Cardiometabolic Effects of Sweet Cherry Juice
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- USDA, Western Human Nutrition Research Center
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Change in electrical activity of heartbeat
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study aims to determine the effects of consuming sweet cherry juice on cardiovascular function, glucose regulation, and lipid status in overweight human subjects. The investigators hypothesize that sweet cherry juice consumption will improve metabolic and physiological status in overweight persons compared to a placebo.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in electrical activity of heartbeat
Time Frame: Week 0, 6 and 12
Assessed using electrocardiogram (ECG)
Change in diastolic blood pressure
Time Frame: Week 0, 6 and 12
Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg
Change in systolic blood pressure
Time Frame: Week 0, 6 and 12
Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg
Change in cardiac parasympathetic control
Time Frame: Week 0, 6 and 12
Assessed using impedance cardiography (ICG) and ECG
Change in mean arterial blood pressure
Time Frame: Week 0, 6 and 12
Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg
Change in heart rate variability
Time Frame: Week 0, 6 and 12
Heart rate variability (HRV) assessed using a mobile device via ECG in millivolts
Secondary Outcomes
- Change in attentive function(Week 0, 6 and 12)
- Change in psycho-motor speed(Week 0, 6 and 12)
- Change in executive function(Week 0, 6 and 12)
- Change in liver stiffness(Week 0, 6 and 12)
- Change in salivary cortisol in response to stress(prior to and 30, 60, 90 and 120 minutes after challenging task)
- Change in body weight(Week 0, 6 and 12)
- Change in mitochondrial respiration(Week 0, 6 and 12)
- Change in liver fat(Week 0, 6 and 12)
- Change in chronic stress(Week 0, 6 and 12)
- Change in vascular function(Week 0, 6 and 12)
- Change in multitasking(Week 0, 6 and 12)
- Change in peripheral insulin resistance (IR)(Week 0, 6 and 12)
- Change in social cognition(Week 0, 6 and 12)
- Change in spatial memory(Week 0, 6 and 12)
- Change in verbal memory(Week 0, 6 and 12)
- Change in mood(Week 0, 6 and 12)
- Change in waist circumference(Week 0, 6 and 12)
- Change in activity level(Week 0, 6 and 12)
- Change in neurological related biomarkers(Week 0, 6 and 12)
- Change in perceived stress(Week 0, 6 and 12)
- Change in self-reported sleep quality(Week 0, 6 and 12)
- Change in hepatic insulin resistance (IR)(Week 0, 6 and 12)
- Change in salivary cortisol in response to glucose tolerance test(prior to and 120 minutes after glucose tolerance test)
- Change in inflammation related biomarkers(Week 0, 6 and 12)
- Change in cardiovascular related biomarkers(Week 0, 6 and 12)