When a person takes extract of Gelidium elegans, it is study to evaluate the efficacy and safety

Double blind, randomized controlled study to evaluate the efficacy and safety of extract of Gelidium elegans

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003514

Enrollment

Registered

2019-02-15

Start date

2016-09-08

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 1 tablet of Gelidium elegans and placebo in a 1: 1 randomized dose and take 6 tablets once a day for 3 months.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 80 male and female adults aged 20 years or older who had a body mass index of 25-30 kg / m2 and measured 2) People who have not received medication for obesity within the last 3 months 3) Adults without diabetes 4) A voluntary written consent to participate in the trial

Exclusion criteria

Exclusion criteria: 1) Those who are taking medication for obesity within the last 3 months and during the clinical trial 2) Subjective assessment, mental illness that may affect medicines for clinical trials. Especially, psychosis, depression, etc. 3) Exceptions to the following laboratory test results which may affect the performance of the test are excluded. - A liver disease with AST (SGOT) / ALT (SGPT)> 3 times the upper limit of normal - a renal impairment with a creatinine level> 1.5 mg / dl - TSH levels greater than 10 4) Those who have been taking glucocorticoids within the last 3 months that may affect obesity 5) Drug abuse or history (including alcohol) 6) Severe disease history that can be recurred during or immediately after the clinical trial 7) Pregnant and lactating women. 8) In addition, if the researcher is found unable to participate in clinical research

Design outcomes

Primary

Measure	Time frame
Changes in body weight.;Changes in body fat mass measured by BMI.;Changes in body fat measured by DEXA.;Changes in body fat measured by abdominal CT.;Changes in body fat mass measured by bioimpedence	—

Secondary

Measure	Time frame
Comparison of changes in waist circumference at fasting;Comparing total cholesterol changes comparing insulin changes;Compare total cholesterol changes;Compare total cholesterol changes;Compare HDL-C changes;Compare Apo B-100 Changes;Compare glucose changes;Comparing insulin changes;insulin??? ??	—

Countries

Korea, Republic of

Contacts

Public Contactjunghwa lee

Kyung Hee University Hosipital at Gangdong

liungh@naver.com+82-2-440-7058

Outcome results