Human study for investigating the effects of chronic intake of Ecklonia cava on body fat level and related metabolism in obese adults

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0001074
• Lead Sponsor: Ewha Womans University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1) Subject who voluntarily agree to participate and signs informed consent form
2) 20 years= Age <50 years
3) 25kg/m2= BMI =30kg/m2
4) 1mg/L= blood CRP =10mg/L
5) Skeletal muscle index =39.8% (male), 34.1% (female)
6) Subject who comply with dietary/exercise guidlines for intervention period

Exclusion Criteria

1) Administration of medicine that affect body weight : appetite suppressants/accelerators, hypotensive agents, contraceptive, steroid drug, TCA drug, postmenopausal hormone medicine, laxatives, antidepressant et al.
2) Participation in commercial obesity program or experience of calorie-restricted theraphy within three months before the first visit
3) Subject who has consumed of dietary supplements for body weight control, probiotics, oriental medicine or has been treated with pharmaceutical drug within one month before the first visit
4) Subject with body weight change more than 3kg within three months before the first visit
5) Subject with surgical experience (esophagogastroplasty, enterectomy, et al.) for weight loss
6) Subject with experience of severe depression (hospital treatment or attempt case)
7) Subject with experience of epilepsy or eating disorder
8) Subject with following diseases:
- Hypertension
- Diabetes(use of hypoglycemic agent) , fasting blood glucose= 180mg/dl or HbA1c= 8.0
- Liver dysfunction
- Renal dysfunction
- Hyperthyroidism or hypothyroidism
- Malignant tumor, heart diesase, lung diseases, asthma, nerve/mental disorder, stomach and intestines disease, hepatitis, Cushing's disease, tuberculosis
9)Subjects with hypersensitivity to test materials
10) Participation in other human study within one month before the first visit
11) Pregnant or lactating women
12) Any condition that the principal investigator believes may put the subjects at undue risk

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maker of fat level and related metabolism

Secondary Outcome Measures

Name	Time	Method
Maker of safety, etc.