Wild Blueberries and Cardiovascular Health in Middle-aged/Older Men and Postmenopausal Women (WB2020)

Colorado State University (CSU)

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Aging; Hypertension; Endothelial Dysfunction; Men

Treatments: Dietary Supplement: Placebo Powder; Dietary Supplement: Blueberry Powder

Study type: Interventional

Funder types: Other

Identifiers

NCT04530916

1775

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: Male

Ages: 45 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men and postmenopausal women
• Aged 45-70 years
• Elevated blood pressure or stage 1-Hypertension
• Ability to provide informed consent

Exclusion criteria

• Have had a menstrual cycle within the past year
• Blood Pressure < 120 (systolic BP) or ≥ 140/90 mm Hg
• Reactive hyperemia index > 3.00%
• Taking > 1 antihypertensive medication, taking 1 antihypertensive medication more than 1 time per day, and/or taking the antihypertensive medication for < 3 months
• Diagnosed cancer, cardiovascular disease, diabetes, or gastrointestinal, kidney, liver, lung, and/or pancreatic disease
• Triglycerides > 350 mg/dL, low-density lipoprotein cholesterol (LDL-C) ≥ 190 mg/dL, hemoglobin A1c ≥ 6.5%, and/or taking a lipid-lowering or glucose-lowering medication
• Testosterone or estrogen replacement therapy use 6 months prior to study start
• Weight change ≥ 3 kg in the past 3 months, actively trying to lose weight, or unwilling to remain weight stable throughout the study
• Current smokers or history of smoking in the past 12 months
• Binge and/or heavy drinker (>3 drinks on any given occasion and/or >7 drinks/week for women, and >4 drinks on any given occasion and/or >14 drinks/week for men)
• Body mass index < 18.5 or > 40 kg/m2
• Antibiotic therapy within past two months
• Allergies or contraindication to study treatments or procedures

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups, including a placebo group

Blueberry

Experimental group

Description:

22 g blueberry powder per day

Treatment:

Dietary Supplement: Blueberry Powder

Control

Placebo Comparator group

Description:

22 g placebo control powder per day

Treatment:

Dietary Supplement: Placebo Powder