Cardiometabolic Effects of Sweet Cherry Juice
关键词
抽象
描述
The investigators will conduct a randomized, cross-over study lasting 14 weeks and including 1 week for screening/enrollment, 1 week baseline assessment, and two intervention periods of 6 weeks each for the cherry juice and placebo interventions. Two test visits, 3 to 7 days apart, will occur before the start of intervention (baseline, or week 0) and then at weeks 6 and 12. Participants will be randomized to consume either the cherry juice or placebo beverage first, and will cross over to the alternate intervention immediately following the end of the first 6 weeks. Test Visit 1 will include measures of blood pressure, vascular tone, liver fat and stiffness, post-prandial metabolic response to the study beverage, cardiovascular activity and function, and nervous system control of cardiovascular activity and tone. Acute effects of study beverages will be measured, as will the chronic effects of study beverage consumption after 6 weeks. At Test Visit 2, participants will take a standard 75 gram oral glucose tolerance test (OGTT). Participants will be equipped with physiological monitoring devices, which will monitor cardiovascular activity and function and nervous system control of cardiovascular activity and tone, and continuously measure blood pressure. A series of cognitive function tasks will be administered, and a mental stress test will be conducted. The Test Visit 1 and 2 will be repeated at week 6 and week 12 following each intervention with cherry juice or the placebo beverage.
日期
| 最后验证: | 09/30/2019 |
| 首次提交: | 04/24/2019 |
| 提交的预估入学人数: | 05/08/2019 |
| 首次发布: | 05/12/2019 |
| 上次提交的更新: | 10/03/2019 |
| 最近更新发布: | 10/07/2019 |
| 实际学习开始日期: | 09/30/2019 |
| 预计主要完成日期: | 05/30/2021 |
| 预计完成日期: | 05/30/2022 |
状况或疾病
干预/治疗
Other: Cherry juice
Other: Placebo beverage
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Cherry juice followed by placebo Sweet cherry juice concentrate will be consumed twice daily for 6 weeks, followed by consumption of placebo beverage twice daily for 6 weeks. | |
| Experimental: Placebo beverage followed by cherry juice Placebo beverage will be consumed twice daily for 6 weeks, followed by consumption of sweet cherry juice concentrate twice daily for 6 weeks. |
资格标准
| 有资格学习的年龄 | 20 Years 至 20 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Men aged 20 - 65 years - Post-menopausal women aged 45 - 65 years - Body Mass Index ≥25 and <40 kg/m2 - Systolic blood pressure >120 and <140 mmHg or diastolic blood pressure >80 and <90 mmHg Exclusion Criteria: - Diagnosed metabolic disorder - Diabetes mellitus - Thyroid disease - Cardiovascular disease - Poly-cystic ovary syndrome - Vasoconstrictive diseases (e.g. Raynaud's phenomenon or Raynaud's disease) - Digestive disorder (e.g. Crohn's, irritable bowel syndrome, colitis) - History of gastrointestinal surgery affecting digestion and/or absorption - Use of medications for hypertension, hyperlipidemia, glycemic control, or weight loss - Use of medications such as steroids, statins, or non-steroidal anti-inflammatory agents - Routine use of over-the-counter medications - Weight change >5% in the past 6 months - Performing exercise greater than 60 minutes/day - Presence of a pacemaker or other internal electronic device controlling rhythm or pacing of heart excludes participant from MindWare procedure - Presence of atrial fibrillation or other arrhythmia excludes participant from MindWare procedure |
结果
主要结果指标
1. Change in systolic blood pressure [Week 0, 6 and 12]
2. Change in diastolic blood pressure [Week 0, 6 and 12]
3. Change in mean arterial blood pressure [Week 0, 6 and 12]
4. Change in heart rate variability [Week 0, 6 and 12]
5. Change in cardiac parasympathetic control [Week 0, 6 and 12]
6. Change in electrical activity of heartbeat [Week 0, 6 and 12]
次要成果指标
1. Change in vascular function [Week 0, 6 and 12]
2. Change in liver stiffness [Week 0, 6 and 12]
3. Change in liver fat [Week 0, 6 and 12]
4. Change in executive function [Week 0, 6 and 12]
5. Change in attentive function [Week 0, 6 and 12]
6. Change in multitasking [Week 0, 6 and 12]
7. Change in psycho-motor speed [Week 0, 6 and 12]
8. Change in spatial memory [Week 0, 6 and 12]
9. Change in verbal memory [Week 0, 6 and 12]
10. Change in social cognition [Week 0, 6 and 12]
11. Change in peripheral insulin resistance (IR) [Week 0, 6 and 12]
12. Change in hepatic insulin resistance (IR) [Week 0, 6 and 12]
13. Change in salivary cortisol in response to glucose tolerance test [prior to and 120 minutes after glucose tolerance test]
14. Change in salivary cortisol in response to stress [prior to and 30, 60, 90 and 120 minutes after challenging task]
15. Change in body weight [Week 0, 6 and 12]
16. Change in waist circumference [Week 0, 6 and 12]
17. Change in activity level [Week 0, 6 and 12]
18. Change in mitochondrial respiration [Week 0, 6 and 12]
19. Change in cardiovascular related biomarkers [Week 0, 6 and 12]
20. Change in inflammation related biomarkers [Week 0, 6 and 12]
21. Change in neurological related biomarkers [Week 0, 6 and 12]
22. Change in perceived stress [Week 0, 6 and 12]
23. Change in chronic stress [Week 0, 6 and 12]
24. Change in self-reported sleep quality [Week 0, 6 and 12]
25. Change in mood [Week 0, 6 and 12]
