KCT0003979Recruiting未知
Efficacy and Safety of Phaeodactylum tricornutum extract on reducing body weight and body fat of overweight or obesity subjects; A 12 week, Randomized, Double-blind, Placebo-Controlled Clinical Trial
H Plus Yangji Hospital0 sites100 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 20(Year) to 65(Year) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Investigators
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