NCT03370991

Blueberries for Improving Vascular Endothelial Function in Postmenopausal Women With Elevated Blood Pressure

Completed NA Last updated 14 September 2022

What this trial tests

NA trial testing Blueberry Powder in Menopause in 43 participants. Completed in 30 September 2021.

Timeline

2 December 2017

Primary endpoint
30 September 2021

30 September 2021

Quick facts

Lead sponsor	Colorado State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	43
Start date	2 December 2017
Primary completion	30 September 2021
Estimated completion	30 September 2021
Sites	1 location across United States

Drugs / interventions tested

• Blueberry Powder
• Placebo Powder

Conditions studied

• Menopause — all drugs for Menopause →
• Elevated Blood Pressure — all drugs for Elevated Blood Pressure →
• Hypertension — all drugs for Hypertension →
• Endothelial Dysfunction — all drugs for Endothelial Dysfunction →

Sponsor

Colorado State University

Who can join

Adults 45 to 65, female only, with Menopause or Elevated Blood Pressure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Postmenopausal women are at an increased risk of developing cardiovascular disease (CVD) largely due to accelerated aging-related modifications to vascular health following menopause. The vascular endothelium is responsible for producing chemicals that are essential for proper vasodilation and blood flow and therefore is involved in maintaining normal blood pressure. A major modification that occurs during aging and is accelerated during menopause is termed vascular endothelial dysfunction which is characterized by impaired endothelium-dependent dilation. This can lead to increased blood pressure, atherosclerosis, and increased risk of CVD and death. Nitric oxide (NO) is a chemical produced by the endothelium and is essential for normal endothelial function and cardiovascular health. Vascular endothelial dysfunction is primarily caused by reduced NO bioavailability secondary to excessive oxidative stress. Approximately 3/4 of postmenopausal women have elevated blood pressure or hypertension which further worsens endothelial function and increases CVD risk through increased oxidative stress and inflammation. Blueberries are rich in phytochemicals including anthocyanins, phenolic acids, and pterostilbene. These phytochemicals and their metabolites are known to attenuate oxidative stress and inflammation. The overall goal of the current study is to assess the efficacy of blueberries to improve vascular endothelial dysfunction in this high-risk population and to gain insight into underlying mechanisms. 58 postmenopausal women with elevated blood pressure and stage 1-HTN will be asked to consume 22 grams freeze-dried blueberry powder or placebo powder per day for 12 weeks. Vascular endothelial function will be assessed at baseline and 12 weeks. Measurements indicative of vascular nitric oxide production, oxidative stress, inflammation, cardiometabolic health, cognitive function, and blueberry phytochemical metabolism will be measured at baseline and 12 weeks. Blood pressure will be assessed at baseline and 4, 8, and 12 weeks.

Publications & conference data

5 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. Daily blueberry consumption for 12 weeks improves endothelial function in postmenopausal women with above-normal blood pressure through reductions in oxidative stress: a randomized controlled trial.
   Woolf EK, Terwoord JD, Litwin NS, Vazquez AR, et al · · 2023 · cited 31× · PMID 36847333 · DOI 10.1039/d3fo00157a
3. Harnessing Nature's Toolbox: Naturally Derived Bioactive Compounds in Nanotechnology Enhanced Formulations.
   Sanjai C, Gaonkar SL, Hakkimane SS. · · 2024 · cited 10× · PMID 39494011 · DOI 10.1021/acsomega.4c07756
4. 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
5. 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