An interventional study of Whole Aronia Berry Powder Applesauce and Aronia Berry Extract Applesauce in Gut Health, Metabolism and Polyphenols, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-31.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Basic science
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.
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.
Consumption of Intervention Foods: In the morning of the day of each intervention and sampling period (days 6, 13, 20, and 27 i), participants will be asked to visit the Bolling Laboratory at the Department of Food Science fasted. Participants will then be asked to empty their bladders and then consume one serving of the applesauce (≤200 g). Then, in the next 24 h, participants will be asked to only consume commercially available frozen and shelf-stable low-polyphenol meals and snacks provided by study personnel. Insulated bags will be provided to participants for transport of frozen meals. The low-polyphenol diet and snacks will consist of dairy products, meat, low-phenolic snacks (e.g., banana, potato chips) and starch sources (e.g. white bread, rice, and plain bagels). Water will be available to participants over the time course, and its intake is not restricted.
University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
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Exclusion Criteria:
Dietary Supplement: Whole Aronia Berry Powder Applesauce
Dietary Supplement: Aronia Berry Extract Applesauce
Dietary Supplement: Phospholipid-Polyphenol Applesauce
Other: Low-Polyphenol Control Applesauce
The food will be designed to be a berry-flavored applesauce. The food will include applesauce, sweeteners, citric acid, natural flavors and food colorants. Applesauce A will additionally contain whole aronia berry powder (Milne MicroDried, Nampa, ID).
The food will be designed to be a berry-flavored applesauce. The food will include applesauce, sweeteners, citric acid, natural flavors and food colorants. Applesauce B will additionally contain aronia berry extract (Artemis International, Fort Wayne, IN).
The food will be designed to be a berry-flavored applesauce. The food will include applesauce, sweeteners, citric acid, natural flavors and food colorants. Applesauce C will additionally contain PLP which will be prepared with commercially-available aronia juice concentrate (Greenwood Associates, Niles, IL) and soy lecithin (Whole Foods, Austin, TX).
The food will be designed to be a berry-flavored applesauce. The food will include applesauce, sweeteners, citric acid, natural flavors and food colorants. Applesauce D will not contain additional polyphenol-rich ingredients and is thus considered a low-polyphenol control.
Urinary Polyphenol Catabolite Concentration
Targeted analysis of free urinary polyphenol metabolites will be performed by ultra-high performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS).
Time frame: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
Urinary Anthocyanin Concentration
C18 solid-phase extraction (SPE) clean-up methods will be used to isolate anthocyanins and non-anthocyanin low-molecular weight polyphenol metabolites.
Time frame: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
Fecal Polyphenol Catabolite Concentration
C18 solid-phase extraction (SPE) clean-up methods will be used to isolate anthocyanins and non-anthocyanin low-molecular weight polyphenol metabolites.
Time frame: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
Fecal Anthocyanin Concentration
C18 solid-phase extraction (SPE) clean-up methods will be used to isolate anthocyanins and non-anthocyanin low-molecular weight polyphenol metabolites.
Time frame: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
Urine Creatinine Content
The urine creatinine content will be measured by a urinary creatinine colorimetric assay kit (Cayman Chemical).
Time frame: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
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University of Wisconsin, Madison