Last updated: September 9, 2022
Sponsor: Colorado State University
Overall Status: Completed
Phase
N/A
Condition
Atherosclerosis
Stress
Circulation Disorders
Treatment
N/AClinical Study ID
NCT03370991
1255927
Ages 45-65 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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-stimulatinghormone 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 3measurements, on 2 separate occasions - screening and baseline visits)
- Ability to provide informed consent
Exclusion
Exclusion Criteria:
- Systolic blood pressure < 120 or ≥ 139 mm Hg and/or diastolic blood pressure ≥ 90 mmHg
- Taking > 1 antihypertensive medication and/or taking the antihypertensive medicationfor < 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, orunwilling 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 forwomen, 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, orprocedures
Study Design
Total Participants: 43
Study Start date:
December 02, 2017
Estimated Completion Date:
September 30, 2021
Connect with a study center
Department of Food Science and Human Nutrition, Colorado State University
Fort Collins, Colorado 80523-1571
United StatesSite Not Available

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