Status:
COMPLETED
Blueberries for Improving Vascular Endothelial Function in Postmenopausal Women With Elevated Blood Pressure
Lead Sponsor:
Colorado State University
Collaborating Sponsors:
U.S. Highbush Blueberry Council
Conditions:
Menopause
Elevated Blood Pressure
Eligibility:
FEMALE
45-65 years
Phase:
NA
Brief Summary
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 end...
Eligibility Criteria
Inclusion
- Aged 45-65 years
- Postmenopausal women (≥ 1 years postmenopausal; natural or surgical menopause; confirmed by measurement of estradiol at a level \< 30 pg/mL and follicle-stimulating hormone at a level ≥ 30 mIU/mL)
- Elevated or stage 1-HTN (confirmed as resting seated systolic blood pressure \< 120 or ≥ 139 mmHg and/or a diastolic blood pressure ≥ 90 mmHg using an average of 3 measurements, on 2 separate occasions - screening and baseline visits)
- Ability to provide informed consent
Exclusion
- Systolic blood pressure \< 120 or ≥ 139 mm Hg and/or diastolic blood pressure ≥ 90 mmHg
- Taking \> 1 antihypertensive medication and/or taking the antihypertensive medication for \< 3 months
- Diagnosed cancer, cardiovascular disease, diabetes, or gastrointestinal, kidney, liver, and/or pancreatic disease
- Triglycerides \> 350 mg/dL, low-density lipoprotein cholesterol (LDL-C) ≥ 190 mg/dL, and/or taking a lipid-lowering medication
- Hormone replacement therapy use 6 months prior to study start
- Taking phosphodiesterase-5 inhibitors
- 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
- Active infection or antibiotic therapy
- Allergies or contraindication to study treatments, pharmacological agents, or procedures
Key Trial Info
Start Date :
December 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03370991
Start Date
December 2 2017
End Date
September 30 2021
Last Update
September 14 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Food Science and Human Nutrition, Colorado State University
Fort Collins, Colorado, United States, 80523-1571