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Efficacy and safety of ASE(Aster spathulifolius Maxim. extract) on reducing body weight and body fat in overweight subjects

Efficacy and safety of ASE(Aster spathulifolius Maxim. extract) on reducing body weight and body fat in overweight subjects; A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002664
Enrollment
80
Registered
2018-01-26
Start date
2017-10-30
Completion date
Unknown
Last updated
2019-03-11

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 650 mg / tablet of Aster spathulifolius Maxim. extract (350 mg / tablet) and control group (Placebo) twice a day for 12 weeks.

Sponsors

Newtree
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Adult men and women aged 20 or older and younger than 70 years (2) Those with a body mass index (BMI) of 23 kg / m2 or more and less than 30 kg / m2 (3) A person who agrees to participate in the Applicable Human Body Examination and who has voluntarily signed a written consent form (or legal representative)

Exclusion criteria

Exclusion criteria: (1) Subjects with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment) within the last 6 months If the subject has a history but is clinically stable, he or she can participate in the test by the examiner's judgment.) (2) Uncontrolled hypertension patients (blood pressure of 160/100 mmHg or more, after 10 minutes of test subjects) (3) Diabetic patients taking fasting blood glucose levels greater than 126 mg / dl, randomized blood glucose levels greater than 200 mg / dl, or taking oral hypoglycemic agents or insulin (4) TSH not more than 0.1 uU / ml or not less than 10 uU / ml (5) Creatinine is at least twice the normal upper limit of the testing laboratory (6) AST (GOT) or ALT (GPT) is at least three times the normal upper limit of the test laboratory. (7) People who complain of severe gastrointestinal symptoms such as heartburn and indigestion (8) Drugs that affect body weight within the past month (including absorption inhibitors and appetite suppressants, health functional foods / supplements related to obesity improvement, psychiatric drugs such as depression, beta blockers, diuretics, birth control pills, steroids, Who are taking medicines to treat hyperlipidemia (9) Those who participated in the commercial obesity program within the last 3 months (10) Have participated or planned to participate in other clinical trials within the past month (11) Those who are admitted to hospital, medication or rehabilitation due to heart disease, central nervous disorder, etc. through medical history (12) A person who is judged to have trouble with the test due to excessive alcohol consumption (13) Those who are judged to be unable to exercise due to musculoskeletal disorders (14) A person who is pregnant or who has a pregnancy plan during the period of the test (15) Any person who is found to be unsuitable for any other reason

Design outcomes

Primary

MeasureTime frame
Changes in body fat through DEXA(Dual Energy X-Ray Absorptiometry) after 12 weeks compared to baseline;Changes in visceral fat area, subcutaneous fat area, total abdominal fat area, visceral / subcutaneous fat area ratio by CT after 12 weeks compared to baseline

Secondary

MeasureTime frame
Body weight, body fat mass through bio-impedance devices;Waist circumference, hip circumference, waist / hip circumference ratio;body mass index;Body fat through DEXA(Dual Energy X-Ray Absorptiometry) ;Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride;hs-CRP, Fasting insulin, HOMA-IR, HOMA-ß;leptin, adiponectin, TNF-a, IL-6

Countries

Korea, Republic of

Contacts

Public ContactJEONG KYUNG

Kyung Hee University Hosipital at Gangdong

jik1016@naver.com+82-2-440-6126

Outcome results

None listed

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