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Evaluating the Availability of Berry Phytonutrients Post-consumption of Fresh and Processed Blueberry by Healthy Adults
NCT04175106 · View on ClinicalTrials.gov ↗
Study Summary
This study will evaluate the availability of phytonutrients in two blueberry varieties, chosen for their phytonutrient levels. This will be compared to phytonutrient-matched processed protein bar and a macronutrient-matched control meal, in healthy human volunteers. Blueberry phytonutrients will be analyzed in blood and urine over a four-day period, 48h prior to consumption and 48h after. The participants will consume each of the four meals over a 3-month period (4-way crossover design, 4 blocks of 4-day periods). The main objective of this study is to compare the proportions of blueberry phytonutrients recovered in the blood and urine after ingestion of the four treatments. We hypothesize that phytonutrient content will be predictive of human bioavailability and that a berry-enriched processed product will have similar phytonutrient bioavailability to unprocessed berries. The results of this study may establish if the nutritional value of a berry can be predicted or enhanced to provide elevated nutritional quality, with the ultimate goal of maximizing the health benefits of fruit consumption. As it is challenging for many to increase their fruit and vegetable intake to government recommended levels (5+ servings per day), the present proof-of-concept study explores a reasonable approach to help consumers achieve optimal health associated with high fruit and vegetable intakes, within the context of current consumption patterns, through enhancement of the nutritional density and bioavailability of common fruits and consumer products.
Conditions Studied
Interventions
- OTHER a non-traditional (i.e., not typically available in the supermarket) blueberry cultivar bred using natural plant breeding techniques and established as having enhanced nutritive value
- OTHER a standard commercially available blueberry variety (i.e., cultivar)
- OTHER a "minimally processed" blueberry-rich protein bar
- OTHER a control beverage of matched-nutritive content
Study Locations (1)
North Carolina
- Plants for Human Health Institute, North Carolina State University — Kannapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2019-12-13 |
| Est. Completion | 2021-10-29 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04175106
The ClinicalTrials.gov registry entry for NCT04175106 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is North Carolina State University, which has 13 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 4 interventions — of which a non-traditional (i.e., not typically available in the supermarket) blueberry cultivar bred using natural plant breeding techniques and established as having enhanced nutritive value is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04175106 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04175106 about?
NCT04175106 is a clinical study titled "Evaluating the Availability of Berry Phytonutrients Post-consumption of Fresh and Processed Blueberry by Healthy Adults". This study will evaluate the availability of phytonutrients in two blueberry varieties, chosen for their phytonutrient levels. This will be compared to phytonutrient-matched processed protein bar and a macronutrient-matched control meal, in healthy human volunteers. Blueberry phytonutrients will be ...
What is the current status of trial NCT04175106?
This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2019-12-13. Estimated completion is 2021-10-29.
What conditions does trial NCT04175106 study?
This clinical trial studies the following conditions: Healthy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04175106?
The interventions under investigation include: a non-traditional (i.e., not typically available in the supermarket) blueberry cultivar bred using natural plant breeding techniques and established as having enhanced nutritive value (OTHER), a standard commercially available blueberry variety (i.e., cultivar) (OTHER), a "minimally processed" blueberry-rich protein bar (OTHER), a control beverage of matched-nutritive content (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04175106?
This trial is sponsored by North Carolina State University, which has 13 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04175106 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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