Bioavailability of Aronia Berry Polyphenols

NCT05488886 | Completed

• 3 other identifiers: 2022-0702Protocol Version 07/01/2022A074000
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Health; Metabolism; Polyphenols

Outcome Measures

Primary Outcomes (5)

• 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).

  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.

  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.

  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.

  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).

  sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)

Study Arms (4)

A: Whole Aronia Berry Powder

EXPERIMENTAL

Dietary Supplement: Whole Aronia Berry Powder Applesauce

B: Aronia Berry Extract

EXPERIMENTAL

Dietary Supplement: Aronia Berry Extract Applesauce

C: Phospholipid-Polyphenol

EXPERIMENTAL

Dietary Supplement: Phospholipid-Polyphenol Applesauce

D: Low-Polyphenol Control

EXPERIMENTAL

Other: Low-Polyphenol Control Applesauce

Interventions

Whole Aronia Berry Powder Applesauce DIETARY_SUPPLEMENT

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).

A: Whole Aronia Berry Powder

Aronia Berry Extract Applesauce DIETARY_SUPPLEMENT

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).

B: Aronia Berry Extract

Phospholipid-Polyphenol Applesauce DIETARY_SUPPLEMENT

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).

C: Phospholipid-Polyphenol

Low-Polyphenol Control Applesauce OTHER

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.

D: Low-Polyphenol Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

Study Officials

• Bradley Bolling, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The order of intervention foods (A-D) will be randomized for each participant upon study enrollment. Wash-in and wash-out periods are 6 days long, and food consumption and sampling durations are 24 hours.

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 5, 2022
• Study Start: February 9, 2023
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)