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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 for Healthy Subjects (BAM Trial)

N/A
Waitlist Available
Led By Colin D Kay, PhD
Research Sponsored by North Carolina State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 days collection per intervention; 1 baseline collection, followed by 1,3,6,9,24 and 48 hours post-treatment collections or blood, and -48,-24,0-9, 9-24 and 24-48 hours collections for urine.
Awards & highlights

BAM Trial Summary

This trial will compare the availability of phytonutrients in two blueberry varieties, chosen for their high phytonutrient levels. This will be compared to a phytonutrient-matched processed protein bar and a macronutrient-matched control meal, in healthy human volunteers.

BAM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 days collection per intervention; 1 baseline collection, followed by 1,3,6,9,24 and 48 hours post-treatment collections or blood, and -48,-24,0-9, 9-24 and 24-48 hours collections for urine.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 days collection per intervention; 1 baseline collection, followed by 1,3,6,9,24 and 48 hours post-treatment collections or blood, and -48,-24,0-9, 9-24 and 24-48 hours collections for urine. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bioavailability of (poly)phenols and microbial metabolites in the blood and urine between the treatments, using broad spectrum metabolomic analysis
Secondary outcome measures
Characterization of maximum serum concentration [Cmax] of (poly)phenols and microbial metabolites in the blood and urine between the treatments, using broad spectrum metabolomic analysis
Other outcome measures
Characterization of the area under the curve [AUC] of (poly)phenols and microbial metabolites in the blood and urine between the treatments, using broad spectrum metabolomic analysis
Characterization of the area under the first moment curve [AUMC] of (poly)phenols and microbial metabolites in the blood and urine between the treatments, using broad spectrum metabolomic analysis
Characterization of the half-life [t1/2] of (poly)phenols and microbial metabolites in the blood and urine between the treatments, using broad spectrum metabolomic analysis
+4 more

BAM Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: a phytochemical-rich blueberry varietyExperimental Treatment1 Intervention
Single-time consumption of 150 g phytochemical-rich blueberry per participant.
Group II: a phytochemical-poor blueberry varietyExperimental Treatment1 Intervention
Single-time consumption of 150 g phytochemical-poor blueberry per participant.
Group III: a "minimally processed" blueberry-rich protein barExperimental Treatment1 Intervention
Single-time consumption of blueberry-rich protein bar matched for 150 g blueberry phytochemicals.
Group IV: a blueberry control beverage of matched-nutritive contentPlacebo Group1 Intervention
Single-time consumption of control beverage matched for the macronutrient content of the blueberry-rich protein bar.

Find a Location

Who is running the clinical trial?

North Carolina State UniversityLead Sponsor
33 Previous Clinical Trials
15,532 Total Patients Enrolled
Foundation for Food and Agriculture ResearchUNKNOWN
Colin D Kay, PhDPrincipal InvestigatorNorth Carolina State University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Evaluating the Availability of Berry Phytonutrients Post-consumption of Fresh and Processed Blueberry by Healthy Adults
Colin D. Kay 2019. "Evaluating the Availability of Berry Phytonutrients Post-consumption of Fresh and Processed Blueberry by Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04175106.
~5 spots leftby Apr 2025
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