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Impacts of Aronia on Inflammation and the Gut Microbiome

NCT04128839 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-01-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Aronia berry juice

A juice blend of three different cultivars was used: Viking, MacKenzie and Autumn Magic. Raw juice was heat pasteurized before provided to participants. Participants consumed 100 mL of juice per day.

OTHER

Sham comparator

The placebo was flavor, color, and carbohydrate-matched to aronia juice. The placebo consisted of 28.8 g black cherry Koolaid mix (no sugar added), 128.5 g sorbitol, 74.5 g glucose, 77.9 g fructose, 4 oz lemon juice, 16 drops of blue food coloring, and enough water to create 1 L of solution. Participants consumed 100 mL of juice per day.

Sponsors & Collaborators

  • Montana State University

    lead OTHER

Principal Investigators

  • Mary P Miles, PhD · Montana State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-04-27
Primary Completion
2019-09-30
Completion
2021-12-27

Countries

  • United States

Study Locations

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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 NCT04128839 on ClinicalTrials.gov