The Efficacy and Safety of Phaeodactylum tricornutum extract on reducing body weight and body fat of overweight or obesity subjects
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0003979
- Lead Sponsor
- H Plus Yangji Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1) Subjects between 20 ~65 years of age
2) BMI of 25.0-31.9 kg/m2
3) Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial.
1) The Patients with severe cerebrovascular disease, cardiac disease (If that patient's clinical status is stable, they can participate in the clinical trial according to investgator) within recent 6 months.
2) Subejects who have taken drugs such as absorption inhibitors and apetite suppressants, health functional foods/supplements related to obesity improvement, psychiatric drugs such as drpression, beta blockers, diuetics, birth control pills, steroids, female hormone within recent a month.
3) Subjects with systolicBP = 160 mmHg or diastolicBP = 100 mmHg(Subjects measure after 10 minutes stabilization)
4) Subjects with diabetes(use of hypoglycemic agent or insulin)or fasting blood glucose = 126 mg/dL or random blood glucose = 200 mg/dL.
5) Subjects with TSH = 0.1 µU/ml or TSH = 10 µU/ml.
6) Creatinine is more than twice the normal upper limit
7) AST(GOT) or ALT(GPT) is more than three times the normal upper limit
8) Subjects who have difficulty in taking test materials because of the severe gastrointestinal disturbances
9) Subjects who are admitted to hospital, medication or rehabilitation due to alcohol, heart disese, central nervous disorder
10) Those who are judged to be unable to exercise due to musculoskeletal disorders
11) Subjects who loss weight wihtin recent a month
12) Those who participated in the commercial obesity program within the last 3 months
13) Those who participated or will participate in other clinical trials within the past month.
14) A person who is pregnant or who has a pregnancy plan during the period of the test
15) Those who are sensitive or allergic to foods related to green algae, microalgae and brown algae.
16) Subjects which in the opinion investigator could affect preclude evluation of response
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body fat percentage, fat mass through DEXA
- Secondary Outcome Measures
Name Time Method Body weight;waist circumference, hip circumference, waist/hip circumference ratio;body mass index;Fat content through DEXA;Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride, Adiponectin, Leptin, hs-CRP;Visceral fat area, subcutaneous fat area, total abdominal fat area, visceral/subcutaneous fat area through CT