Efficacy and Safety of Pepper seed extract (RPE) and Pepper seed complex extract (RPEC) on reducing body weight and body fat in overweight Female; A 12 week, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Efficacy and Safety of RPE and RPEC on reducing body weight and body fat in overweight female; A 12 week, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004078

Enrollment

120

Registered

2019-06-20

Start date

2018-05-10

Completion date

Unknown

Last updated

2019-07-17

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 : • Experimantal group I : Take 2 tablets twice a day before meal for 12 weeks (Pepper seed extract 1450mg/day) • Experimantal group II :Take 2 tablets twice a day before meal for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Adult men and women aged 20 or older and younger than 65 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

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) Persons with TSH of 0.1 µU/ml or greater than 10 µU/ml 5) A person whose creatine is more than twice the normal limit of the testing agency 6) A person whose AST (GOT) or ALT (GPT) is more than three times the normal upper limit of the testing agency 7) A person who complains of severe gastrointestinal symptoms such as heartburn and indigestion. 8) A person who have Allergy in pepper seed 9) A person who believes that the tester is unfit for other reasons

Design outcomes

Primary

Measure	Time frame
Body fat rate, body fat amount by DEXA(Dual-energy X-ray absorptiometry)	—

Secondary

Measure	Time frame
weight;Waist Circumference, Hip Circumferenc, Waist to Hip Ratio;Body Mass Index(BMI);Visceral Fat Area, Subcutaneous Fat Area, Taoal Fat Area,Visceral fat / Subcutanesou Fat Ratio by CT	—

Countries

Korea, Republic of

Contacts

Public ContactSangWook Song

The Catholic University of Korea, St. Vincent's Hospital

sswkoj@unitel.co.kr+82-31-249-8230

Outcome results