CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 29 enrolled
Drug / intervention
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 +3 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04175106
NCT04175106N/ACompleted

Establishing Optimal Nutritional Quality of Blueberries: a Proof of Concept Study to Improve the Nutritional Quality of the Average Diet Using Common Plant Breeding and Processing Practices.

North Carolina State University·interventional·Posted Nov 22, 2019·Updated Feb 9, 2026

In Brief

A clinical study evaluating 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, a standard commercially available blueberry variety (i.e., cultivar), and 2 other interventions for Healthy. Completed, enrolled 29 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 22, 2019
Enrollment StartDec 13, 2019
Primary CompletionOct 29, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.6 years ago

Interventions

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 valueother

150 g of 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. Dietary restrictions will be observed (i.e. avoidance of food or supplements containing berry phytonutrients) for 7 days before each arm visit and throughout the study days.

a standard commercially available blueberry variety (i.e., cultivar)other

150 g of a standard commercially available blueberry variety (i.e., cultivar). Dietary restrictions will be observed (i.e. avoidance of food or supplements containing berry phytonutrients) for 7 days before each arm visit and throughout the study days.

a "minimally processed" blueberry-rich protein barother

A "minimally processed" blueberry-rich protein bar matched to the phytonutrient content of the 150 g of the non-traditional blueberry. Dietary restrictions will be observed (i.e. avoidance of food or supplements containing berry phytonutrients) for 7 days before each arm visit and throughout the study days.

a control beverage of matched-nutritive contentother

The matched nutritive content of the blueberry-rich protein bar will be dissolved in whey protein Dietary restrictions will be observed (i.e. avoidance of food or supplements containing berry phytonutrients) for 7 days before each arm visit and throughout the study days.