Effects of Pomegranate Extract on Intestinal Flora
关键词
抽象
描述
At screening, informed consent and health insurance portability and assurance (HIPAA) authorization will be reviewed and signed. A medical history will be obtained. If criteria for enrollment are satisfied, a fasting blood sample will be collected for a comprehensive metabolic panel, and blood count. Results will be reviewed by the study physician for compliance to inclusion and exclusion criteria. The screening visit will also include a review of foods to avoid during run-in and study participation. Once lab results from the screening visit come back and are determined to be satisfactory for inclusion, the subject will be called and instructed to start dietary restrictions. The first stool collection (Day -1) will occur after two weeks of dietary compliance.
Day -1: Subjects will be asked to collect an entire stool and store it in a cooler filled with ice packs, along with a collection container until delivery to the lab within 24 hours.
Day 1: Subjects will take the 1st dose of POMx and be given a container for collecting their urine for 24 hours and asked to refrigerate this as the urine is collected. This urine will be used to determine the presence of urolithin A and whether they are "responder or non responder". Participants will be asked to consume 1 POMx capsule daily and to abstain from consuming pomegranates, walnuts, or polyphenol-rich foods or juices drawn from a list.
Day 27: Subjects will collect one entire stool and place in the provided cooler filled with ice packs for storage of the stool sample until delivery to the lab within 24 h. Urine collection will start at 8am after the morning dose of POMx and last until 8 am the day of clinic visit.
Day 28: Stool and urine sample will be collected. The stool sample collected at home (within the prior 24 hours) will be returned on this day. Blood sample will be collected. Compliance will be assessed by pill count. Safety and tolerance data will be collected.
日期
| 最后验证: | 08/31/2019 |
| 首次提交: | 02/17/2015 |
| 提交的预估入学人数: | 02/23/2015 |
| 首次发布: | 02/24/2015 |
| 上次提交的更新: | 09/17/2019 |
| 最近更新发布: | 10/01/2019 |
| 首次提交结果的日期: | 10/03/2018 |
| 首次提交质量检查结果的日期: | 08/13/2019 |
| 首次发布结果的日期: | 09/18/2019 |
| 实际学习开始日期: | 09/30/2012 |
| 预计主要完成日期: | 06/30/2013 |
| 预计完成日期: | 06/30/2013 |
状况或疾病
干预/治疗
Dietary Supplement: PomX
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: urolithin excretors The excretor status will be determined by analysis for urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample will be obtained before administering the extract. | |
| Active Comparator: non excretors The excretor status will be determined by analysis for urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample will be obtained before administering the extract. |
资格标准
| 有资格学习的年龄 | 20 Years 至 20 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. Age 20-50 years of age at screen. 2. In good health 3. Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent. Exclusion Criteria: 1. Any history of gastrointestinal disease except for appendectomy 2. Any use of antibiotics or laxatives during the 2 months prior to study enrollment. 3. Any subject with a history of diabetes mellitus, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP>160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination. 4. Any subject consuming pre- or probiotics 5. Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator. 6. Any subject who currently uses tobacco products or has used tobacco products within the last year. 7. Any subject who is unable or unwilling to comply with the study protocol. |
结果
主要结果指标
1. Change in Percentage of Total Microflora Between Urolithin Excretors and Non-excretors [4 weeks]
