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Impact of Aronia Berry Consumption on Inflammation, Metabolites, and the Gut Microbiome

NCT05255718 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-03-13

No results posted yet for this study

Summary

The goal of this project is to elucidate interactions between the gut microbiome, anti-inflammatory/anti-oxidant food metabolomic signatures, and human inflammation phenotypes. Inflammation plays both direct and indirect roles in the development of type 2 diabetes (T2D), atherogenic cardiovascular diseases, and other causes of morbidity and mortality. Aronia melanocarpa (Aronia berries) are rich in bioactive polyphenolic compounds, which have been shown to lower inflammation and favorably impact metabolism. However, there is tremendous inter-individual variability in the bioavailability of polyphenolics and production of bioactive phenolic metabolites in the colon that depends, at least in part, on digestive metabolism by the gut microbiota. Little is known about the complex interactions among the gut microbiome, anti-inflammatory food metabolomic signatures, and human inflammation phenotypes. This study will utilize a systems-level approach to disentangle these complex interactions. The specific study objectives are as follows:

1. to determine the impact of Aronia supplementation on inflammation, metabolic health, and gut microbiome composition
2. to determine the static and dynamic metabolomic signature of Aronia based on an Aronia supplementation period and responses to a high-fat meal challenge

Conditions

Interventions

DIETARY_SUPPLEMENT

Aronia juice

Once daily dose of 100 mL of aronia juice

OTHER

Placebo

Once daily dose of 100 mL of placebo juice containing no polyphenols and matched to experimental Aronia juice in color, taste, and macronutrient content

Sponsors & Collaborators

  • Montana State University

    lead OTHER

Principal Investigators

  • Mary P Miles · Montana State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-27
Primary Completion
2019-08-18
Completion
2019-08-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05255718 on ClinicalTrials.gov