Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds - a Randomized, Placebo-controlled, Double-blind, Cross-over Study

Pharmanex1 个研究点分布在 1 个国家目标入组 27 人开始时间: 2016年8月1日最近更新: 2017年2月23日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Pharmanex
入组人数: 27
试验地点: 1
主要终点: Change from baseline in fecal volatile methyl sulfides at day 21, day 63, day 105

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of the study is to determine the effects of both an anthocyanin-rich polyphenol blend and an anthocyanin-rich polyphenol blend combined with a prebiotic blend on fecal microbiota metabolism (assessed by gas chromatograph - mass spectrometry (GC-MS) headspace analysis) and fecal microbiota composition (assessed by next generation sequencing).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Other
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Male or female of any race or ethnicity between 18 to 70 years of age, inclusive;
•Body mass index (BMI) between 20 - 32 inclusive;
•Non-smoking status;
•Willing to consume assigned dietary supplements for a total of 6 weeks;
•Have access to email and a digital camera or camera phone.

排除标准

•Age <18 or >70 years;
•BMI <20 or >32;
•Uncontrolled hypertension defined as diastolic blood pressure ≥95 mm Hg or systolic blood pressure ≥160 mm Hg;
•Self-reported presence of atherosclerotic disease and/or cardiopulmonary disease;
•Renal, hepatic, endocrine, gastrointestinal or other systemic disease;
•For women, pregnancy, breast feeding or postpartum less than 6 months;
•Current participation in another research study;
•Allergy to the components in the dietary supplement (inulin, fructooligosaccharide, blueberries, black currant, rice);
•History of drug or alcohol abuse;
•Use of antibiotics within the last 6 months;
•Use of prebiotics or flavonoid-containing dietary supplements within the last 30 days;
•Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence;
•Chronic use of over-the-counter medication which would interfere with study endpoints including NSAIDS, laxatives and antacids;
•Participating in or planning to begin a weight loss diet during the study period;
•Lifestyle or schedule incompatible with the study protocol;
•Other medical, psychiatric, or behavioral conditions that in the view of the principal investigator may present a safety hazard to the participant or interfere with study participation or the ability to follow the intervention protocol;
•Use of tobacco products.