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

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Information provided by:

Colorado State University

Last updated:

08/23/2022

Trial identifier:

NCT04530916

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Simplified Study Description Detailed Study Description

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.

Official Title

Glossary term:

Title

The official title of a protocol used to identify a clinical study or a short title written in language intended for the lay public.

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

Type of Study

Glossary term:

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access. Interventional studies (clinical trials): A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. Observational studies: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific intervention/treatment. A patient registry is a type of observational study. Expanded access: A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.

Interventional

Enrollment (Anticipated)

Glossary term:

Enrollment

The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.

Phase

Glossary term:

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0): Exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies). Phase 1: Clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants. Phase 2: Clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. Phase 3: Clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants. Phase 4: Clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use. Not Applicable: Trials without FDA-defined phases, including trials of devices or behavioral interventions.

Phase 1, Phase 2

Other Study ID Numbers

Glossary term:

Other study IDs

Identifiers or ID numbers other than the NCT number that are assigned to a clinicalstudy by the study's sponsor, funders, or others. These numbers may include unique identifiers from othertrial registries and National Institutes of Health grant numbers.

WB2020

Intervention / Treatment

Glossary term:

Intervention/treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Dietary Supplement: Blueberry Powder
Dietary Supplement: Placebo Powder

Study Start (Actual)

Glossary term:

Study start date

The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.

Jan 01, 2020

Primary Completion (Anticipated)

Glossary term:

Primary completion date

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.

Jun 01, 2023

Study Completion (Anticipated)

Glossary term:

Study completion date

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.

Dec 31, 2023

First Submitted Date

Glossary term:

First submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).

Jan 27, 2020

First Submitted that Met QC Criteria

Glossary term:

First submitted that met QC criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.

Aug 25, 2020

First Posted (Actual)

Glossary term:

First posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.

Aug 28, 2020

Last Update Submitted that Met MQ Criteria

Glossary term:

Last update submitted that met QC criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.

Aug 19, 2022

Last Update Posted (Actual)

Glossary term:

Last update posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date)and the last update posted date.

Aug 23, 2022

Other important Dates

Contacts and Locations

Locations (1)

Food and Nutrition Clinical Research Laboratory

Fort Collins, Colorado, United States, 80523-1571

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Contacts and Locations

Locations (1)

Food and Nutrition Clinical Research Laboratory

Fort Collins, Colorado 80523-1571

United States

Get Directions

Contacts

Study Contact

Glossary term:

Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Name: Sarah A Johnson, PhD, RDN

Phone Number: 970-491-3807

Email: sarah.johnson@colostate.edu

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. For general information about clinical research, read Guides to Clinical Trials.

Eligibility Criteria

Ages Eligible for Study:

Glossary term:

Age

A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups: The age groups are: Child (birth–17) Adult (18–64) Older adult (65+)

45 Years - 70 Years

Accepts Healthy Volunteers:

Glossary term:

Accepts Healthy Volunteers

A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.

Sexes Eligible for Study:

Glossary term:

Sex

A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.

Male

Description:

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

Study Plan

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

How is the study designed?

Design Details:

Primary Purpose:

Basic Science

Allocation:

Randomized

Interventional Model:

Parallel Assignment

Number of Arms:

Arms and Interventions:

Participant Group / Arm

Glossary term:

Arm

A group or subgroup of participants in a clinical trial that receives a specificintervention/treatment, or no intervention, according to the trial's protocol.

Intervention / Treatment

Glossary term:

Intervention/treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Experimental: Blueberry

22 g blueberry powder per day

Experimental: Blueberry

22 g blueberry powder per day

Dietary Supplement: Blueberry Powder

22 g/day wild blueberry powder

Dietary Supplement: Blueberry Powder

22 g/day wild blueberry powder

Placebo Comparator: Control

22 g placebo control powder per day

Placebo Comparator: Control

22 g placebo control powder per day

Dietary Supplement: Placebo Powder

22 g/day placebo powder

Dietary Supplement: Placebo Powder

22 g/day placebo powder

What is the study measuring?

Primary Outcome Measures

Glossary term:

Primary outcome measure

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.

Outcome Measure

Reactive hyperemia index

Measure Description

Endothelial function assessed as reactive hyperemia index using peripheral arterial tonometry (EndoPat)

Timeframe

Baseline to 12 Weeks

Outcome Measure

Measure Description

Timeframe

Reactive hyperemia index

Endothelial function assessed as reactive hyperemia index using peripheral arterial tonometry (EndoPat)

Baseline to 12 Weeks

Arterial stiffness assessed as augmentation index using an automated blood pressure monitor (SphygmoCor)

Baseline to 12 Weeks

Pulse wave velocity

Arterial stiffness assessed as carotid-femoral pulse wave velocity using an automated blood pressure monitor (SphygmoCor)

Baseline to 12 Weeks

Endothelial cell protein expression

Baseline to 12 Weeks

Hemoglobin A1c

Blood hemoglobin A1C will be measured

Baseline to 12 Weeks

Lipid profile

Blood lipid profiles will be measured

Baseline to 12 Weeks

Nitric oxide metabolites

Blood nitrate/nitrite will be measured

Baseline to 12 Weeks

ICAM-1

Blood ICAM-1 will be measured

Baseline to 12 Weeks

VCAM-1

Blood VCAM-1 will be measured

Baseline to 12 Weeks

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)

Baseline to 12 Weeks

Gut microbiota

Determine the effects on stool sample microbial populations

Baseline to 12 Weeks

Plasma blueberry polyphenol metabolites

Targeted analysis of plasma metabolites by GC-MS and LC-MS

Baseline to 12 Weeks

Sponsor and Collaborators

The Sponsor of a study is the organization or person that is conducting the study. They may provide resources needed to do the investigation.

Sponsor:

Glossary term:

Sponsor

The organization or person who initiates the study and who has authority and control over the study.

Colorado State University

Investigators and Collaborators

Investigators:

Glossary term:

Investigator

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.

Central Contacts:

Sarah A Johnson, PhD, RDN

Overall Officials:

Collaborators:

Glossary term:

Collaborator

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.

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Official Title Glossary term: Title The official title of a protocol used to identify a clinical study or a short title written in language intended for the lay public.

Enrollment (Anticipated) Glossary term: Enrollment The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.

Study Start (Actual) Glossary term: Study start date The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.

Food and Nutrition Clinical Research Laboratory

Study Contact Glossary term: Contact The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Ages Eligible for Study: Glossary term: Age A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups: The age groups are: Child (birth–17) Adult (18–64) Older adult (65+)

Accepts Healthy Volunteers: Glossary term: Accepts Healthy Volunteers A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.

Description:

Design Details:

Primary Purpose:

Allocation:

Interventional Model:

Number of Arms:

Arms and Interventions:

Participant Group / Arm Glossary term: Arm A group or subgroup of participants in a clinical trial that receives a specificintervention/treatment, or no intervention, according to the trial's protocol.

Outcome Measure

Measure Description

Timeframe

Outcome Measure

Measure Description

Timeframe

Outcome Measure

Measure Description

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Outcome Measure

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Outcome Measure

Measure Description

Timeframe

Outcome Measure

Measure Description

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Outcome Measure

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Outcome Measure

Measure Description

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Outcome Measure

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Outcome Measure

Measure Description

Timeframe

Outcome Measure

Measure Description

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Outcome Measure

Measure Description

Timeframe

Outcome Measure

Measure Description

Timeframe

Outcome Measure

Measure Description

Timeframe

Sponsor: Glossary term: Sponsor The organization or person who initiates the study and who has authority and control over the study.

Investigators and Collaborators

Investigators and Collaborators

Investigators: Glossary term: Investigator A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.

Central Contacts:

Overall Officials:

Collaborators: Glossary term: Collaborator An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.

Publications

Publications of Study Results

General Publications

Publications Automatically Indexed to this Study by ClinicalTrials.Gov Identifier (NCT Number

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Description goes here about the trial taking up at most two lines of copy.

Official Title

Glossary term:

Title

The official title of a protocol used to identify a clinical study or a short title written in language intended for the lay public.

Enrollment (Anticipated)

Glossary term:

Enrollment

The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.

Study Start (Actual)

Glossary term:

Study start date

The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.

Study Contact

Glossary term:

Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Ages Eligible for Study:

Glossary term:

Age

A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups: The age groups are: Child (birth–17) Adult (18–64) Older adult (65+)

Accepts Healthy Volunteers:

Glossary term:

Accepts Healthy Volunteers

A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.

Participant Group / Arm

Glossary term:

Arm

A group or subgroup of participants in a clinical trial that receives a specificintervention/treatment, or no intervention, according to the trial's protocol.

Sponsor:

Glossary term:

Sponsor

The organization or person who initiates the study and who has authority and control over the study.

Investigators:

Glossary term:

Investigator

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.

Collaborators:

Glossary term:

Collaborator

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.