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Clinical Trials/NCT05488886
NCT05488886CompletedNot Applicable

Optimizing the Bioavailability and Metabolism of Aronia Berry Polyphenols for Improving Gut Health

University of Wisconsin, Madison1 site in 1 country13 target enrollmentStarted: February 9, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
13
Locations
1
Primary Endpoint
Urine Creatinine Content

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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

Arms & Interventions

A: Whole Aronia Berry Powder

Experimental

Intervention: Whole Aronia Berry Powder Applesauce (Dietary Supplement)

B: Aronia Berry Extract

Experimental

Intervention: Aronia Berry Extract Applesauce (Dietary Supplement)

C: Phospholipid-Polyphenol

Experimental

Intervention: Phospholipid-Polyphenol Applesauce (Dietary Supplement)

D: Low-Polyphenol Control

Experimental

Intervention: Low-Polyphenol Control Applesauce (Other)

Outcomes

Primary Outcomes

Urine Creatinine Content

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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