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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wild Blueberry | Experimental | 22 g of freeze-dried wild blueberry freeze-dried powder per day |
|
| Placebo | Placebo Comparator | 22 g of freeze-dried macronutrient-matched placebo powder per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wild Blueberry | Dietary Supplement | Daily consumption of 22 g of freeze-dried wild blueberry freeze-dried powder for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reactive Hyperemia Index | Assessment of endothelial function in response to increased shear stress using EndoPAT2000 | Baseline, 4 weeks, and 8 weeks |
| Gut Microbiota Composition | Analysis of stool sample for determination of absolute levels of bacteria and relative species composition |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Maximal Microvascular Blood Flow | Micro-vessel blood flow in response to local heating stimulus will be assessed using a Laser Doppler | Baseline, 4 weeks, and 8 weeks |
| Circulating Markers of Inflammation and Oxidative Stress |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rafaela G Feresin, PhD | Contact | 404-413-1233 | berries@gsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rafaela G Feresin, PhD | Georgia State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia State University | Recruiting | Atlanta | Georgia | 30303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35458181 | Background | 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. | |
| 25578927 | Background | 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. |
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| Placebo | Dietary Supplement | Daily consumption of 22 g of freeze-dried macronutrient-matched placebo powder for 8 weeks |
|
| Baseline, 4 weeks, and 8 weeks |
| Global Cognitive Ability | Measured using NIH Toolbox Picture Vocabulary and Oral Reading Recognition test | Screening |
| Performance Validity | Assessed using Rey 15 | Baseline, 4 weeks, and 8 weeks |
| Verbal Memory & Recognition | Measured using Rey Auditory Verbal Learning Test with appropriate alternate forms | Baseline, 4 weeks, and 8 weeks |
| Cognitive Inhibition | Assessed using Delis-Kaplan Executive Function System Trails and Verbal Fluency Switching | Baseline, 4 weeks, and 8 weeks |
| Working Memory | Measured using Digit Span and NIH Toolbox List Sorting | Baseline, 4 weeks, and 8 weeks |
| Processing Speed | Measured using NIH Toolbox Pattern Comparison and Oral Symbol Digit tests | Baseline, 4 weeks, and 8 weeks |
| Associative Memory | Measured using NIH Toolbox Face Name Associative Memory Exam and Face Name Associative Memory Exam Delay tests | Baseline, 4 weeks, and 8 weeks |
| Attention | Assessed using Wechsler Adult Intelligence Scale - IV and Rey Auditory Verbal Learning Test Trial 1. | Baseline, 4 weeks, and 8 weeks |
| Problem-Solving | Assessed using NIH Toolbox Visual Reasoning | 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.
| Baseline, 4 weeks, and 8 weeks |
| Urinary Polyphenolic Metabolites | 24-hour urine collection samples will be assessed for polyphenol metabolites | Baseline, 4 weeks, and 8 weeks |
| Body Fat | DEXA will be used to assess body fat mass | Baseline, 4 weeks, 8 weeks |
| 21106916 | Background | 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. |
| 35078371 | Background | 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. |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006940 | Hyperemia |
| D050177 | Overweight |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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