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NCT Number: NCT06735599

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

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.

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia State University

Atlanta, Georgia, 30303, United States

Location status: Recruiting

Location contact

Andrew Gerwitz, PhD

SUB_INVESTIGATOR

Brett J Wong, PhD

SUB_INVESTIGATOR

Elizabeth L Tighe, PhD

SUB_INVESTIGATOR

Rafaela Feresin, PhD

CONTACT

[email protected]

404-413-1233

Rafaela G Feresin, PhD

PRINCIPAL_INVESTIGATOR

Tricia Z King, PhD

SUB_INVESTIGATOR

About this study

Hypertension (HTN), or high blood pressure (BP) is a major modifiable risk factor for heart disease, the leading cause of death worldwide. In the U.S., 121.5 million adults have high BP and only 25% have their BP under control. The 2022 Heart Disease and Stroke Statistics indicated that the incidence of high BP was higher among non-Hispanic Black (NHB) compared to non-Hispanic White (NHW) adults. Berries are rich in fiber and phytochemicals and have several health benefits. A 14-year follow-up of the Nurses' Health Study I and II and the Health Professional Follow-Up Study revealed a significant reduction in the risk of HTN (8%) among individuals in the highest quintile of anthocyanin intake compared to the lowest quintile. Blueberries are rich in fiber and phytochemicals that may be responsible for their health benefits. Studies have shown that daily blueberry consumption improves heart, cognitive, and intestinal health in different populations. Yet, a comprehensive study exploring and comparing the effectiveness of wild blueberries for cardiovascular, intestinal, and cognitive function parameters and their association in NHB and NHW adults with high BP has not been conducted to date.

Thus, the overall objective of this timely study is to determine and compare the effectiveness of a freeze-dried wild blueberry intervention on cardiovascular and gut health in NHB and NHW adults with high BP and assess whether these health benefits are associated with improvements in memory and other important thinking abilities for productivity and quality of life.

Therefore, this 6 - month randomized, placebo-controlled crossover clinical trial aims to assess whether daily consumption of 22 g of freeze-dried wild blueberry powder improves gut, cardiovascular, and cognitive function in NHB and NHW adults with elevated blood pressure and stage 1 hypertension. Investigators hypothesize that daily consumption of wild blueberries will improve cardiovascular parameters, gut dysbiosis, and cognitive function. To test these hypotheses, the following specific aims are proposed. To investigate whether daily consumption of 22 g of freeze-dried wild blueberry powder:

  • Reduces BP, improves endothelial function, arterial stiffness, and microcirculation.
  • Favorably modulates gut microbiota composition.
  • Improves cognitive function (verbal memory and executive functions [inhibition, working memory, cognitive flexibility]).
  • Improves serum markers of oxidative stress and inflammation.

Additionally, investigators will also explore whether changes in the gut microbiota are associated with changes in cardiometabolic and cognitive function outcomes and whether changes in cardiometabolic outcomes are associated with changes in cognitive function parameters globally and within each race.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Alcohol consumption (>2 drinks/day)
  • Consuming antioxidant, probiotic, and prebiotic supplements
  • Pregnant or lactating
  • Participating in a weight loss program

Treatment and study plan

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

Primary outcomes

  1. Ambulatory Blood Pressure

    Time frame: Baseline, 4 weeks, and 8 weeks

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

  2. Pulse Wave Velocity

    Time frame: Baseline, 4 weeks, and 8 weeks

    Arterial Stiffness will be measured by pulse wave velocity using SphygmCor

Secondary outcomes

  1. Reactive Hyperemia Index

    Time frame: Baseline, 4 weeks, and 8 weeks

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

  2. Gut Microbiota Composition

    Time frame: Baseline, 4 weeks, and 8 weeks

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

  3. Global Cognitive Ability

    Time frame: Screening

    Measured using NIH Toolbox Picture Vocabulary and Oral Reading Recognition test

  4. Performance Validity

    Time frame: Baseline, 4 weeks, and 8 weeks

    Assessed using Rey 15

  5. Verbal Memory & Recognition

    Time frame: Baseline, 4 weeks, and 8 weeks

    Measured using Rey Auditory Verbal Learning Test with appropriate alternate forms

  6. Cognitive Inhibition

    Time frame: Baseline, 4 weeks, and 8 weeks

    Assessed using Delis-Kaplan Executive Function System Trails and Verbal Fluency Switching

  7. Working Memory

    Time frame: Baseline, 4 weeks, and 8 weeks

    Measured using Digit Span and NIH Toolbox List Sorting

  8. Processing Speed

    Time frame: Baseline, 4 weeks, and 8 weeks

    Measured using NIH Toolbox Pattern Comparison and Oral Symbol Digit tests

  9. Associative Memory

    Time frame: Baseline, 4 weeks, and 8 weeks

    Measured using NIH Toolbox Face Name Associative Memory Exam and Face Name Associative Memory Exam Delay tests

  10. Attention

    Time frame: Baseline, 4 weeks, and 8 weeks

    Assessed using Wechsler Adult Intelligence Scale - IV and Rey Auditory Verbal Learning Test Trial 1.

  11. Problem-Solving

    Time frame: Baseline, 4 weeks, and 8 weeks

    Assessed using NIH Toolbox Visual Reasoning

Other outcomes

  1. Percent Maximal Microvascular Blood Flow

    Time frame: Baseline, 4 weeks, and 8 weeks

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

  2. Circulating Markers of Inflammation and Oxidative Stress

    Time frame: Baseline, 4 weeks, and 8 weeks

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

  3. Urinary Polyphenolic Metabolites

    Time frame: Baseline, 4 weeks, and 8 weeks

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

  4. Body Fat

    Time frame: Baseline, 4 weeks, 8 weeks

    DEXA will be used to assess body fat mass

Study contacts

Contact information is provided by the study sponsor or research team.

Rafaela G Feresin, PhD

CONTACT

[email protected]

404-413-1233

Sponsors and collaborators

Lead sponsor

Georgia State University

Other

Registry information

Official study title

Effects of Wild Blueberry Consumption on Gut, Brain, and Cardiovascular Health in Non-Hispanic Black and White Adults With High Blood Pressure

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 16, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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