Cardiometabolic Effects of Sweet Cherry Juice

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cardiometabolic Effects of Sweet Cherry Juice

Conditions
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Obesity, Metabolic Syndrome

Intervention / Treatment
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* Other: Cherry juice
* Other: Placebo beverage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cherry juice followed by placebo<br>Sweet cherry juice concentrate will be consumed twice daily for 6 weeks, followed by consumption of placebo beverage twice daily for 6 weeks. | Other: Cherry juice<br>* FruitSmart® Cherry Concentrate: Dark Sweet Cherry Juice Concentrate produced from dark sweet cherries to retain the characteristic color and flavor of the whole fruit.<br>Other: Placebo beverage<br>* Cherry flavored placebo beverage prepared from commercially available cherry syrup with food coloring and thickener to match the color and viscosity of the cherry concentrate.<br>|
| Experimental: Placebo beverage followed by cherry juice<br>Placebo beverage will be consumed twice daily for 6 weeks, followed by consumption of sweet cherry juice concentrate twice daily for 6 weeks. | Other: Cherry juice<br>* FruitSmart® Cherry Concentrate: Dark Sweet Cherry Juice Concentrate produced from dark sweet cherries to retain the characteristic color and flavor of the whole fruit.<br>Other: Placebo beverage<br>* Cherry flavored placebo beverage prepared from commercially available cherry syrup with food coloring and thickener to match the color and viscosity of the cherry concentrate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic blood pressure | Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg | Week 0, 6 and 12 | 
| Change in diastolic blood pressure | Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg | Week 0, 6 and 12 | 
| Change in mean arterial blood pressure | Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg | Week 0, 6 and 12 | 
| Change in heart rate variability | Heart rate variability (HRV) assessed using a mobile device via ECG in millivolts | Week 0, 6 and 12 | 
| Change in cardiac parasympathetic control | Assessed using impedance cardiography (ICG) and ECG | Week 0, 6 and 12 | 
| Change in electrical activity of heartbeat | Assessed using electrocardiogram (ECG) | Week 0, 6 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vascular function | Peripheral arterial tone (PAT) determined using the EndoPAT expressed as the reactive hyperemia index (RHI) | Week 0, 6 and 12 | 
| Change in liver stiffness | Liver stiffness assessed from the shear wave speed with pulse echo ultrasound using the Fibroscan® | Week 0, 6 and 12 | 
| Change in liver fat | Liver fat assessed from the Controlled Attenuation Parameter (CAP) computed from the liver stiffness measurement using the Fibroscan® | Week 0, 6 and 12 | 
| Change in executive function | Assessed using Cambridge Gambling Task (CGT), from Cambridge Neuropsychological Test Automated Battery (CANTAB) | Week 0, 6 and 12 | 
| Change in attentive function | Assessed using Stop Signal Task (STT) from CANTAB | Week 0, 6 and 12 | 
| Change in multitasking | Assessed using Multitasking Test (MTT) from CANTAB | Week 0, 6 and 12 | 
| Change in psycho-motor speed | Assessed using Reaction Time (RTI) task from CANTAB | Week 0, 6 and 12 | 
| Change in spatial memory | Assessed using Spatial Working Memory (SWM) task from CANTAB | Week 0, 6 and 12 | 
| Change in verbal memory | Assessed using Verbal Recognition Memory (VRM) task from CANTAB | Week 0, 6 and 12 | 
| Change in social cognition | Assessed using Emotional Recognition task (ERT) from CANTAB | Week 0, 6 and 12 | 
| Change in peripheral insulin resistance (IR) | Measured by Matsuda's sensitivity index | Week 0, 6 and 12 | 
| Change in hepatic insulin resistance (IR) | Measured by homeostasis model assessment (HOMA) | Week 0, 6 and 12 | 
| Change in salivary cortisol in response to glucose tolerance test | Salivary cortisol measured by enzyme-linked immunoassay in nmol/liter | prior to and 120 minutes after glucose tolerance test | 
| Change in salivary cortisol in response to stress | Salivary cortisol measured by enzyme-linked immunoassay in nmol/liter | prior to and 30, 60, 90 and 120 minutes after challenging task | 
| Change in body weight | Measured in kg | Week 0, 6 and 12 | 
| Change in waist circumference | Measured in cm | Week 0, 6 and 12 | 
| Change in activity level | Measured by Stanford Brief Physical Activity questionnaire. Scale is categorical for two subscales: work physical activity and leisure time activity. | Week 0, 6 and 12 | 
| Change in mitochondrial respiration | Cellular bioenergetics measured as oxygen consumption rate (OCR) | Week 0, 6 and 12 | 
| Change in cardiovascular related biomarkers | Quantitative immunoassay of human cardiovascular biomarkers on a multi-analyte profile | Week 0, 6 and 12 | 
| Change in inflammation related biomarkers | Quantitative immunoassay of human inflammation biomarkers on a multi-analyte profile | Week 0, 6 and 12 | 
| Change in neurological related biomarkers | Quantitative immunoassay of human neurological biomarkers on a multi-analyte profile | Week 0, 6 and 12 | 
| Change in perceived stress | Perceived stress measured using the Perceived stress scale (PSS). Scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Responses for individual questions are summed to a total score. | Week 0, 6 and 12 | 
| Change in chronic stress | Chronic stress measured using the Wheaton Chronic Stress Questionnaire. Individual scores range from 0 to 102, with higher scores indicating higher chronic stress. | Week 0, 6 and 12 | 
| Change in self-reported sleep quality | Sleep quality assessed by self-report using the Pittsburgh Sleep Quality Index | Week 0, 6 and 12 | 
| Change in mood | Mood assessed using the Profile of Mood States (POMS) Standard Score. Total Mood Disturbance (TMD) score is found from the difference between negative subscales - positive subscales. Individual scores on the POMS range from -32 to 200 with higher scores indicating higher mood disturbance. | Week 0, 6 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cherries, inflammatory disease, chronic stress