Wild Blueberries for Gut, Brain, and Heart Health in Adults With High Blood Pressure
Effects of Wild Blueberry Consumption on Gut, Brain, and Cardiovascular Health in Non-Hispanic Black and White Adults With High Blood Pressure
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2024
CompletedFirst Submitted
Initial submission to the registry
November 5, 2024
CompletedFirst Posted
Study publicly available on registry
December 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
March 27, 2026
March 1, 2025
2.3 years
November 5, 2024
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Ambulatory Blood Pressure
Assessment of whole-day ambulatory blood pressure during daytime and nighttime periods.
Baseline, 4 weeks, and 8 weeks
Pulse Wave Velocity
Arterial Stiffness will be measured by pulse wave velocity using SphygmCor
Baseline, 4 weeks, and 8 weeks
Secondary Outcomes (11)
Reactive Hyperemia Index
Baseline, 4 weeks, and 8 weeks
Gut Microbiota Composition
Baseline, 4 weeks, and 8 weeks
Global Cognitive Ability
Screening
Performance Validity
Baseline, 4 weeks, and 8 weeks
Verbal Memory & Recognition
Baseline, 4 weeks, and 8 weeks
- +6 more secondary outcomes
Other Outcomes (4)
Percent Maximal Microvascular Blood Flow
Baseline, 4 weeks, and 8 weeks
Circulating Markers of Inflammation and Oxidative Stress
Baseline, 4 weeks, and 8 weeks
Urinary Polyphenolic Metabolites
Baseline, 4 weeks, and 8 weeks
- +1 more other outcomes
Study Arms (2)
Wild Blueberry
EXPERIMENTAL22 g of freeze-dried wild blueberry freeze-dried powder per day
Placebo
PLACEBO COMPARATOR22 g of freeze-dried macronutrient-matched placebo powder per day
Interventions
Daily consumption of 22 g of freeze-dried macronutrient-matched placebo powder for 8 weeks
Daily consumption of 22 g of freeze-dried wild blueberry freeze-dried powder for 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Georgia State University
Atlanta, Georgia, 30303, United States
Related Publications (4)
Krikorian R, Skelton MR, Summer SS, Shidler MD, Sullivan PG. Blueberry Supplementation in Midlife for Dementia Risk Reduction. Nutrients. 2022 Apr 13;14(8):1619. doi: 10.3390/nu14081619.
PMID: 35458181BACKGROUNDJohnson 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.
PMID: 25578927BACKGROUNDCassidy A, O'Reilly EJ, Kay C, Sampson L, Franz M, Forman JP, Curhan G, Rimm EB. Habitual intake of flavonoid subclasses and incident hypertension in adults. Am J Clin Nutr. 2011 Feb;93(2):338-47. doi: 10.3945/ajcn.110.006783. Epub 2010 Nov 24.
PMID: 21106916BACKGROUNDTsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.
PMID: 35078371BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rafaela G Feresin, PhD
Georgia State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 5, 2024
First Posted
December 16, 2024
Study Start
September 17, 2024
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
March 27, 2026
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share