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Идёт набор NCT06735599

Wild Blueberries for Gut, Brain, and Heart Health in Adults With High Blood Pressure

Без фазы С лечением Hypertension (Without Type 2 Diabetes Mellitus) High Blood Pressure Male Female

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Wild Blueberry, Placebo.
Кому может быть актуально
Состояния в реестре: Hypertension (Without Type 2 Diabetes Mellitus), High Blood Pressure, Male, Female. Базовые параметры: 45 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of Wild Blueberry Consumption on Gut, Brain, and Cardiovascular Health in Non-Hispanic Black and White Adults With High Blood Pressure

Обзор

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.

Подробное описание

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.

Вмешательства

  • Пищевая добавка Wild Blueberry
    Daily consumption of 22 g of freeze-dried wild blueberry freeze-dried powder for 8 weeks
  • Пищевая добавка Placebo
    Daily consumption of 22 g of freeze-dried macronutrient-matched placebo powder for 8 weeks

Первичные конечные точки

  • Ambulatory Blood Pressure [Срок оценки: Baseline, 4 weeks, and 8 weeks]
  • Pulse Wave Velocity [Срок оценки: Baseline, 4 weeks, and 8 weeks]
Вторичные конечные точки (11)
  • Reactive Hyperemia Index [Срок оценки: Baseline, 4 weeks, and 8 weeks]
  • Gut Microbiota Composition [Срок оценки: Baseline, 4 weeks, and 8 weeks]
  • Global Cognitive Ability [Срок оценки: Screening]
  • Performance Validity [Срок оценки: Baseline, 4 weeks, and 8 weeks]
  • Verbal Memory & Recognition [Срок оценки: Baseline, 4 weeks, and 8 weeks]
  • Cognitive Inhibition [Срок оценки: Baseline, 4 weeks, and 8 weeks]
  • Working Memory [Срок оценки: Baseline, 4 weeks, and 8 weeks]
  • Processing Speed [Срок оценки: Baseline, 4 weeks, and 8 weeks]
  • Associative Memory [Срок оценки: Baseline, 4 weeks, and 8 weeks]
  • Attention [Срок оценки: Baseline, 4 weeks, and 8 weeks]
  • Problem-Solving [Срок оценки: Baseline, 4 weeks, and 8 weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Тройное слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Georgia State University — Atlanta

Публикации

  • 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

Идентификаторы

NCT: NCT06735599 · H23563

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗