Adequate Hydration and Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Accuracy of cognitive test
研究概览
简要总结
Cardiovascular diseases (CVD) are the leading cause of death in middle- and high-income countries, according to data from the World Health Organization (WHO). Epidemiological studies have associated low water intake and underhydration with diabetes, chronic kidney disease, and an increased risk of CVD. Similarly, the prevalence of chronic metabolic dysfunction is increasing dramatically worldwide, becoming both a significant public health concern and a global economic burden. Reports from the WHO indicate that the number of people with diabetes worldwide has risen from 108 million in 1980 to 422 million in 2014, representing 8.5% of adults. Therefore, there is an urgent need to identify modifiable risk factors that could help prevent metabolic dysfunction and mitigate the epidemic of type 2 diabetes (T2D). Evidence suggests that the hormone arginine vasopressin (AVP) may play a key role. AVP is the primary hormone responsible for regulating body fluid balance; however, increased AVP secretion, such as under conditions of low water intake, appears to be a risk factor for developing diabetes.
Increasing water intake may represent a simple and cost-effective way to improve glucose regulation and cardiovascular health. However, many individuals do not prefer drinking plain water, and although beverages with high sugar content may promote greater fluid intake, they also contribute additional calories that can negatively impact body weight and overall health. Thus, the central research question of this study is whether improving hydration with non-sugar-sweetened beverages can provide equivalent benefits for hydration and health outcomes in adults.
Aim 1: To explore the association between habitual fluid intake and fluid preferences (water and non-sugar-sweetened beverages), hydration biomarkers, and health outcomes in normal-weight and obese adults.
Aim 2: To compare the impact of increased total water intake, provided as plain water or non-sugar-sweetened beverages, on hydration, cardiovascular health, and glucose regulation in normal-weight and obese adults.
详细描述
Protocol
Subjects will first come into the lab for a screening visit (approximately 1 hour). In this visit, they will learn more about the study, provide written informed consent (if they choose to participate), fill out a medical history form, have their weight, height, and body composition measured, and have a finger stick blood test to measure glycosylated hemoglobin (HbA1c). Those with A1c values >7% at screening will not be included in the study. We will provide them with information about HbA1c levels that meet the diagnostic criterion for diabetes immediately. Those with A1c values from 6.5 to ≤7% will be provided with information about HbA1c levels that meet the diagnostic criterion for diabetes at the end of the trial. We will suggest they share this information with their doctor. We will answer any questions they may have.
Two groups of 72 volunteers each will be grouped as having normal weight or obesity based on their BMI. The subjects who enroll in the study will undergo an 8-week cross-ver study with two separate arms based on BMI category. Subjects in each BMI category will be evaluated weekly as described below and depicted in Figure 1:
Week 1: Baseline. During this week, the subjects will maintain their habitual fluid intake without any intervention.
Weeks 2-4 & Weeks 6-8: All subjects will follow 3 weeks of consuming only plain water and a 3-week of non-sugar sweetened beverages, in a random order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 18.5-24.9 or 30.0-39.9 kg/m2
- •HbA1c ≤7%
- •Age 20-65 y
- •available for 8 consecutive weeks same day and time
排除标准
- •HbA1c >7% BMI ≤18.5, BMI of 25 to <30, or ≥ 40 kg/m2
- •night shifting work
- •losing or gaining weight during the last 2 months (>5 lbs. fluctuation)
- •thyroid medication
- •bariatric surgery
- •Habitual strenuous exercise (>120 min/week) Strenuous exercise is defined as activities that take hard physical effort and make you breathe much harder than normal.
- •Construction and other workers that spend signifant portion of their work day outdoors
- •Commuting by bicycle
- •Eating disorders
- •Use of aspirin during the duration of the study
- •Renal disease (including kidney stones or recurrent urinary track infections
- •Hepatic disease
- •Cardiac conditions
- •Current infection requiring medication
- •Chronic, contagious, infectious diseases such as tuberculosis, Hepatitis A, B, C, or HIV
- •Medication that could affect appetite or body weight regulation
- •GLP1-RA medication
- •Anti-depressent SSRI medication
- •Testosterone replacement therapy
- •Participating in another study at the same time
- •Unable to abstain from alcohol during the study
- •Unable to limit caffeinated beverage intake to 1 cup per day
- •Donated blood during the past two months
- •Uneasibly acessable veins
- •Does not have smart phone
研究组 & 干预措施
Baseline - week 1
Habitual fluid intake during week 1 of the study
干预措施: Baseline - week 1 (Other)
Low Water intake - week 2
Low water intake as described by the protocol
干预措施: Low Water Intake - week 2 (Other)
Moderate water intake - week 3
Moderate water intake as described by the protocol
干预措施: Moderate Water Intake - week 3 (Other)
Adequate Water intake - Week 4
Adequate water intake as described by the protocol
干预措施: Adequate Water Intake - week 4 (Other)
Washout period - week 5
Habitual fluid intake week
干预措施: Washout - week 5 (Other)
Low fluid intake with non caloric sweeteners - Week 6
Low fluid intake with non-caloric sweeteners - Week 6
干预措施: Low fluid intake with non caloric sweeteners - Week 6 (Other)
Moderate fluid intake with non caloric sweeteners - Week 7
Moderate fluid intake with non caloric sweeteners - Week 7
干预措施: Moderate fluid intake with non caloric sweeteners - Week 7 (Other)
Adequate fluid intake with non caloric sweeteners - Week 8
Adequate fluid intake with non caloric sweeteners - Week 8
干预措施: Adequate fluid intake with non caloric sweeteners - Week 8 (Other)
结局指标
主要结局
Accuracy of cognitive test
时间窗: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Accuracy on the Erikson Flankers cognitive test
Flow-mediated dilation %
时间窗: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Flow-mediated dilation (FMD) will be assessed as a non-invasive measure of endothelial function using brachial artery ultrasound. A high-resolution ultrasound probe will measure baseline artery diameter, then artery diameter after 5 minutes of forearm cuff occlusion, followed by rapid cuff deflation. FMD% will be calculated as a percent of \[(Maximum Post-Deflation Diameter - Baseline Diameter)/Baseline Diameter\]×100 This outcome provides the percent increase in brachial artery diameter relative to baseline, reflecting endothelium-dependent vasodilation.
Area under the curve for glucose
时间窗: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
The positive integer of the glucose levels during the 120 minutes post ingestion of 75 g of glucose
Insulin area under the curve
时间窗: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
The positive integer of the insulin levels during the 120 minutes post ingestion of 75 g of glucose
glucagon area under the curve
时间窗: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
The positive integer of the glucagon levels during the 120 minutes post ingestion of 75 g of glucose
Cortisol area under the curve
时间窗: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
The positive integer of the cortisol levels during the 120 minutes post ingestion of 75 g of glucose
Mean glucose
时间窗: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Mean weekly interstitial glucose from the continuous glucose monitor
Glycemic Variability
时间窗: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
coefficent of variation (%) of weekly interstitial glucose from the continuous glucose monitor
Serum copeptin
时间窗: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Serum copeptin/vasopressin at baseline of the oral glucose tolerance test
Plasma Sodium
时间窗: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Plasma sodium at baseline of the oral glucose tolerance test
Plasma Osmolality
时间窗: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Plasma osmolality at baseline of the oral glucose tolerance test
Total Water Intake
时间窗: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Weekly average total water intake from Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Urine volume
时间窗: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
24 hours urine volume the day prior to the oral glucose tolerance test
Urine Osmolality
时间窗: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Urine Osmolality from a 24 hours urine sample the day prior to the oral glucose tolerance test
Reaction time
时间窗: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Reaction time assessed via Erikson Flankers Test
Homeostasis Model Assessment of Insulin Resistance
时间窗: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention based on the baseline (0 minutes) fasting blood sample.
The Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), as described by Matthews et al., is a validated index used to estimate insulin resistance from fasting plasma glucose and insulin concentrations. It is commonly applied in clinical trials as a practical and reliable surrogate measure of insulin sensitivity when clamp techniques are not feasible.
次要结局
- Intracellular Water(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
- Total mood disturbance(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
- Confusion-bewilderment(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
- Thirst(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
- Hunger(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
- Total Body Water(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
- Depression-dejection(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
- Fatigue-inertia(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
- Vigour-activity(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
- Extra cellular water(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
- Cravings(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
- Urine acesulfame potassium(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
- Urine Sucralose(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
- Resting Energy Expenditure(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
- Resting Energy expediture from fat oxidation(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
- Resting energy expenditure from carbohydrates oxidation(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
- Total Caloric Intake(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
- Total Sodium intake(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
- Total Protein intake(1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention)
研究者
Stavros Kavouras
Professor
Arizona State University