Cardiometabolic Effects of Sweet Cherry Juice

USDA, Western Human Nutrition Research Center4 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Obesity Metabolic Syndrome

Interventions

Cherry juiceOTHER

FruitSmart® Cherry Concentrate: Dark Sweet Cherry Juice Concentrate produced from dark sweet cherries to retain the characteristic color and flavor of the whole fruit.

Placebo beverageOTHER

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

USDA, ARS, Western Human Nutrition Research Center

Davis, California, United States

Outcomes

Primary Outcomes

Change in systolic blood pressure

Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg

Time frame: Week 0, 6 and 12

Change in diastolic blood pressure

Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg

Time frame: 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

Time frame: Week 0, 6 and 12

Change in heart rate variability

Heart rate variability (HRV) assessed using a mobile device via ECG in millivolts

Time frame: Week 0, 6 and 12

Change in cardiac parasympathetic control

Assessed using impedance cardiography (ICG) and ECG

Time frame: Week 0, 6 and 12

Change in electrical activity of heartbeat

Assessed using electrocardiogram (ECG)

Time frame: Week 0, 6 and 12

Secondary Outcomes

Change in vascular function

Peripheral arterial tone (PAT) determined using the EndoPAT expressed as the reactive hyperemia index (RHI)

Time frame: Week 0, 6 and 12

Change in liver stiffness

Liver stiffness assessed from the shear wave speed with pulse echo ultrasound using the Fibroscan®

Data from ClinicalTrials.gov

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Time frame: 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®

Time frame: Week 0, 6 and 12

Change in executive function

Assessed using Cambridge Gambling Task (CGT), from Cambridge Neuropsychological Test Automated Battery (CANTAB)

Time frame: Week 0, 6 and 12

Change in attentive function

Assessed using Stop Signal Task (STT) from CANTAB

Time frame: Week 0, 6 and 12

Change in multitasking

Assessed using Multitasking Test (MTT) from CANTAB

Time frame: Week 0, 6 and 12

Change in psycho-motor speed

Assessed using Reaction Time (RTI) task from CANTAB

Time frame: Week 0, 6 and 12

Change in spatial memory

Assessed using Spatial Working Memory (SWM) task from CANTAB

Time frame: Week 0, 6 and 12

Change in verbal memory

Assessed using Verbal Recognition Memory (VRM) task from CANTAB

Time frame: Week 0, 6 and 12

Change in social cognition

Assessed using Emotional Recognition task (ERT) from CANTAB

Time frame: Week 0, 6 and 12

Change in peripheral insulin resistance (IR)

Measured by Matsuda's sensitivity index

Time frame: Week 0, 6 and 12

Change in hepatic insulin resistance (IR)

Measured by homeostasis model assessment (HOMA)

Time frame: 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

Time frame: 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

Time frame: prior to and 30, 60, 90 and 120 minutes after challenging task

Change in body weight

Measured in kg

Time frame: Week 0, 6 and 12

Change in waist circumference

Measured in cm

Time frame: 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.

Time frame: Week 0, 6 and 12

Change in mitochondrial respiration

Cellular bioenergetics measured as oxygen consumption rate (OCR)

Time frame: Week 0, 6 and 12

Change in cardiovascular related biomarkers

Quantitative immunoassay of human cardiovascular biomarkers on a multi-analyte profile

Time frame: Week 0, 6 and 12

Change in inflammation related biomarkers

Quantitative immunoassay of human inflammation biomarkers on a multi-analyte profile

Time frame: Week 0, 6 and 12

Change in neurological related biomarkers

Quantitative immunoassay of human neurological biomarkers on a multi-analyte profile

Time frame: 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.

Time frame: 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.

Time frame: Week 0, 6 and 12

Change in self-reported sleep quality

Sleep quality assessed by self-report using the Pittsburgh Sleep Quality Index

Time frame: 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.

Time frame: Week 0, 6 and 12