Wild Blueberries for Gut, Brain, and Heart Health in Adults With High Blood Pressure
NCT ID: NCT06735599
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-09-17
2026-01-01
Brief Summary
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Detailed Description
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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 8-week randomized, placebo-controlled parallel-arm 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Wild Blueberry
22 g of freeze-dried wild blueberry freeze-dried powder per day
Wild Blueberry
Daily consumption of 22 g of freeze-dried wild blueberry freeze-dried powder for 8 weeks
Placebo
22 g of freeze-dried macronutrient-matched placebo powder per day
Placebo
Daily consumption of 22 g of freeze-dried macronutrient-matched placebo powder for 8 weeks
Interventions
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Wild Blueberry
Daily consumption of 22 g of freeze-dried wild blueberry freeze-dried powder for 8 weeks
Placebo
Daily consumption of 22 g of freeze-dried macronutrient-matched placebo powder for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 25-30 kg/m2 via anthropometric measurements.
* Ability to give consent
Exclusion Criteria
* Use of one hypertensive drug for less than three months
* Use of more than one anti-hypertensive 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
45 Years
65 Years
ALL
No
Sponsors
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Georgia State University
OTHER
Responsible Party
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Rafaela G. Feresin
Associate Professor
Principal Investigators
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Rafaela G Feresin, PhD
Role: PRINCIPAL_INVESTIGATOR
Georgia State University
Locations
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Georgia State University
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Cassidy 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.
Tsao 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.
Other Identifiers
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H23563
Identifier Type: -
Identifier Source: org_study_id
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