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NCT04128839 · ClinicalTrials.gov registry record · NA
Impacts of Aronia on Inflammation and the Gut Microbiome
A NA study, sponsored by Montana State University.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT04128839 is a NA study that has completed, run by Montana State University. The registered enrollment target is 40 participants.
The verdict
NCT04128839, a NA study, has completed, sponsored by Montana State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
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.
Interventions
- OTHER Sham comparator
- DIETARY_SUPPLEMENT Aronia berry juice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-04-27 |
| Est. Completion | 2021-12-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04128839
The ClinicalTrials.gov registry entry for NCT04128839 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montana State University, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sham comparator is the first listed.
NCT04128839 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04128839 about?
NCT04128839 is a clinical study titled "Impacts of Aronia on Inflammation and the Gut Microbiome". 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 adipos...
What is the current status of trial NCT04128839?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2019-04-27. Estimated completion is 2021-12-27.
What interventions are being tested in trial NCT04128839?
The interventions under investigation include: Sham comparator (OTHER), Aronia berry juice (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04128839?
This trial is sponsored by Montana State University, which has 36 total clinical trials registered on ClinicalTrials.gov.
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