To Determine the Metabolomics and Microbiome Changes After Cranberry Juice Consumption Among Young Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- The correct rate of identifying cranberry consumers and non-cranberry consumers by previously established multivariate statistical models of PLS-DA/OPLS-DA combined with UHPLC-Q-Orbitrap-HRMS.
研究概览
简要总结
The compliance of participants in cranberry related clinical trial is poor due to the bitterness and astringency of cranberry products. There is a pressing need for an effective approach to verify participant compliance. The PLS-DA (Partial Least Squares Discriminant Analysis) /OPLS-DA (Orthogonal Partial Least Squares Discriminant Analysis) models established from the investigator's previous study provide an opportunity to identify cranberry juice consumers. In this blinded, placebo-controlled, cross-over study, investigators hypothesize that the established statistical models of PLS-DA (Partial least squares discriminant analysis) /OPLS-DA (Orthogonal partial least squares discriminant analysis) can identify cranberry juice consumers and non-consumers by analyzing the metabolomic changes in blood and urine among young women. In order to further explore the function of cranberry, microbiome profile will also be compared between cranberry juice consumption and placebo consumption after long-term treatment. Another comparison of metabolomic changes between short-term treatment and long-term treatment will be made to further identify candidate biomarkers of cranberry consumption and explore the correlation between acute effects and chronic effects of cranberry.
详细描述
Consumption of cranberry juice has been related to the prevention of urinary tract infection. However, due to the bitterness and astringency of cranberry products, the compliance of participants in cranberry related clinical trial is poor, which makes it difficult to further study the function of cranberry juice. Accordingly, there is a pressing need for an effective approach to verify participant compliance. In the previous study, plasma and urinary metabolome in young women following cranberry juice consumption have been investigated using a global UHPLC (Ultra high-performance liquid chromatography) -Q-Orbitrap-HRMS (High-resolution mass spectrometry) approach. PLS-DA (Partial least squares discriminant analysis) analyses showed that both plasma and urinary metabolome in young women were altered following cranberry consumption compared to baseline and apple juice consumption. Cranberry juice consumption caused a greater excretion of both exogenous and endogenous metabolites. These metabolites have been identified as candidate biomarkers for cranberry juice consumption. The established PLS-DA (Partial least squares discriminant analysis) /OPLS-DA (Orthogonal partial least squares discriminant analysis) models provide an opportunity to identify cranberry juice consumers.
It is unknown whether cranberry juice consumption influences gut microbiota profile in human. But several studies suggested that a polyphenol-rich diet improves gut microbiota profile. The previous in vitro study with human gut microbiota indicated that microbial catabolism of A-type cranberry procyanidins produced metabolites with different profiles and structures compared with those from B-type procyanidins.
Understanding microbiome change in human gut will enable the investigators to correlate and explain metabolome changes in the urine and blood, and also will explain the health benefits of cranberries.
With all the samples will be collected in this study, the metabolomics changes between short-term cranberry juice treatment (3days) and long-term treatment (21days) can be compared. Since the urinary tract protection effects of cranberry juices are often associated with chronic consumption, more metabolomic changes are expected to be identified by a long-term study.
Research Plan:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal BMI (18.5-25)
- •Body weight ≥110 pounds
排除标准
- •Gastrointestinal disorders
- •Urological diseases
- •Metabolic disorders
- •Pregnancy
- •Previous use of antibiotics or probiotics.
研究组 & 干预措施
Placebo juice consumption
participants in this arm will be provided placebo juice to consume for 21 days in total
干预措施: Placebo juice (Other)
Cranberry juice consumption
participants in this arm will be provided cranberry juice to consume for 21 days in total
干预措施: Cranberry juice (Other)
结局指标
主要结局
The correct rate of identifying cranberry consumers and non-cranberry consumers by previously established multivariate statistical models of PLS-DA/OPLS-DA combined with UHPLC-Q-Orbitrap-HRMS.
时间窗: up to 6 months
次要结局
- Number of healthier microbial community in the stool sample after short-term (3 days) and long-term (21 days) cranberry juice consumption.(3 days and 21 days)
- The change in quantity of endogenous and exogenous metabolites in blood/urine after 3-day consumption and 21-day consumption of cranberry juice comparing to baseline blood/urine sample(3 days and 21 days)