Effects of Pomegranate Extract on Intestinal Flora
Кључне речи
Апстрактан
Опис
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.
Датуми
| Последња верификација: | 08/31/2019 |
| Фирст Субмиттед: | 02/17/2015 |
| Предвиђена пријава послата: | 02/23/2015 |
| Прво објављено: | 02/24/2015 |
| Послато последње ажурирање: | 09/17/2019 |
| Последње ажурирање објављено: | 10/01/2019 |
| Датум првог достављања резултата: | 10/03/2018 |
| Датум првог подношења резултата КЦ: | 08/13/2019 |
| Датум првог објављивања резултата: | 09/18/2019 |
| Стварни датум почетка студије: | 09/30/2012 |
| Процењени датум примарног завршетка: | 06/30/2013 |
| Предвиђени датум завршетка студије: | 06/30/2013 |
Стање или болест
Интервенција / лечење
Dietary Supplement: PomX
Фаза
Групе руку
| Арм | Интервенција / лечење |
|---|---|
| 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. |
Критеријуми
| Узраст подобан за студирање | 20 Years До 20 Years |
| Полови подобни за студирање | All |
| Прихвата здраве волонтере | да |
| Критеријуми | 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. |
Исход
Примарне мере исхода
1. Change in Percentage of Total Microflora Between Urolithin Excretors and Non-excretors [4 weeks]
