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Идёт набор NCT06062017

Potassium, Hydration, Cardiovascular, and Kidney Study (PHACKs)

Без фазы С лечением Blood Pressure Hydration Vascular Disease Risk

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: Water and Potassium supplementation.
Кому может быть актуально
Состояния в реестре: Blood Pressure, Hydration, Vascular Disease Risk. Базовые параметры: 18 лет — 30 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

The Effects of Water and Potassium Supplementation on Cardiovascular and Kidney Function in Young Adults

Обзор

Compared with White Adults, Non-Hispanic Black Adults are at an elevated risk of developing cardiovascular disease (CVD) and end stage chronic-kidney disease (CKD), two of the leading causes of death in the United States. Inadequate hydration status is associated with risk factors for both CVD and CKD. Prior data show that Black individuals are less likely to be adequately hydrated when compared with their White counterparts. Further, socioeconomic factors have been shown to influence hydration practices. Inadequate hydration influences certain hormones that regulate blood volume and impact blood pressure, but increasing potassium intake may provide some positive effects on normalizing these hormones and blood pressure. Black adults, in particular, are more likely to consume less potassium, have inadequate hydration, and tend to have higher blood pressure. As such, there is a critical need for effective strategies to address racial disparities in hydration and resultant health consequences; as well as establish the role of socioeconomic factors contributing to hydration. Therefore, the investigators are seeking to test the investigators' central hypothesis that water with a potassium supplement will improve hydration and cardiovascular health in young White adults (n = 20, 10 females, 10 males), and to a greater extent in young Black Adults (n = 20, 10 females, 10 males. The investigators will assess measures of blood pressure, arterial stiffness, and biomarkers in the urine and blood samples prior to and following a 14-day hydration intervention of 1) bottled water and 2) bottled water with potassium supplementation (2000mg potassium/day).

Подробное описание

Compared with White adults, Non-Hispanic Black adults are at an elevated risk of developing cardiovascular disease (CVD) and end-stage chronic kidney disease (CKD) two of the leading causes of mortality in the United States (U.S.). Inadequate hydration status is associated with all-cause mortality and several risk factors for CVD and CKD including obesity, insulin resistance, hypertension, and metabolic syndrome. Prior data demonstrate Black American individuals are more likely to be hypohydrated (i.e., inadequately hydrated) when compared with White individuals. One study in emerging adults (18-25 years old) indicates that Black adults are more likely to be hypohydrated compared with White adults when assessed using gold-standard 24-hour urine collections. Socioeconomic factors influence hydration practices. For example, there are well-justified increased perceptions of unsafe tap water among racial and ethnic minorities. Indeed, the recent Flint, Michigan, and Jackson, Mississippi water crises have raised public awareness over these environmental injustices and ways to increase safe drinking water availability and access. However, there remains a critical need for empirical studies on 1) strategies to address racial disparities in hydration and resultant health consequences; and 2) the role socioeconomic factors in contributing to hydration.

Importantly, hypohydration is associated with increased production of arginine vasopressin (AVP), a peptide hormone produced in the hypothalamus that influences body water balance via anti-diuretic effects. Plasma copeptin is an established surrogate marker of circulating AVP concentration. Plasma copeptin is associated with incident type 2 diabetes, metabolic syndrome, the progression of CKD, and CVD. Some, but not all, studies have demonstrated racial differences in circulating AVP/copeptin. Further, prior studies that aimed at increasing water resulted in reductions in copeptin and improvements in cardiometabolic health. For example, in a cohort with high plasma copeptin, increased water intake also reduced fasting plasma glucose. In a cohort of adults with overweight and obesity, increased water or low-calorie beverage intake reduced fasting plasma glucose and contributed to modest weight loss. Lastly, over 90% of adults do not meet recommendations for potassium intake. Importantly, potassium improves blood pressure (BP), particularly in Black adults, who tend to consume less potassium and have higher BP. Yet, there remains a knowledge gap regarding whether hydration intervention(s) inclusive of water (with or without) potassium could attenuate racial disparities in hydration status and circulating AVP/copeptin. Therefore, the investigators are seeking to test the investigators' central hypothesis that water with a potassium supplement (2000mg/day) will improve hydration and cardiovascular health in White adults (n = 20, 10 females, 10 males), and to a greater extent in young Black Adults (n = 20, 10 females, 10 males). The investigators will utilize three complementary specific aims to address the investigators' hypotheses:

Aim 1: Determine whether water with potassium supplementation improves hydration status and reduces circulating copeptin. The investigators hypothesize that water and potassium supplementation will improve hydration and renal biomarkers, including increased urine volume, and reduced urine specific gravity, urine osmolality, and plasma copeptin.

Aim 2: Determine whether water with potassium supplementation improves BP and vascular health. The investigators hypothesize that water and potassium supplementation will reduce resting laboratory BP and ambulatory BP (awake, asleep, and nocturnal BP dipping), and reduce arterial stiffness assessed via pulse wave velocity.

Aim 3: Determine whether socioeconomic factors are associated with hydration perceptions, knowledge, and practices. The investigators hypothesize that area deprivation index (ADI, i.e., more deprivation) will be associated with hydration perceptions (e.g., greater distrust of tap water) and inadequate hydration assessed by self-reported fluid intake and urine-specific gravity.

In summary, a knowledge gap remains in determining the underlying reasons for the consistently reported racial differences in hydration. To restate, the purpose of this study is to determine 1) whether prescribing water with potassium supplementation is efficacious at improving hydration and reducing plasma copeptin in Black and White adults; 2) whether improving hydration with supplemental potassium improves BP and vascular function in young Black and White adults; 3) Another area of innovation in the investigators' proposal is determining whether area deprivation index (ADI, i.e., more deprivation) is associated with and 3a) beliefs and practices around hydration and 3b) hydration status. 4) We also seek to determine whether the intervention leads to greater improvements in Black adults who are more likely to be underhydrated.

Вмешательства

  • Пищевая добавка Water and Potassium supplementation
    All Participants will be given cases of water and instructed to drink at least an extra 1L per day. Additionally, participants will be given 2000 mg of potassium via potassium chloride powder.

Первичные конечные точки

  • Urine specific gravity [Срок оценки: Change score from habitual consumption to after the hydration interventions (2 weeks)]
  • Urine osmolality [Срок оценки: Change score from habitual consumption to after the hydration interventions (2 weeks)]
  • Urine flow rate [Срок оценки: Change score from habitual consumption to after the hydration interventions (2 weeks)]
  • Plasma copeptin [Срок оценки: Change score from habitual consumption to after the hydration interventions (2 weeks)]
  • 24-hour ambulatory blood pressure [Срок оценки: Change score from habitual consumption to after the hydration interventions (2 weeks)]
  • Pulse wave velocity [Срок оценки: Change score from habitual consumption to after the hydration interventions (2 weeks)]
  • Pulse wave analysis [Срок оценки: Change score from habitual consumption to after the hydration interventions (2 weeks)]
  • Brachial blood pressure [Срок оценки: Change score from habitual consumption to after the hydration interventions (2 weeks)]
Вторичные конечные точки (11)
  • Kidney blood velocity [Срок оценки: Change score from habitual consumption to after the hydration interventions (2 weeks)]
  • Plasma Osmolality [Срок оценки: Change score from habitual consumption to after the hydration interventions (2 weeks)]
  • Plasma electrolytes [Срок оценки: Change score from habitual consumption to after the hydration interventions (2 weeks)]
  • Blood glucose [Срок оценки: Change score from habitual consumption to after the hydration interventions (2 weeks)]
  • Objective sleep duration [Срок оценки: Pre-intervention (14 days)]
  • Objective sleep efficiency [Срок оценки: Pre-intervention (14 days)]
  • Subjective sleep duration [Срок оценки: Change score from habitual consumption to after the hydration interventions (2 weeks)]
  • Subjective sleep quality [Срок оценки: Change score from habitual consumption to after the hydration interventions (2 weeks)]
  • Urine electrolytes [Срок оценки: Change score from habitual consumption to after the hydration interventions (2 weeks)]
  • Inflammatory cytokine responses [Срок оценки: Change score from habitual consumption to after the hydration interventions (2 weeks)]
  • Dietary intake [Срок оценки: Change score from habitual consumption to after the hydration interventions (2 weeks)]

Критерии участия

Критерии включения

  • Between the ages of 18-30 years
  • Resting blood pressure no higher than 150/90 mmHg
  • BMI below 35 kg/m2
  • Free of any metabolic disease (e.g., diabetes) kidney disease, pulmonary disorders (e.g., COPD), cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular), no autoimmune diseases, and no history of cancer.

Критерии исключения

  • Have any precluding medical conditions (i.e. hemophilia) or medication (Pradaxa, Eliquis, etc.) that prevent participants from giving blood.
  • Are currently pregnant or trying to become pregnant.
  • take any of the following medications that are contraindicated with potassium supplementation:
  • Renin-angiotensin-aldosterone system (RAAS) blockers: Candesartan , Eprosartan, Irbesartan, Losartan, Olmesartan, Telmisartan
  • Non -steroidal anti-inflammatory medications: Aspirin, Ibuprofen, Naproxen
  • Non-selective beta-blockers: Pindolol, Penbutolol, Oxprenolol, Propranolol, Nadolol, Sotalol, Timolol, Tertatolol
  • Calcineurin inhibitors: Cyclosporine
  • Heparin (or other blood thinning medications)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Kinesiology Building — Auburn

Публикации

  • Robinson AT, Linder BA, Barnett AM, Jeong S, Sanchez SO, Nichols OI, McIntosh MC, Hutchison ZJ, Tharpe MA, Watso JC, Gutierrez OM, Fuller-Rowell TE. Cross-sectional analysis of racial differences in hydration and neighborhood deprivation in young adults. Am J Clin Nutr. 2023 Oct;118(4):822-833. doi: 10.1016/j.ajcnut.2023.08.005. Epub 2023 Aug 22. PMID 37619651
  • Fuller-Rowell TE, Nichols OI, Robinson AT, Boylan JM, Chae DH, El-Sheikh M. Racial disparities in sleep health between Black and White young adults: The role of neighborhood safety in childhood. Sleep Med. 2021 May;81:341-349. doi: 10.1016/j.sleep.2021.03.007. Epub 2021 Mar 12. PMID 33798979
  • Brooks CJ, Gortmaker SL, Long MW, Cradock AL, Kenney EL. Racial/Ethnic and Socioeconomic Disparities in Hydration Status Among US Adults and the Role of Tap Water and Other Beverage Intake. Am J Public Health. 2017 Sep;107(9):1387-1394. doi: 10.2105/AJPH.2017.303923. Epub 2017 Jul 20. PMID 28727528
  • Onufrak SJ, Park S, Sharkey JR, Sherry B. The relationship of perceptions of tap water safety with intake of sugar-sweetened beverages and plain water among US adults. Public Health Nutr. 2014 Jan;17(1):179-85. doi: 10.1017/S1368980012004600. Epub 2012 Oct 26. PMID 23098620
  • Onufrak SJ, Park S, Sharkey JR, Merlo C, Dean WR, Sherry B. Perceptions of tap water and school water fountains and association with intake of plain water and sugar-sweetened beverages. J Sch Health. 2014 Mar;84(3):195-204. doi: 10.1111/josh.12138. PMID 24443781
  • Park S, Onufrak SJ, Cradock AL, Patel A, Hecht C, Blanck HM. Perceptions of Water Safety and Tap Water Taste and Their Associations With Beverage Intake Among U.S. Adults. Am J Health Promot. 2023 Jun;37(5):625-637. doi: 10.1177/08901171221150093. Epub 2023 Jan 6. PMID 36609168

Идентификаторы

NCT: NCT06062017 · #23-381

Первоисточники (государственные реестры)

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