Study of the Effect of Fruit/Vegetable Based Supplementation on Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Colonic Flora Composition
研究概览
简要总结
This is a 4 ½ week study with 20 healthy subjects (including a 2 week run-in ) . Subjects will be taking vegetable/fruit juice supplementation for 3 days. Blood, urine and stool samples will be collected at baseline, day 4 and day 17. The purpose of the study is to determine the effects of fruit/vegetable supplementation on colonic flora.
详细描述
A total of 20 subjects will be recruited from The UCLA Center for Human Nutrition/Clinical Trials Unit database, print and/or radio advertisements, UCLA campus wide e-mail, the clinicaltrials.gov website, and flyers posted on campus and in the community.
Interested persons will call a telephone number dedicated to the study where they will be instructed to leave their name and phone number. These individuals will be contacted by a study staff member, who will briefly describe the study and answer any questions to ascertain interest. If the individual is interested they will be asked to complete a brief pre-screen form over the telephone to establish eligibility. Individuals who remain interested will be invited for a screening visit. Pre-screen surveys for those not eligible will be shredded.
At screening, informed consent and HIPAA authorization will be reviewed and signed prior to any procedures being done, a medical history will be obtained. If subjects are healthy by medical history the following procedures will be conducted:
- a fasting blood sample will be collected for routine safety labs (CBC and Chemistry Panel)
- complete medical and medication history
- brief physical examination (including vital signs, height and weight)
- Dietary instruction to limit consumption of <3 servings of fruit and vegetables, vitamins and antibiotics
- Dispense materials to collect fecal sample
Results will be reviewed by the study physician for compliance to inclusion and exclusion criteria and the subject will be collected and instructed whether or not they are eligible and should proceed with the stool collection after 2 weeks of dietary compliance. Once the collection is obtained subjects will be asked to return to the clinic in 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-50 years of age at screen
- •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.
排除标准
- •Any subject with a history of diabetes mellitus on medications, hyperlipidemia on medications, 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.
- •Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
- •Any subject who currently uses tobacco products.
- •Any history of gastrointestinal disease except for appendectomy
- •No antibiotics or laxatives use during the 2 months before the study.
- •Any allergies to nuts
- •Any subject who is unable or unwilling to comply with the study protocol.
研究组 & 干预措施
pressed juice 6 bottles
Subjects will consume pressed juice daily for 3 days.
干预措施: Pressed Juice (Dietary Supplement)
结局指标
主要结局
Change in Colonic Flora Composition
时间窗: baseline and day 4
Changes in microbial count (%) were calculated as the values at day 4 minus the values at baseline
次要结局
未报告次要终点
研究者
Zhaoping Li
Professor of Medicine
University of California, Los Angeles