KCT0005913尚未招募未知
A human study for evaluating effectiveness and safety of GPX on gut immunity
Ewha Womens University0 个研究点目标入组 116 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 64(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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.
- •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
研究者
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