Cardiometabolic Effects of Sweet Cherry Juice
Primary Purpose
Obesity, Metabolic Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cherry juice
Placebo beverage
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring cherries, inflammatory disease, chronic stress
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
- 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
Sites / Locations
- USDA, ARS, Western Human Nutrition Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cherry juice followed by placebo
Placebo beverage followed by cherry juice
Arm Description
Sweet cherry juice concentrate will be consumed twice daily for 6 weeks, followed by consumption of placebo beverage twice daily for 6 weeks.
Placebo beverage will be consumed twice daily for 6 weeks, followed by consumption of sweet cherry juice concentrate twice daily for 6 weeks.
Outcomes
Primary Outcome Measures
Change in systolic blood pressure
Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg
Change in diastolic blood pressure
Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg
Change in mean arterial blood pressure
Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg
Change in heart rate variability
Heart rate variability (HRV) assessed using a mobile device via ECG in millivolts
Change in cardiac parasympathetic control
Assessed using impedance cardiography (ICG) and ECG
Change in electrical activity of heartbeat
Assessed using electrocardiogram (ECG)
Secondary Outcome Measures
Change in vascular function
Peripheral arterial tone (PAT) determined using the EndoPAT expressed as the reactive hyperemia index (RHI)
Change in liver stiffness
Liver stiffness assessed from the shear wave speed with pulse echo ultrasound using the Fibroscan®
Change in liver fat
Liver fat assessed from the Controlled Attenuation Parameter (CAP) computed from the liver stiffness measurement using the Fibroscan®
Change in executive function
Assessed using Cambridge Gambling Task (CGT), from Cambridge Neuropsychological Test Automated Battery (CANTAB)
Change in attentive function
Assessed using Stop Signal Task (STT) from CANTAB
Change in multitasking
Assessed using Multitasking Test (MTT) from CANTAB
Change in psycho-motor speed
Assessed using Reaction Time (RTI) task from CANTAB
Change in spatial memory
Assessed using Spatial Working Memory (SWM) task from CANTAB
Change in verbal memory
Assessed using Verbal Recognition Memory (VRM) task from CANTAB
Change in social cognition
Assessed using Emotional Recognition task (ERT) from CANTAB
Change in peripheral insulin resistance (IR)
Measured by Matsuda's sensitivity index
Change in hepatic insulin resistance (IR)
Measured by homeostasis model assessment (HOMA)
Change in salivary cortisol in response to glucose tolerance test
Salivary cortisol measured by enzyme-linked immunoassay in nmol/liter
Change in salivary cortisol in response to stress
Salivary cortisol measured by enzyme-linked immunoassay in nmol/liter
Change in body weight
Measured in kg
Change in waist circumference
Measured in cm
Change in activity level
Measured by Stanford Brief Physical Activity questionnaire. Scale is categorical for two subscales: work physical activity and leisure time activity.
Change in mitochondrial respiration
Cellular bioenergetics measured as oxygen consumption rate (OCR)
Change in cardiovascular related biomarkers
Quantitative immunoassay of human cardiovascular biomarkers on a multi-analyte profile
Change in inflammation related biomarkers
Quantitative immunoassay of human inflammation biomarkers on a multi-analyte profile
Change in neurological related biomarkers
Quantitative immunoassay of human neurological biomarkers on a multi-analyte profile
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.
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.
Change in self-reported sleep quality
Sleep quality assessed by self-report using the Pittsburgh Sleep Quality Index
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.
Full Information
NCT ID
NCT03948061
First Posted
April 25, 2019
Last Updated
March 6, 2023
Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
Washington State Fruit Commission
1. Study Identification
Unique Protocol Identification Number
NCT03948061
Brief Title
Cardiometabolic Effects of Sweet Cherry Juice
Official Title
Cardiometabolic Effects of Sweet Cherry Juice
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
Washington State Fruit Commission
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Syndrome
Keywords
cherries, inflammatory disease, chronic stress
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cherry juice followed by placebo
Arm Type
Experimental
Arm Description
Sweet cherry juice concentrate will be consumed twice daily for 6 weeks, followed by consumption of placebo beverage twice daily for 6 weeks.
Arm Title
Placebo beverage followed by cherry juice
Arm Type
Experimental
Arm Description
Placebo beverage will be consumed twice daily for 6 weeks, followed by consumption of sweet cherry juice concentrate twice daily for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Cherry juice
Intervention Description
FruitSmart® Cherry Concentrate: Dark Sweet Cherry Juice Concentrate produced from dark sweet cherries to retain the characteristic color and flavor of the whole fruit.
Intervention Type
Other
Intervention Name(s)
Placebo beverage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in systolic blood pressure
Description
Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg
Time Frame
Week 0, 6 and 12
Title
Change in diastolic blood pressure
Description
Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg
Time Frame
Week 0, 6 and 12
Title
Change in mean arterial blood pressure
Description
Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg
Time Frame
Week 0, 6 and 12
Title
Change in heart rate variability
Description
Heart rate variability (HRV) assessed using a mobile device via ECG in millivolts
Time Frame
Week 0, 6 and 12
Title
Change in cardiac parasympathetic control
Description
Assessed using impedance cardiography (ICG) and ECG
Time Frame
Week 0, 6 and 12
Title
Change in electrical activity of heartbeat
Description
Assessed using electrocardiogram (ECG)
Time Frame
Week 0, 6 and 12
Secondary Outcome Measure Information:
Title
Change in vascular function
Description
Peripheral arterial tone (PAT) determined using the EndoPAT expressed as the reactive hyperemia index (RHI)
Time Frame
Week 0, 6 and 12
Title
Change in liver stiffness
Description
Liver stiffness assessed from the shear wave speed with pulse echo ultrasound using the Fibroscan®
Time Frame
Week 0, 6 and 12
Title
Change in liver fat
Description
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
Title
Change in executive function
Description
Assessed using Cambridge Gambling Task (CGT), from Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time Frame
Week 0, 6 and 12
Title
Change in attentive function
Description
Assessed using Stop Signal Task (STT) from CANTAB
Time Frame
Week 0, 6 and 12
Title
Change in multitasking
Description
Assessed using Multitasking Test (MTT) from CANTAB
Time Frame
Week 0, 6 and 12
Title
Change in psycho-motor speed
Description
Assessed using Reaction Time (RTI) task from CANTAB
Time Frame
Week 0, 6 and 12
Title
Change in spatial memory
Description
Assessed using Spatial Working Memory (SWM) task from CANTAB
Time Frame
Week 0, 6 and 12
Title
Change in verbal memory
Description
Assessed using Verbal Recognition Memory (VRM) task from CANTAB
Time Frame
Week 0, 6 and 12
Title
Change in social cognition
Description
Assessed using Emotional Recognition task (ERT) from CANTAB
Time Frame
Week 0, 6 and 12
Title
Change in peripheral insulin resistance (IR)
Description
Measured by Matsuda's sensitivity index
Time Frame
Week 0, 6 and 12
Title
Change in hepatic insulin resistance (IR)
Description
Measured by homeostasis model assessment (HOMA)
Time Frame
Week 0, 6 and 12
Title
Change in salivary cortisol in response to glucose tolerance test
Description
Salivary cortisol measured by enzyme-linked immunoassay in nmol/liter
Time Frame
prior to and 120 minutes after glucose tolerance test
Title
Change in salivary cortisol in response to stress
Description
Salivary cortisol measured by enzyme-linked immunoassay in nmol/liter
Time Frame
prior to and 30, 60, 90 and 120 minutes after challenging task
Title
Change in body weight
Description
Measured in kg
Time Frame
Week 0, 6 and 12
Title
Change in waist circumference
Description
Measured in cm
Time Frame
Week 0, 6 and 12
Title
Change in activity level
Description
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
Title
Change in mitochondrial respiration
Description
Cellular bioenergetics measured as oxygen consumption rate (OCR)
Time Frame
Week 0, 6 and 12
Title
Change in cardiovascular related biomarkers
Description
Quantitative immunoassay of human cardiovascular biomarkers on a multi-analyte profile
Time Frame
Week 0, 6 and 12
Title
Change in inflammation related biomarkers
Description
Quantitative immunoassay of human inflammation biomarkers on a multi-analyte profile
Time Frame
Week 0, 6 and 12
Title
Change in neurological related biomarkers
Description
Quantitative immunoassay of human neurological biomarkers on a multi-analyte profile
Time Frame
Week 0, 6 and 12
Title
Change in perceived stress
Description
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
Title
Change in chronic stress
Description
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
Title
Change in self-reported sleep quality
Description
Sleep quality assessed by self-report using the Pittsburgh Sleep Quality Index
Time Frame
Week 0, 6 and 12
Title
Change in mood
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen L Bonnel, PhD
Phone
530-752-4184
Email
ellen.bonnel@ars.usda.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin D Laugero, PhD
Phone
530-752-4173
Email
kevin.laugero@ars.usda.gov
Facility Information:
Facility Name
USDA, ARS, Western Human Nutrition Research Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen L Bonnel, PhD
Phone
530-752-4184
Email
ellen.bonnel@ars.usda.gov
First Name & Middle Initial & Last Name & Degree
Kevin Laugero, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cardiometabolic Effects of Sweet Cherry Juice
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