To evaluate detoxification and body fat mass decrease effect and safety of Wellnessup® diet: 4-weeks, Clinical trial
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0003002
- Lead Sponsor
- Chonbuk National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- 45
1) Women over 19 years old and under 49 years old at the time of screening.
2) A person with a BMI between 23.5 and 30 kg/m2 at the time of screening.
3) The person who has heard and fully understood the full explanation of this human factors testing, and has agreed to voluntarily decide to participate and comply with the cautions.
1) A person who has lost more than 10 percent of weight within three months of screening.
2) Who has taken a medication or a health function food product associated with detoxification or weight loss within one month of screening.
3) Severe clinical attention is given to acute or chronic cardiovascular system, endocrinology, immune system, respiratory system, cold blood meter, kidney and urinary system, musculoskeletal system, inflammatory disease, and others.
4) There are people with gastrointestinal conditions (such as Cronic's disease) who can be affected by the human body's applied test, and people with gastro-related operations (except for simple appendix protrusion subtractomization or hernia).
5) Those who overreact about the ingredients in the human diet.
6)Who has continuously administered antipsychotics within six months of screening
7) A suspected drug abuse or medical history
8) Who is constantly drinking alcohol that has exceeded 21 units/week or has a history of alcohol abuse
9) Who shows the following in a diagnostic examination medical examination
? Serum AST, ALT > three times of the reference range upper limit
? Serum creatinine > 2.0 mg/dL
10) Who has participated in other human body applications within two months of screening
11) Menopause (non-month-free for more than 12 months) or menopause (non-precision for more than three consecutive months) women.
12) A woman who is pregnant or is suckling or has plans to be pregnant during the duration of this human body application testing.
13) Women who became pregnant with pregnancy agreed not to use effective contraception (condoms, birth control masks, intrauterine contraception, or if a male partner underwent vasectomy) during the trial period.
14) A person who has determined that a tester is unsuitable for participating in human factors testing for reasons other than diagnostic testing medical examination results.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Analyzed harmfulness element of hair
- Secondary Outcome Measures
Name Time Method Antropometric(weight, body mass index, body fat mass, percent body fat, lean body mass, waist circumference, hip circumference and waist-hip circumference ratio.);Lipid profile (Total cholesterol, Triglyceride, LDL-cholestrol, HDL- cholesterol, Apo A1, Apo B);Glucose profile (fasting blood glucose, fasting insulin, HbA1c, HOMA-IR);Inflammatory factors (hs-CRP, ESR);Uric acid;Gamma-Glutamyl Transferase (GGT);Vitamin D;Fatty liver;Urine Organic Acid Test (ß-Hydroxybutyrate, Isocitrate, Methylmalonate, a-Ketoisocaprate, a-Hydroxybutyrate (AHB), 3,4-Dihydroxyphenylpropionate (DHPP), 8-Hydroxy-2-deoxyguanosine (8-OHdG));World Health Organization Quality of Life-BREF;subjective/objective adverse event;Results of laboratory test;Vital sign (systolic/diastolic blood pressure, pulse)