Wild Blueberries and Cardiovascular Health in Middle-aged/Older Men and Postmenopausal Women
Primary Purpose
Hypertension, Aging, Endothelial Dysfunction
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Blueberry Powder
Placebo Powder
Sponsored by
About this trial
This is an interventional basic science trial for Hypertension focused on measuring Cardiovascular Disease, Blueberries, Hypertension, Vascular Dysfunction, Atherosclerosis, Aging
Eligibility Criteria
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
Sites / Locations
- Food and Nutrition Clinical Research LaboratoryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Blueberry
Control
Arm Description
22 g blueberry powder per day
22 g placebo control powder per day
Outcomes
Primary Outcome Measures
Reactive hyperemia index
Endothelial function assessed as reactive hyperemia index using peripheral arterial tonometry (EndoPat)
Secondary Outcome Measures
Augmentation index
Arterial stiffness assessed as augmentation index using an automated blood pressure monitor (SphygmoCor)
Pulse wave velocity
Arterial stiffness assessed as carotid-femoral pulse wave velocity using an automated blood pressure monitor (SphygmoCor)
Endothelial cell protein expression
Protein expression will be assessed as an exploratory analysis for markers of nitric oxide bioavailability, inflammation, and/or oxidative stress will be measured by quantitative immunofluorescence in biopsied venous endothelial cells
Hemoglobin A1c
Blood hemoglobin A1C will be measured
Lipid profile
Blood lipid profiles will be measured
Nitric oxide metabolites
Blood nitrate/nitrite will be measured
ICAM-1
Blood ICAM-1 will be measured
VCAM-1
Blood VCAM-1 will be measured
Blood pressure
Brachial and Aortic blood pressure (systolic blood pressure, diastolic blood pressure, pulse pressure, aortic pressure) assessed using an automated blood pressure monitor (SphygmoCor)
Gut microbiota
Determine the effects on stool sample microbial populations
Plasma blueberry polyphenol metabolites
Targeted analysis of plasma metabolites by GC-MS and LC-MS
Full Information
NCT ID
NCT04530916
First Posted
January 27, 2020
Last Updated
August 21, 2023
Sponsor
Colorado State University
Collaborators
Wild Blueberry Association of North America
1. Study Identification
Unique Protocol Identification Number
NCT04530916
Brief Title
Wild Blueberries and Cardiovascular Health in Middle-aged/Older Men and Postmenopausal Women
Official Title
Antihypertensive and Vascular-Protective Effects of Wild Blueberries in Middle-Aged/Older Men and Postmenopausal Women.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colorado State University
Collaborators
Wild Blueberry Association of North America
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Aging, Endothelial Dysfunction, Men
Keywords
Cardiovascular Disease, Blueberries, Hypertension, Vascular Dysfunction, Atherosclerosis, Aging
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blueberry
Arm Type
Experimental
Arm Description
22 g blueberry powder per day
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
22 g placebo control powder per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Blueberry Powder
Intervention Description
22 g/day wild blueberry powder
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Powder
Intervention Description
22 g/day placebo powder
Primary Outcome Measure Information:
Title
Reactive hyperemia index
Description
Endothelial function assessed as reactive hyperemia index using peripheral arterial tonometry (EndoPat)
Time Frame
Baseline to 12 Weeks
Secondary Outcome Measure Information:
Title
Augmentation index
Description
Arterial stiffness assessed as augmentation index using an automated blood pressure monitor (SphygmoCor)
Time Frame
Baseline to 12 Weeks
Title
Pulse wave velocity
Description
Arterial stiffness assessed as carotid-femoral pulse wave velocity using an automated blood pressure monitor (SphygmoCor)
Time Frame
Baseline to 12 Weeks
Title
Endothelial cell protein expression
Description
Protein expression will be assessed as an exploratory analysis for markers of nitric oxide bioavailability, inflammation, and/or oxidative stress will be measured by quantitative immunofluorescence in biopsied venous endothelial cells
Time Frame
Baseline to 12 Weeks
Title
Hemoglobin A1c
Description
Blood hemoglobin A1C will be measured
Time Frame
Baseline to 12 Weeks
Title
Lipid profile
Description
Blood lipid profiles will be measured
Time Frame
Baseline to 12 Weeks
Title
Nitric oxide metabolites
Description
Blood nitrate/nitrite will be measured
Time Frame
Baseline to 12 Weeks
Title
ICAM-1
Description
Blood ICAM-1 will be measured
Time Frame
Baseline to 12 Weeks
Title
VCAM-1
Description
Blood VCAM-1 will be measured
Time Frame
Baseline to 12 Weeks
Title
Blood pressure
Description
Brachial and Aortic blood pressure (systolic blood pressure, diastolic blood pressure, pulse pressure, aortic pressure) assessed using an automated blood pressure monitor (SphygmoCor)
Time Frame
Baseline to 12 Weeks
Title
Gut microbiota
Description
Determine the effects on stool sample microbial populations
Time Frame
Baseline to 12 Weeks
Title
Plasma blueberry polyphenol metabolites
Description
Targeted analysis of plasma metabolites by GC-MS and LC-MS
Time Frame
Baseline to 12 Weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah A Johnson, PhD, RDN
Phone
970-491-3807
Email
sarah.johnson@colostate.edu
Facility Information:
Facility Name
Food and Nutrition Clinical Research Laboratory
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80523-1571
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah A Johnson, PhD, RDN
Phone
970-491-3807
Email
sarah.johnson@colostate.edu
First Name & Middle Initial & Last Name & Degree
Sarah A Johnson, PhD, RDN
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25578927
Citation
Johnson SA, Figueroa A, Navaei N, Wong A, Kalfon R, Ormsbee LT, Feresin RG, Elam ML, Hooshmand S, Payton ME, Arjmandi BH. Daily blueberry consumption improves blood pressure and arterial stiffness in postmenopausal women with pre- and stage 1-hypertension: a randomized, double-blind, placebo-controlled clinical trial. J Acad Nutr Diet. 2015 Mar;115(3):369-377. doi: 10.1016/j.jand.2014.11.001. Epub 2015 Jan 8.
Results Reference
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Wild Blueberries and Cardiovascular Health in Middle-aged/Older Men and Postmenopausal Women
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