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N/A Completed N=44 Randomized Triple-blind Prevention

The Blueberry Study

Healthy
Source: ClinicalTrials.gov NCT04421950 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Phenolic Acid Metabolites Measured in Plasma and Urine After Dietary Intervention — 13; 0; 25; 3 Counts of metabolites

Summary

This is a research study about the effects of blueberries on the health of children who do not eat much fruits and vegetables. By doing this study, we hope to find out what nutrients from blueberries appear in the blood and urine of the child

Outcome Measures

OutcomeResultp-value
PRIMARY
Phenolic Acid Metabolites Measured in Plasma and Urine After Dietary Intervention
13; 0; 25; 3
SECONDARY
Number and Percentage of Lymphocytes Cluster of Differentiation 4 (CD4), Lymphocytes Cluster of Differentiation 8 (CD8) and Natural Killer (NK) Cells
SECONDARY
T-lymphocyte Responsiveness to Immune Stressors
SECONDARY
Endothelial Function by Brachial Artery Flow Mediated Dilation
9.4; 9.4 <0.05 sig

Eligibility Criteria

Inclusion Criteria

  • Eats <1.5 cup of fruit and <2.0 cup of vegetables per day
  • Boys or girls
  • All ethnicities
  • All BMIs

Exclusion Criteria

  • Known allergy to blueberries
  • Epilepsy
  • Asthma
  • Chronic kidney disease
  • Hormonal disease
  • Autoimmune disease
  • Bleeding disorders
  • Chronic infections
  • Type 2 and Type 1 diabetes mellitus
  • Attention deficit hyperactivity disorder
  • Opposition defiant disorder
  • Autistic spectrum disorder
  • Pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest
  • If the participants/parents perceive barriers with adhering to low-polyphenol meals
  • Parent or child refusal to stop nutritional supplements
  • Parent or child refusal to have blood drawn
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04421950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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