NCT04015544已完成不适用
Expression of Systemic Markers of Atherosclerosis in Free-living, Overweight, Postmenopausal Women Following Daily Watermelon Consumption for Six Weeks: A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in select plasma cardiovascular disease markers
研究概览
简要总结
The primary purpose of this study is to determine the effectiveness of six weeks of watermelon puree supplementation, compared to control (no treatment), on blood antioxidant capacity, inflammation markers in the blood, biomarkers of metabolism in the blood, and cardiovascular disease markers in the blood, and biomarkers in the blood related to watermelon ingestion in overweight post-menopausal women. The secondary purpose is to compare body composition and body mass between the watermelon supplement group and the control group.
详细描述
ORIENTATION AND PRE-STUDY TESTING (1-2 hours):
- Come to the Lab in the morning in an overnight fasted state.
- Complete orientation to the study, and provide voluntary consent to join the study.
- Complete a medical health questionnaire to verify medical history and lifestyle habits, and provide a 3-day food record.
- Record symptoms on a questionnaire regarding how subjects have felt for the previous four weeks using a 12-point Likert scale. Symptoms relate to digestive health, hunger, energy, infection, pain, allergies, stress, mental focus, and overall wellbeing.
- All forms reviewed to determine eligibility to participate in this study.
- Subject height, body weight, and percent body fat measured.
- A blood sample taken by a trained phlebotomist; the sample not to exceed 40 mL. Blood tested for markers associated with inflammation and cardiovascular health, and nutritional compounds related to drinking watermelon puree.
- Subjects randomized to the Control or Watermelon group. If assigned to the Watermelon group subjects provided a six-week supply of watermelon puree.
- The morning of the study subjects consume the three bottles of watermelon puree (710 mL total, Watermelon group) each day thereafter for six weeks or maintain normal daily fluid intake (Control group).
- Six weeks after beginning the study subjects return to the Laboratory for the final measurements. Subjects to bring all beverage bottles.
6-WEEK LAB VISIT (1-2 hours):
- Participants come to the Lab in the morning in an overnight fasted state.
- Subject body weight, and percent body fat are measured.
- Subjects record symptoms on a questionnaire regarding how they have felt for the previous six weeks.
- A final blood sample (40 mL) taken by a trained phlebotomist.
BLOOD SAMPLE ANALYSES
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •50 to 75 years of age,
- •have not menstruated for at least 1 year (menopause),
- •have a BMI of ≥25 kg/m2,
- •nonsmoker with
- •no diagnosed history of chronic diseases including: coronary heart disease, stroke, cancer, type 1 or 2 diabetes mellitus, or rheumatoid arthritis;
- •may not regularly consume large quantities of L-citrulline/L-arginine rich foods (red meat, tuna fish, cheese, nuts),
- •may not regularly take L-citrulline/L-arginine supplements,
- •may not use anti-hypertension medications (including diuretic medications),
- •may not use exogenous ovarian hormones, or
- •may not use medications known to influence inflammation within the two weeks of the study period (specifically non-steroidal anti-inflammatory drugs; NSAIDS).
排除标准
- •younger than 50 or older than 75 years of age,
- •menstruated within the last year,
- •have a BMI of <25 kg/m2, smoker,
- •diagnosed history of chronic diseases including: coronary heart disease, stroke, cancer, type 1 or 2 diabetes mellitus, or rheumatoid arthritis;
- •regularly consume large quantities of L-citrulline/L-arginine rich foods (red meat, tuna fish, cheese, nuts),
- •regularly take L-citrulline/L-arginine supplements,
- •use anti-hypertension medications (including diuretic medications),
- •use exogenous ovarian hormones, or
- •use medications known to influence inflammation within the two weeks of the study period (specifically non-steroidal anti-inflammatory drugs; NSAIDS).
研究组 & 干预措施
Control
No Intervention
No intervention
Watermelon
Experimental
Watermelon puree 710 mL per day for six weeks
干预措施: Watermelon (Dietary Supplement)
结局指标
主要结局
Change in select plasma cardiovascular disease markers
时间窗: Pre-study and study completion (6 weeks)
Plasma concentrations of ADAMTS13, sVCAM-1, sP-selectin, GDF-15, hs-CRP, and sICAM-1
次要结局
- Blood insulin(Pre-study and study completion (6 weeks))
- Blood carotenoids(Pre-study and study completion (6 weeks))
- Blood amino acids(Pre-study and study completion (6 weeks))
- Blood glucose(Pre-study and study completion (6 weeks))
- Body mass(Pre-study and study completion (6 weeks))
- Body mass index(Pre-study and study completion (6 weeks))
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
The Effects of Watermelon Juice Supplementation on Postprandial Vascular Endothelial FunctionEndothelial DysfunctionNCT04092439Pennington Biomedical Research Center18
已完成
3 期
Atherosclerosis Monitoring and Atherogenicity Reduction StudyCarotid AtherosclerosisNCT01734707Institute for Atherosclerosis Research, Russia300
已完成
不适用
Acute Effects of Watermelon on Vascular Function and Serum LycopeneVascular Health of Postmenopausal WomenNCT03608254University of Alabama, Tuscaloosa11
已完成
不适用
Effect of 6-week Strawberry Supplementation on Insulin Action (STR2)Nutritional DiseaseMetabolic DiseaseInsulin ResistanceNCT01457612Clinical Nutrition Research Center, Illinois Institute of Technology45
终止
不适用
The Influence of Daily Strawberry Intake on Vascular Health in Elderly MenVascular DilationNCT04763499University of California, Davis4