A human study for evaluating effectiveness and safety of GPX on gut immunity
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0005913
- Lead Sponsor
- Ewha Womens University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 116
1) Subject who voluntarily agree to participate and signs informed consent form
2) Age more than 20-year-old and less than 65 years old
3) BMI = 23 kg/m2
4) Subject with a waist circumference of Male = 90 cm, Female = 85 cm
5) Subject who has had diarrhea or constipation symptoms at least once a week in the past month
1) Subjects with the following diseases:
- Intestinal diseases (Crohn's disease, colon cancer, celiac disease, inflammatory bowel disease IBD, etc.)
- Patients with a history of lactose intolerance, gastrointestinal surgery (gastrointestinal duct surgery, etc.)
- Thyroid disease, multiple sclerosis, spinal trauma, Cushing's syndrome, hyperlipidemia, cerebrovascular disease, cardiovascular disease, etc.
- Severe central nervous system disorders requiring hospitalization or medication (dementia, Parkinson's disease, etc.)
2) Those who fall under the following
- Consistent intake of antibiotics for more than a week within 4 weeks before the first visit
- Temporarily took nonsteroidal anti-inflammatory drugs, corticosteroids, an immunosuppressive drug, etc. within 2 weeks before the first visit, or continuously took the drug within 12 weeks of before the first visit.
- Antibacterial treatment within 6 weeks before the first visit.
- Ingestion of appetite suppressants/stimulants, antidepressants, diuretics/beta-blockers, contraceptives, hormone drugs, etc. within 4 weeks before the first visit
3) High intake of antioxidant nutrients and dietary fiber
4) Continue to consume products containing ingredients that affect intestinal health within 4 weeks before the first visit.
5) Performing regular high-intensity exercise continuously.
6) Participated in a commercial obesity program or received a calorie restriction diet treatment within 12 weeks before the first visit.
7) Over 5% weight change within 12 weeks before the first visit.
8) Smoker
9) Heavy drinker
10) Hypersensitivity to the ingredients contained in the study product, or there is a severe food allergic reaction experience.
11) Subject who has difficulty to handle smartphone or computer
12) Participation in other human studies within 1 month before the first visit
13) Planning to be pregnant, Pregnant, or lactating women
14) Any condition that the principal investigator believes may put the subjects at under risk
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intestinal health improvement indicator
- Secondary Outcome Measures
Name Time Method Clinical pathology indicator(vital signs, clinical laboratory test);Clinical pathology indicator(adverse events)