JPRN-jRCT1091220210已完成Unknown
Efficacy trial and long-term safety confirmation test- Efficacy and long-term safety of the test food TK61406 ingested as a single dose, in a double-blind, parallel-group comparison to placebo. - PRT-TT-MF-ES -TK61406-01
Tokai Pickling Co.,Ltd. Yasufumi Ohba, Masataka Fujita, Mitsuru Satsukawa, Tetsuhiro Kawamoto, Mika Komura, Shoko Nishio, Tetsuya Iyoda,Hiroshi Ono0 个研究点目标入组 30 人开始时间: 2015年3月26日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 50age old（—）
- 性别
- All
入选标准
- •Target subjects must satisfy the following selection criteria.
- •1) Men and women aged more than 20 years, and less than 50 years, at the time of giving informed consent.
- •2) Persons of Japanese nationality, and clear Asian descent.
- •3) Persons who, during the screening period, are not using chronic or seasonal drugs or medical equipment, and are not undergoing rehabilitation therapy.
- •4) Persons who have freely given consent and have understood the purpose of the study.
- •5) Persons with a tendency for constipation or diarrhea.
- •Constipation: More than 2 days of constipation (consecutive or non-consecutive) during the screening period from -7 day to -1 day.
- •Diarrhea: More than 1 day of diarrhea within a period of 2 days during the screening period from -7 day to -1 day.
- •Persons classified as normal to 1 degree of obesity (BMI of less than 30.0 and more than 18.5) based on the new determination of obesity and diagnostic criteria 2011 of the Japanese Society for the Study of Obesity.
- •7) Blood pressure
- •Persons whose blood pressure is measured twice in the examination room, and falls in the range of normal to 1 degree of average blood pressure values in adults based on the hypertension treatment guidelines 2014 of the Japanese Society of Hypertension (systolic blood pressure: less than 159 mmHg, diastolic blood pressure: less than 99 mmHg)
- •8) Pulse rate
- •50 - 100 beats/minute
- •9) Body temperature
- •35.5 - 37.0 C
- •10) Persons not participating in excessive exercise
- •11) Persons not overeating
- •12) Participants who understand that clinical visits are mandatory during the study period
排除标准
- •The following exclusion criteria apply to subjects.
- •1) Persons who have used drugs continuously or occasionally during the screening period from -7 day to visit 0
- •2) Persons who have the following complications listed in the diagnostic criteria for obesity, based on the new determination of obesity and diagnostic criteria 2011 by the Japanese Society for the study of Obesity.
- •[Complications]
- •- Impaired glucose tolerance (type II diabetes, impaired glucose tolerance, etc.)
- •- Dyslipidemia
- •- High blood pressure (1 degree of hypertension excluded)
- •- Hyperuricemia, gout
- •- Coronary artery disease, including myocardial infarction, and angina pectoris
- •- Cerebral infarction, including cerebral thrombosis, transient ischemic attack
- •- Fatty liver (non-alcoholic fatty liver disease)
- •- Menstrual abnormalities, pregnancy complications (pregnancy-related hypertension syndrome, pregnancy-related diabetes, dystocia)
- •- Sleep apnea syndrome, obesity hypoventilation syndrome
- •- Orthopedic disease, including osteoarthritis (knee, hip) and deformation of the spine, lower-back pain
- •- Obesity-related kidney disease
- •3) Persons with gastrointestinal tract, liver, kidney, heart, or circulatory system disease.
- •4) Persons who have undergone gastrectomy, gastrointestinal suture surgery, or persons with history of major surgery of the gastrointestinal tract, intestinal tract resection, etc., except for polypectomy and appendectomy.
- •5) Persons with a history of cerebrovascular disease (except asymptomatic lacunar infarction)
- •6) Persons with tattoos
- •7) Persons with food allergies, hypersensitivity, or food idiosyncrasies
- •8) Persons with alcohol or drug dependency.
- •9) Persons who have participated in other clinical trials within 12 weeks (84 days) of giving informed consent.
- •10) Persons who have donated 400 ml of blood within 12 weeks (84 days), 200 ml of blood within 4 weeks (28 days), or a blood component (plasma or platelets) within 2 weeks (14 days) of giving informed consent.
- •11) Persons trying to conceive within the clinical study period.
- •12) Nursing or pregnant women.
- •13) Persons whose diagnosis required treatment of mental illness by a clinical investigator.
- •14) Persons who are unable to comply with administrative matters during the clinical study.
- •15) Persons who for other reasons are determined to be ineligible by the clinical investigator.
研究者
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