Subjects with body mass index (BMI) of 25 kg/m2 or more and less than 30 kg/m2 3) Subject who agreed to participate in this study and voluntarily signed the written consent

Exclusion criteria

Exclusion criteria: 1) Subjects with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina, myocardial infarction, heart failure, and arrhythmia requiring treatment) or malignant tumors within the last 6 months (However, subjects with a history of cerebrovascular disease or heart disease but clinically stable may participate in the trial at the discretion of the researcher) 2) Subjects who have been taking weight-affected drugs (fat absorption inhibitors and appetite inhibitors, health foods/supplements related to obesity improvement, depression, etc.) within the last month; beta blockers, diuretics, contraceptives, steroids, and female hormones) 3) Obesity or overweight subjects due to endocrine diseases such as hypothyroidism and Cushing's syndrome 4) Subjects who are undergoing continuous treatment or medication due to gastrointestinal disorders (such as gastric ulcer, chronic digestive disorders, irritable bowel syndrome, etc.) 5) Subjects who have a history of psychological significance or are currently suffering from a medical condition (e.g., schizophrenia, epilepsy, anorexia, hyperorexia etc.), or a history of alcohol and other substance abuse 6) Subjects deemed unable to exercise due to musculoskeletal disorders 7) Diabetes patients with fasting blood sugar of 126 mg/dl or random blood sugar of 200 mg/dl or more or oral hypoglycemic agents or insulin 8) Patients with uncontrolled hypertension (blood pressure greater than 160/100 mmHg, and measurement criteria after 10 minutes of stabilization in subjects) 9) Subjects taking medication for dyslipidemia 10) Subjects whose AST (GOT) or ALT (GPT) is more than 2.5 times the normal upper limit of the testing institution 11) Subjects who have more than twice the normal upper limit of the creatinine testing institution 12) Subjects who have lost more than 5% of their weight within the last three months 13) Subjects who have participated in a commercial obesity program within the last three months 14) Subjects who have participated in the same examination and have not passed 3 months 15) Subjects who are pregnant or breastfeeding or plan to conceive during the human body application test period 16) Subjects who have allergic reactions to food for human application testing 17) Subjects deemed unsuitable by the researcher due to other reasons

Design outcomes

Primary

MeasureTime frame
Changes in body fat mass (g) and body fat percentage (%) using DEXA

Secondary

MeasureTime frame
Changes in fat mass (g) using DEXA;Changes in body fat mass (g), body fat percentage (%) and fat percentage (g) by area(Arms, legs, trunk, Android, Gyroid) using DEXA;Changes in the ratio of total fat area, subcutaneous fat area, visceral fat area, visceral fat area/subcutaneous fat area (VSR) measured using abdominal CT;a change in weight;changes in body mass index;Changes in waist circumference, hip circumference, waist circumference/hip circumference ratio;changes in blood lipid levels(Total Cholesterol, LDL-Cholesterol, Triglyceride, HDL-Cholesterol);Changes in Leptin and Adiponectin, fasting blood glucose, fasting insulin, and HOMA-IR;an abnormal reaction;Laboratory examination (hematologic examination, hemochemical examination, urine test);Vital signs (SBP, DBP, pulse, body temperature)

Countries

Korea, Republic of

Contacts

Public ContactJeong Eun Lee

Semyung University Oriental Medicine Hospital

happyrabbit07@naver.com+82-43-649-1873

Outcome results

None listed

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