Wild Blueberries for Gut, Brain, and Heart Health in Adults With High Blood Pressure

ConditionsHypertension (Without Type 2 Diabetes Mellitus)High Blood Pressure Male Female Adult Cognition Endothelial Function (Reactive Hyperemia)Oxidative Stress Diet Overweight Body Composition Measurement Gut Microbiome Arterial Stiffness Caucasian Whites Inflammation Microvascular Function

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age45-65

SponsorGeorgia State University

About this trial

The purpose of the study is to determine the effectiveness of wild blueberries on cardiovascular health, cognitive function, and gut microbiota composition in non-Hispanic Black and White adults with elevated blood pressure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals 45-65 years of age

Diagnosis of elevated blood pressure or stage 1 hypertension (systolic blood pressure = 120-139 mmHg and/or diastolic blood pressure = 80-89 mmHg) for at least 6 months

BMI 25-35 kg/m2 via anthropometric measurements.

Ability to give consent

Disqualifiers

Allergies to berries

Use of one hypertensive drug for less than three months

Use of more than one anti-hypertensive or statin drug, insulin, antibiotics, and anti-inflammatory drugs, active cancer, gastrointestinal, renal, cardiovascular, thyroid, and neurological disorders or severe head injury

Smoking

Trial design

Design model

Crossover

Treatments tested in this trial

Wild Blueberry
Dietary supplement
Daily consumption of 22 g of freeze-dried wild blueberry freeze-dried powder for 8 weeks
Placebo
Dietary supplement
Daily consumption of 22 g of freeze-dried macronutrient-matched placebo powder for 8 weeks

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Wild BlueberryExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Ambulatory Blood Pressure

Assessment of whole-day ambulatory blood pressure during daytime and nighttime periods.

Time frame

Baseline, 4 weeks, and 8 weeks

Pulse Wave Velocity

Arterial Stiffness will be measured by pulse wave velocity using SphygmCor

Time frame

Baseline, 4 weeks, and 8 weeks

Secondary outcomes

Reactive Hyperemia Index

Assessment of endothelial function in response to increased shear stress using EndoPAT2000

Time frame

Baseline, 4 weeks, and 8 weeks

Gut Microbiota Composition

Analysis of stool sample for determination of absolute levels of bacteria and relative species composition

Time frame

Baseline, 4 weeks, and 8 weeks

Global Cognitive Ability

Measured using NIH Toolbox Picture Vocabulary and Oral Reading Recognition test

Time frame

Screening

Performance Validity

Assessed using Rey 15

Time frame

Baseline, 4 weeks, and 8 weeks

Other outcomes

Percent Maximal Microvascular Blood Flow

Micro-vessel blood flow in response to local heating stimulus will be assessed using a Laser Doppler

Time frame

Baseline, 4 weeks, and 8 weeks

Circulating Markers of Inflammation and Oxidative Stress

Measurement of concentrations of circulating markers of inflammation such as CRP and oxidative stress such as TBARS in blood plasma and serum samples.

Time frame

Baseline, 4 weeks, and 8 weeks

Urinary Polyphenolic Metabolites

24-hour urine collection samples will be assessed for polyphenol metabolites

Time frame

Baseline, 4 weeks, and 8 weeks

Body Fat

DEXA will be used to assess body fat mass

Time frame

Baseline, 4 weeks, 8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Georgia State University

Lead sponsor

Source ClinicalTrials.gov

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