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NCT05255718 · ClinicalTrials.gov registry record · NA
Impact of Aronia Berry Consumption on Inflammation, Metabolites, and the Gut Microbiome
A NA study, sponsored by Montana State University.
- Completed
- Registry status
- NA
- Development phase
- 13
- Enrollment target
NCT05255718: Completed NA study, sponsored by Montana State University.
NCT05255718 is a NA study that has completed, run by Montana State University. The registered enrollment target is 13 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05255718, a NA study, has completed, sponsored by Montana State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
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
Primary Outcome
Area under the curve for inflammatory cytokine (tumor necrosis factor-alpha, interleukin-(IL)1beta, IL-6, IL-10, IL-17, IL-23, interferon-gamma, and granulocyte macrophage-colony stimulating factor; all in pg/ml) concentrations after consuming a meal containing 50 g of fat
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Aronia juice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-04-27 |
| Est. Completion | 2019-08-18 |
| Phase | NA |
What the finished NCT05255718 record still lists
NCT05255718 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05255718 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05255718 about?
NCT05255718 is a clinical study titled "Impact of Aronia Berry Consumption on Inflammation, Metabolites, and the Gut Microbiome". 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 d...
What is the current status of trial NCT05255718?
This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2019-04-27. Estimated completion is 2019-08-18.
What interventions are being tested in trial NCT05255718?
The interventions under investigation include: Placebo (OTHER), Aronia juice (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05255718?
This trial is sponsored by Montana State University, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05255718's enrollment target sits among peer trials
13 1911th of 2000 higher than 88 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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