Cardiometabolic Effects of Sweet Cherry Juice

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolic Syndrome
• Intervention / Treatment: Other: Cherry juice; Other: Placebo beverage

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ellen L Bonnel, PhD; Phone Number: 530-752-4184; Email: ellen.bonnel@ars.usda.gov
• Study Contact Backup: Name: Kevin D Laugero, PhD; Phone Number: 530-752-4173; Email: kevin.laugero@ars.usda.gov

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • USDA, ARS, Western Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Cherry juice; FruitSmart® Cherry Concentrate: Dark Sweet Cherry Juice Concentrate produced from dark sweet cherries to retain the characteristic color and flavor of the whole fruit.; Other: Placebo beverage; 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.
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.	Other: Cherry juice; FruitSmart® Cherry Concentrate: Dark Sweet Cherry Juice Concentrate produced from dark sweet cherries to retain the characteristic color and flavor of the whole fruit.; Other: Placebo beverage; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: USDA, Western Human Nutrition Research Center
• Collaborators: Washington State Fruit Commission

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): October 25, 2023
• Study Completion (Actual): October 25, 2023

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: inflammatory disease; chronic stress; cherries
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: FL108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No