NCT04530916: WB2020

Wild Blueberries and Cardiovascular Health in Middle-aged/Older Men and Postmenopausal Women

Active, enrolled Phase 1, PHASE2 Last updated 17 November 2025

What this trial tests

Phase 1, PHASE2 trial testing Blueberry Powder in Hypertension in 58 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 January 2020

Primary endpoint
31 March 2025

31 December 2025

Quick facts

Lead sponsor	Colorado State University
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	basic science
Enrollment	58
Start date	1 January 2020
Primary completion	31 March 2025
Estimated completion	31 December 2025
Sites	1 location across United States

Drugs / interventions tested

• Blueberry Powder
• Placebo Powder

Conditions studied

• Hypertension — all drugs for Hypertension →
• Aging — all drugs for Aging →
• Endothelial Dysfunction — all drugs for Endothelial Dysfunction →
• Men — all drugs for Men →

Sponsor

Colorado State University

Who can join

Adults 45 to 70, male only, with Hypertension or Aging. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality worldwide. Aging is the primary risk factor for CVD, in large part due to adverse modifications to the arteries. These modifications include vascular endothelial dysfunction and arterial stiffness. Vascular endothelial dysfunction is an initiating step in atherosclerosis, and is primarily caused by reduced nitric oxide (NO) bioavailability secondary to excessive superoxide-driven oxidative stress and inflammation. Endothelial dysfunction leads to arterial stiffness and the development of hypertension (HTN) which further increases CVD. Greater than 2/3 of the US population has elevated blood pressure or stage 1-HTN. As such, interventions that improve vascular endothelial dysfunction by increasing NO bioavailability and mitigating excessive oxidative stress and inflammation are needed. Blueberries are rich in bioactive compounds including flavonoids, phenolic acids, and pterostilbene. These compounds and their metabolites have been shown to attenuate oxidative stress and inflammation. The primary goal of this study is to assess the efficacy of blueberries to improve reduce blood pressure and improve vascular endothelial dysfunction and arterial stiffness in middle-aged/older men with elevated blood pressure or stage 1-HTN.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. New Insights into Dietary Pterostilbene: Sources, Metabolism, and Health Promotion Effects.
   Nagarajan S, Mohandas S, Ganesan K, Xu B, et al · · 2022 · cited 57× · PMID 36234852 · DOI 10.3390/molecules27196316
2. Stilbenes: a promising small molecule modulator for epigenetic regulation in human diseases.
   Tian J, Jin L, Liu H, Hua Z. · · 2023 · cited 12× · PMID 38155902 · DOI 10.3389/fphar.2023.1326682
3. Body Composition and Senescence: Impact of Polyphenols on Aging-Associated Events.
   Santos TWD, Pereira QC, Fortunato IM, Oliveira FS, et al · · 2024 · cited 4× · PMID 39519454 · DOI 10.3390/nu16213621
4. Cardiovascular ageing: hallmarks, signaling pathways, diseases and therapeutic targets.
   Zheng P, Yan W, Ding Y, Zhang Y, et al · · 2026 · PMID 42010239 · DOI 10.1038/s41392-026-02630-7