A 12 week, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Tomato vinegar(TV-01) on reducing body weight and body fat of overweight subjects
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0002083
- Lead Sponsor
- OTTE Confectionery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1)Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial.
2) Male and female subjects between 20-65years of age inclusive
3)BMI of 25.0-29.9kg/m2
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)
2) The patient who take the medicine that can affect the state of weight change (uptake inhibitors, appetite suppressant, Antipsychotics hydragogue, contraceptives, steroid, and female sex hormon) within recent 1 months.
3) subject for uncontrolled hypertension, diabetes mellitus, thyroid disease (If that patient's clinical status is stable, they can participate in the clinical trial in the sight of investigator).
4)Serum creatinine = 2 times the upper limit of normal.
5)Serum AST(Aspartate aminotransferase)/ALT(Alanine aminotransferase) = 3 times the upper limit of normal.
6) Subjects who complain gastrointestinal symptoms such as heartburn, dyspepsia
7) Subjects with CNS(central nervous system) disorder(depressive disorder, schizophrenia, alcoholism, drug addiction).
8)Subjects with the musculoskeletal disorders or restricted physical activity.
9)Allergy or hypersensitivity in the Ecklonia cava
10) Participation in commercial diet program within the 3 months prior to screening.
11)Participation in any clinical trail within the 1 month prior to screening or have a plan to participate in other clinical trial.
12)Woman who are pregnant of lactating or planning to pregnant
13)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 Chainge in fat percentage(by Dual Energy X-Ray Absorptiometry, DEXA)
- Secondary Outcome Measures
Name Time Method Waist circumference, Hip circumference, waist-hip ratio(WHR) ;Fat mass, Fat Free Mass(by Dual Energy X-Ray Absorptiometry, DEXA) ;Body weight , Body mass index(BMI) ;Mesenteric fat area, Subcutaneous fat area, Total abdominal fat area, Mesenteric fat area/Subcutaneous fat area(by CT) ;Blood Lipid;Adverse Event,complete blood cell count,urinalysis,electrocardiography