Optimizing the Bioavailability and Metabolism of Aronia Berry Polyphenols for Improving Gut Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Urine Creatinine Content
研究概览
简要总结
The objective of this study is to conduct a randomized cross-over dietary intervention among healthy adults to compare the bioavailability and the fecal polyphenol metabolites of intervention foods made with whole aronia berry powder, aronia berry extract, phospholipid-polyphenol (PLP), and a low-polyphenol control. 10 participants will be enrolled and can expect to be on study for up to 28 days.
详细描述
Inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis are two conditions of IBD that are characterized by chronic inflammation and damage of the gastrointestinal tract. In the United States alone, IBD are estimated to affect as many as 1.6 million people. IBD are associated with high morbidity, decreased quality of life, as well as substantial health care costs. IBD currently have no known cure, and treatment of IBD often requires the use of potent immunosuppressors which may lead to side effects or surgery.
Berries and prevention of chronic inflammation: Anthocyanins and other polyphenols are promising dietary agents to prevent and treat IBD by improving intestinal barrier dysfunction, inhibiting differentiation of pro-inflammatory T cells, reducing production of proinflammatory cytokines, and preventing oxidative stress. While preliminary studies are promising, translational human intervention studies are needed to refine delivery of polyphenol-rich foods and to confirm anti-inflammatory mechanisms.
Berries are rich dietary sources of polyphenols and essential nutrients. Polyphenol intake varies significantly by dietary patterns, but mean intake is estimated ~900 mg/day. Among berries, the polyphenol-dense aronia berry is one of the richest sources of fruit polyphenols.
Challenges associated with aronia berry consumption: In spite of its beneficial nutritional properties, the consumption of large amounts of whole aronia berry is not practical because of significant sorbitol and fiber content, which could lead to gastrointestinal discomfort for some individuals. Particularly, IBD patients often are required to limit fiber and whole fruit intake. The investigator's research group recently developed a novel method to extract polyphenols from fruit juice using food-grade lecithin which overcomes this problem.
The investigators hypothesize the resulting phospholipid-polyphenol (PLP) enriched material can improve the delivery of anthocyanins to the gut relative to a purified extract, and similar to that of whole berry. The aim of this study is to determine the comparative metabolism and bioavailability of aronia berry PLP intervention to extract, whole berry, and control food.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •willing to consume low-anthocyanin diets during the last days of wash-in and wash-out periods
- •willing to consume intervention foods during the sampling periods
- •willing to provide 24-hour urine and fecal samples during the sampling periods.
排除标准
- •people who do not consider themselves healthy
- •anyone with a self-reported previous diagnosis of a gastrointestinal disease (e.g. inflammatory bowel disease, irritable bowel syndrome)
- •undergoing current cancer treatment (i.e., chemotherapy, radiation therapy)
- •are pregnant, lactating, or trying to become pregnant
- •unwilling to consume study foods, or are allergic to sunflower, food colorants, berry ingredients, or any other component of the study foods.
- •taking medication that contraindicates grapefruit juice consumption
结局指标
主要结局
Urine Creatinine Content
时间窗: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
The urine creatinine content will be measured by a urinary creatinine colorimetric assay kit (Cayman Chemical).
Fecal Anthocyanin Concentration
时间窗: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
C18 solid-phase extraction (SPE) clean-up methods will be used to isolate anthocyanins and non-anthocyanin low-molecular weight polyphenol metabolites.
Urinary Anthocyanin Concentration
时间窗: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
C18 solid-phase extraction (SPE) clean-up methods will be used to isolate anthocyanins and non-anthocyanin low-molecular weight polyphenol metabolites.
Fecal Polyphenol Catabolite Concentration
时间窗: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
C18 solid-phase extraction (SPE) clean-up methods will be used to isolate anthocyanins and non-anthocyanin low-molecular weight polyphenol metabolites.
Urinary Polyphenol Catabolite Concentration
时间窗: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
Targeted analysis of free urinary polyphenol metabolites will be performed by ultra-high performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS).
次要结局
未报告次要终点
