RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Antihypertensive and Vascular-Protective Effects of Wild Blueberries in Middle-Aged/Older Men and Postmenopausal Women.

Quick Facts

Study Start:2020-01-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04530916

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 70 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and postmenopausal women
  2. * Aged 45-70 years
  3. * Elevated blood pressure or stage 1-Hypertension
  4. * Ability to provide informed consent
  1. * Have had a menstrual cycle within the past year
  2. * Blood Pressure \< 120 (systolic BP) or ≥ 140/90 mm Hg
  3. * Reactive hyperemia index \> 3.00%
  4. * Taking \> 1 antihypertensive medication, taking 1 antihypertensive medication more than 1 time per day, and/or taking the antihypertensive medication for \< 3 months
  5. * Diagnosed cancer, cardiovascular disease, diabetes, or gastrointestinal, kidney, liver, lung, and/or pancreatic disease
  6. * 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
  7. * Testosterone or estrogen replacement therapy use 6 months prior to study start
  8. * Weight change ≥ 3 kg in the past 3 months, actively trying to lose weight, or unwilling to remain weight stable throughout the study
  9. * Current smokers or history of smoking in the past 12 months
  10. * 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)
  11. * Body mass index \< 18.5 or \> 40 kg/m2
  12. * Antibiotic therapy within past two months
  13. * Allergies or contraindication to study treatments or procedures

Contacts and Locations

Study Contact

Sarah A Johnson, PhD, RDN
CONTACT
970-491-3807
sarah.johnson@colostate.edu

Study Locations (Sites)

Food and Nutrition Clinical Research Laboratory
Fort Collins, Colorado, 80523-1571
United States

Collaborators and Investigators

Sponsor: Colorado State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2020-01-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Cardiovascular Disease
  • Blueberries
  • Hypertension
  • Vascular Dysfunction
  • Atherosclerosis
  • Aging

Additional Relevant MeSH Terms

  • Hypertension
  • Aging
  • Endothelial Dysfunction
  • Men