Evaluating the Availability of Berry Phytonutrients Post-consumption of Fresh and Processed Blueberry by Healthy Adults — BAM  

Healthy Clinical Trial

Official title: 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.

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

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.

After eligibility is confirmed, subjects will be randomly assigned to the four berry related interventions. The consumption of each intervention corresponds to one study period, which are separated by one-week washout. Blood will be collected at baseline and across 48h (1h, 3h, 6h, 9h, 24h, 48h) after intervention consumption while urine will be collected for 48h before and after intervention (-48h, -24h, 0-9h, 9-24h, 24-48h). ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT04175106
• Study type: Interventional
• Source: North Carolina State University
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 13, 2019
• Completion date: September 2022