Clinical trial NCT06735599: Wild Blueberries for Gut, Brain, and Heart Health in Adults With High Blood Pressure
Official title: Effects of Wild Blueberry Consumption on Gut, Brain, and Cardiovascular Health in Non-Hispanic Black and White Adults With High Blood Pressure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension (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
Keywords: Blueberries
Hypertension
Overweight
High Blood Pressure
Endothelial Function
Cognitive Function
Dietary intervention
functional foods
gut microbiota
arterial stiffness
microvascular function
Lead sponsor: Georgia State University
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: 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 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.

Eligibility criteria: 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 25-30 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 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

Primary outcomes:
measure: Ambulatory Blood Pressure
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Pulse Wave Velocity
timeFrame: Baseline, 4 weeks, and 8 weeks
Secondary outcomes:
measure: Reactive Hyperemia Index
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Gut Microbiota Composition
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Global Cognitive Ability
timeFrame: Screening
measure: Performance Validity
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Verbal Memory & Recognition
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Cognitive Inhibition
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Working Memory
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Processing Speed
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Associative Memory
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Attention
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Problem-Solving
timeFrame: Baseline, 4 weeks, and 8 weeks
Other outcomes:
measure: Percent Maximal Microvascular Blood Flow
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Circulating Markers of Inflammation and Oxidative Stress
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Urinary Polyphenolic Metabolites
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Body Fat
timeFrame: Baseline, 4 weeks, 8 weeks
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
Study officials:
affiliation: Georgia State University
name: Rafaela G Feresin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.