Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05488886 |
| Other study ID # |
2022-0702 |
| Secondary ID |
Protocol Version |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 9, 2023 |
| Est. completion date |
March 28, 2023 |
Study information
| Verified date |
March 2023 |
| Source |
University of Wisconsin, Madison |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
