Cardiometabolic Effects of Sweet Cherry Juice
কীওয়ার্ডস
বিমূর্ত
বর্ণনা
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.
তারিখ
| সর্বশেষ যাচাই করা হয়েছে: | 09/30/2019 |
| প্রথম জমা দেওয়া: | 04/24/2019 |
| আনুমানিক তালিকাভুক্তি জমা দেওয়া হয়েছে: | 05/08/2019 |
| প্রথম পোস্ট: | 05/12/2019 |
| সর্বশেষ আপডেট জমা দেওয়া হয়েছে: | 10/03/2019 |
| সর্বশেষ আপডেট পোস্ট: | 10/07/2019 |
| আসল অধ্যয়ন শুরুর তারিখ: | 09/30/2019 |
| আনুমানিক প্রাথমিক সমাপ্তির তারিখ: | 05/30/2021 |
| আনুমানিক অধ্যয়ন সমাপ্তির তারিখ: | 05/30/2022 |
অবস্থা বা রোগ
হস্তক্ষেপ / চিকিত্সা
Other: Cherry juice
Other: Placebo beverage
পর্যায়
বাহু গ্রুপ
| বাহু | হস্তক্ষেপ / চিকিত্সা |
|---|---|
| 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. |
যোগ্যতার মানদণ্ড
| বয়স অধ্যয়নের জন্য যোগ্য | 20 Years প্রতি 20 Years |
| লিঙ্গ অধ্যয়নের জন্য যোগ্য | All |
| স্বাস্থ্যকর স্বেচ্ছাসেবীদের গ্রহণ করে | হ্যাঁ |
| নির্ণায়ক | 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 |
ফলাফল
প্রাথমিক ফলাফল ব্যবস্থা
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]
মাধ্যমিক ফলাফলের ব্যবস্থা
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]
