Wild Blueberries for Gut, Brain, and Heart Health in Adults With High Blood Pressure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wild Blueberry, Placebo.
- Who it may be relevant to
- Registry conditions: Hypertension (Without Type 2 Diabetes Mellitus), High Blood Pressure, Male, Female. Basic parameters: 45 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Wild Blueberry Consumption on Gut, Brain, and Cardiovascular Health in Non-Hispanic Black and White Adults With High Blood Pressure
Overview
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 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.
Interventions
- Dietary supplement Wild Blueberry
Daily consumption of 22 g of freeze-dried wild blueberry freeze-dried powder for 8 weeks - Dietary supplement Placebo
Daily consumption of 22 g of freeze-dried macronutrient-matched placebo powder for 8 weeks
Primary outcome measures
- Ambulatory Blood Pressure [Time frame: Baseline, 4 weeks, and 8 weeks]
- Pulse Wave Velocity [Time frame: Baseline, 4 weeks, and 8 weeks]
Secondary outcome measures (11)
- Reactive Hyperemia Index [Time frame: Baseline, 4 weeks, and 8 weeks]
- Gut Microbiota Composition [Time frame: Baseline, 4 weeks, and 8 weeks]
- Global Cognitive Ability [Time frame: Screening]
- Performance Validity [Time frame: Baseline, 4 weeks, and 8 weeks]
- Verbal Memory & Recognition [Time frame: Baseline, 4 weeks, and 8 weeks]
- Cognitive Inhibition [Time frame: Baseline, 4 weeks, and 8 weeks]
- Working Memory [Time frame: Baseline, 4 weeks, and 8 weeks]
- Processing Speed [Time frame: Baseline, 4 weeks, and 8 weeks]
- Associative Memory [Time frame: Baseline, 4 weeks, and 8 weeks]
- Attention [Time frame: Baseline, 4 weeks, and 8 weeks]
- Problem-Solving [Time frame: Baseline, 4 weeks, and 8 weeks]
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 25-35 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Georgia State University — Atlanta
Publications
- 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 35458181
- 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 PMID 25578927
- 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. PMID 21106916
- 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, V PMID 35078371
Identifiers
NCT: NCT06735599 · H23563