Dose Response Effect of Watermelon Consumption on Ambulatory Blood Pressure in Adults With Pre-hypertension: A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- To evaluate the change in the dose response effects of watermelon flesh in regulating BP in individuals with pre-hypertension.
研究概览
简要总结
- Primary outcome: To evaluate the dose response effects of watermelon flesh in regulating Blood Pressure (BP) in individuals with pre-hypertension.
- Secondary outcomes: To study the dose-response effects of watermelon flesh intake on cardio-metabolic risk factors including plasma metabolic markers, lipid profile and nitrate/nitrite levels in individuals with pre-hypertension.
详细描述
The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening.
The proposed study is a randomized, three-arm (n=12/arm), single-blinded, placebo-controlled, 4-week, parallel study design in individuals with pre-hypertension (systolic BP ≥ 120-139 mm Hg or a diastolic BP ≥ 80-89 mm Hg).
Pre-Screening: To learn more about the study and to pre-qualify, potential subjects can call the Clinical Nutrition Research Center (CNRC) or visit the website posted on recruitment flyers or from other recruitment materials. If individuals call the CNRC, a staff member will provide a brief background on the study and ask a series of questions from a pre-screening questionnaire to assess eligibility. The same questionnaire is available on the website and can be filled out by potential subjects online. The pre-screening questionnaire includes self-reported information about health status and lifestyle factors that can be used to determine if someone is not eligible for the study.
Screening: Participants will be asked to read, ask questions, sign and date the Institutional Review Board (IRB) approved Informed Consent Form (ICF) before any laboratory or study screening procedures begin. Participants will be informed of study procedures and schedules. Once ICF is signed by participant and staff, height, weight and waist circumference measurements, vital signs measurements, body temperature measurements (by contactless thermometer), and a finger prick (to confirm fasting status and blood sugar) will be collected.
Pre-Study Visit: If participants are eligible and willing to continue, a pre-study visit will be scheduled. The pre-study visit is for training on various aspects of the study. Participants will have diet counseling on foods that are rich in the components typically found in watermelon (e.g. tomatoes, carrots, sweet potatoes, etc.). Participants will be asked to avoid these foods for at least 7 days before the first study visit day. There will also be coaching on how to complete a 3-day food record that will be collected at each study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who are nonsmokers
- •Healthy overweight/ obese man or woman between 25 and 65 years of age
- •Blood pressure 120-160 mmHg systolic or 80-100 mm/Hg diastolic at screening visit
- •Fasting blood glucose concentration between 100 mg/dL and 125 mg/dL at screening visit (value range indicate prediabetes, by finger prick and/or venous blood sampling)
- •Have no clinical evidence/history of cardiovascular, metabolic, respiratory, renal, gastrointestinal, or hepatic disease
排除标准
- •Vegetarian
- •Men and women who have fasting blood glucose concentration <100 or >125 mg/dL at screening visit
- •Uncontrolled blood pressure ≥140 mmHg (systolic)/ ≥ 90 mmHg (diastolic)
- •Over the counter supplements (e.g. fiber supplements, probiotics and/or prebiotics, antioxidants, anti-inflammation)
- •Dietary supplements like (garlic, fish oil), glutamine supplements, grape seed extract, L-citrulline/arginine
- •Cholesterol-lowering medications, anticoagulants, blood pressure-lowering medications,) and/or taking prescription medications that may interfere with study procedures or endpoints (e.g. gastrointestinal medications, antibiotics) within the last 30 days
- •Have cancer other than non-melanoma skin cancer in previous 5 years
- •Taking unstable dose of hormonal contraceptive and/or a stable dose less than 6 months
- •Planning to become pregnant, pregnant and/or breast-feeding
- •Excessive exerciser or a trained athlete
- •Drink excessive amount of coffee/tea (> 5 cups per day)
- •Donated blood within last 3 months
- •Have allergies/intolerances to foods consumed in the study
- •Currently eat > 2 servings of watermelons per day
- •Actively losing weight/ trying to lose weight (unstable body weight fluctuations of > 11 lbs in 3 months)
- •Addicted to drugs or alcohol
- •Have significant psychiatric or neurological disturbances that may interfere with the ability to follow the study protocol
研究组 & 干预措施
Watermelon flesh Dose 2
2 cups watermelon flesh, ~304 g
干预措施: Watermelon Flesh Dose 2 (Other)
Control
Calorie-matched control beverage
干预措施: Control (Other)
Watermelon flesh Dose 1
1 cup watermelon flesh, ~152 g
干预措施: Watermelon Flesh Dose 1 (Other)
结局指标
主要结局
To evaluate the change in the dose response effects of watermelon flesh in regulating BP in individuals with pre-hypertension.
时间窗: Baseline to 4 weeks
This objective will be accomplished by assessing the 24-h Ambulatory Blood Pressure Machine (ABPM) in individuals with pre-hypertension before and after 4 weeks of watermelon flesh intake. Two doses of watermelon flesh will be tested (1 and 2 cup servings) compared to control.
次要结局
- To evaluate the change in lipid profile in individuals with pre-hypertension after consuming watermelon flesh.(Baseline to 4 weeks)
- To evaluate the change in plasma and urine nitrite/nitrate in individuals with pre-hypertension after consuming watermelon flesh.(Baseline to 4 weeks)
- To evaluate the change in glucose in individuals with pre-hypertension after consuming watermelon flesh.(Baseline to 4 weeks)
- To evaluate the change in insulin in individuals with pre-hypertension after consuming watermelon flesh.(Baseline to 4 weeks)
- To evaluate the changes in L-Citrulline, Arginine, and Asymmetric Dimethylarginine (ADMA) in individuals with pre-hypertension after consuming watermelon flesh, analyzed by mass spectrometry.(Baseline to 4 weeks)