NCT04128839

Impacts of Aronia on Inflammation and the Gut Microbiome

Completed NA Last updated 16 January 2024

What this trial tests

NA trial testing Aronia berry juice in Metabolic Syndrome in 40 participants. Completed in 27 December 2021.

Timeline

27 April 2019

Primary endpoint
30 September 2019

27 December 2021

Quick facts

Lead sponsor	Montana State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	40
Start date	27 April 2019
Primary completion	30 September 2019
Estimated completion	27 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Aronia berry juice
• Sham comparator

Conditions studied

• Metabolic Syndrome — all drugs for Metabolic Syndrome →
• Inflammation — all drugs for Inflammation →
• Hypertriglyceridemia — all drugs for Hypertriglyceridemia →
• Obesity — all drugs for Obesity →

Sponsor

Montana State University

Who can join

Adults 18 to 55, any sex, with Metabolic Syndrome or Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The overall goal of this project is to determine the inflammation lowering impact of anthocyanin-rich Aronia berries. Inflammation is an underlying mechanism driving the development of several diseases. While an elevation in immune signals in the systemic circulation is commonly attributed to adipose tissue, inflammation is not present in all obese individuals. Adipose tissue must become inflamed, and the inflammation trigger may come from other sources. Microorganisms (microbiome), host tissues, and immune cells residing in the gastrointestinal tract (GIT) are a key source of pro-inflammatory signals that may cause the host organism to become inflamed. Anthocyanins are bioactive compounds with established anti-inflammatory and microbiome altering properties. We hypothesize that the GIT microbiome is a key determinant of host inflammation than can be manipulated by anthocyanins-rich berries to lower inflammation. We assembled a cohort of individuals, characterized their GIT microbiome and performed anthropometric measurements, basal measures of metabolism and metabolic health, and triglyceridemic, metabolomic, and inflammation responses to a high-fat meal challenge.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Determinants of the postprandial triglyceride response to a high-fat meal in healthy overweight and obese adults.
   Wilson SM, Maes AP, Yeoman CJ, Walk ST, et al · · 2021 · cited 14× · PMID 34544430 · DOI 10.1186/s12944-021-01543-4
2. Metabolic impact of polyphenol-rich aronia fruit juice mediated by inflammation status of gut microbiome donors in humanized mouse model.
   Wilson SMG, Peach JT, Fausset H, Miller ZT, et al · · 2023 · cited 7× · PMID 37727634 · DOI 10.3389/fnut.2023.1244692
3. Temporal metabolic response yields a dynamic biosignature of inflammation.
   Peach JT, Wilson SM, Gunderson LD, Frothingham L, et al · · 2021 · cited 7× · PMID 34355150 · DOI 10.1016/j.isci.2021.102817
4. Determinants of the Postprandial Triglyceride Response to a High-fat Meal in Healthy Overweight and Obese Adults.
   Wilson SM, Maes AP, Yeoman CJ, Walk ST, et al · · 2021 · DOI 10.21203/rs.3.rs-617713/v1