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Cardiometabolic Effects of Sweet Cherry Juice

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ClinicalTrials.gov Identifier: NCT03948061
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Washington State Fruit Commission
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center

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.

Condition or disease Intervention/treatment Phase
Obesity Metabolic Syndrome Other: Cherry juice Other: Placebo beverage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Cardiometabolic Effects of Sweet Cherry Juice
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2022

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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Change in cardiac parasympathetic control [ Time Frame: Week 0, 6 and 12 ]
    Assessed using impedance cardiography (ICG) and ECG

  6. Change in electrical activity of heartbeat [ Time Frame: Week 0, 6 and 12 ]
    Assessed using electrocardiogram (ECG)


Secondary Outcome Measures :
  1. Change in vascular function [ Time Frame: Week 0, 6 and 12 ]
    Peripheral arterial tone (PAT) determined using the EndoPAT expressed as the reactive hyperemia index (RHI)

  2. Change in liver stiffness [ Time Frame: Week 0, 6 and 12 ]
    Liver stiffness assessed from the shear wave speed with pulse echo ultrasound using the Fibroscan®

  3. Change in liver fat [ Time Frame: Week 0, 6 and 12 ]
    Liver fat assessed from the Controlled Attenuation Parameter (CAP) computed from the liver stiffness measurement using the Fibroscan®

  4. Change in executive function [ Time Frame: Week 0, 6 and 12 ]
    Assessed using Cambridge Gambling Task (CGT), from Cambridge Neuropsychological Test Automated Battery (CANTAB)

  5. Change in attentive function [ Time Frame: Week 0, 6 and 12 ]
    Assessed using Stop Signal Task (STT) from CANTAB

  6. Change in multitasking [ Time Frame: Week 0, 6 and 12 ]
    Assessed using Multitasking Test (MTT) from CANTAB

  7. Change in psycho-motor speed [ Time Frame: Week 0, 6 and 12 ]
    Assessed using Reaction Time (RTI) task from CANTAB

  8. Change in spatial memory [ Time Frame: Week 0, 6 and 12 ]
    Assessed using Spatial Working Memory (SWM) task from CANTAB

  9. Change in verbal memory [ Time Frame: Week 0, 6 and 12 ]
    Assessed using Verbal Recognition Memory (VRM) task from CANTAB

  10. Change in social cognition [ Time Frame: Week 0, 6 and 12 ]
    Assessed using Emotional Recognition task (ERT) from CANTAB

  11. Change in peripheral insulin resistance (IR) [ Time Frame: Week 0, 6 and 12 ]
    Measured by Matsuda's sensitivity index

  12. Change in hepatic insulin resistance (IR) [ Time Frame: Week 0, 6 and 12 ]
    Measured by homeostasis model assessment (HOMA)

  13. Change in salivary cortisol in response to glucose tolerance test [ Time Frame: prior to and 120 minutes after glucose tolerance test ]
    Salivary cortisol measured by enzyme-linked immunoassay in nmol/liter

  14. Change in salivary cortisol in response to stress [ Time Frame: prior to and 30, 60, 90 and 120 minutes after challenging task ]
    Salivary cortisol measured by enzyme-linked immunoassay in nmol/liter

  15. Change in body weight [ Time Frame: Week 0, 6 and 12 ]
    Measured in kg

  16. Change in waist circumference [ Time Frame: Week 0, 6 and 12 ]
    Measured in cm

  17. Change in activity level [ Time Frame: Week 0, 6 and 12 ]
    Measured by Stanford Brief Physical Activity questionnaire. Scale is categorical for two subscales: work physical activity and leisure time activity.

  18. Change in mitochondrial respiration [ Time Frame: Week 0, 6 and 12 ]
    Cellular bioenergetics measured as oxygen consumption rate (OCR)

  19. Change in cardiovascular related biomarkers [ Time Frame: Week 0, 6 and 12 ]
    Quantitative immunoassay of human cardiovascular biomarkers on a multi-analyte profile

  20. Change in inflammation related biomarkers [ Time Frame: Week 0, 6 and 12 ]
    Quantitative immunoassay of human inflammation biomarkers on a multi-analyte profile

  21. Change in neurological related biomarkers [ Time Frame: Week 0, 6 and 12 ]
    Quantitative immunoassay of human neurological biomarkers on a multi-analyte profile

  22. Change in perceived stress [ Time Frame: Week 0, 6 and 12 ]
    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.

  23. Change in chronic stress [ Time Frame: Week 0, 6 and 12 ]
    Chronic stress measured using the Wheaton Chronic Stress Questionnaire. Individual scores range from 0 to 102, with higher scores indicating higher chronic stress.

  24. Change in self-reported sleep quality [ Time Frame: Week 0, 6 and 12 ]
    Sleep quality assessed by self-report using the Pittsburgh Sleep Quality Index

  25. Change in mood [ Time Frame: Week 0, 6 and 12 ]
    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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948061


Contacts
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Contact: Ellen L Bonnel, PhD 530-752-4184 ellen.bonnel@ars.usda.gov
Contact: Kevin D Laugero, PhD 530-752-4173 kevin.laugero@ars.usda.gov

Locations
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United States, California
USDA, ARS, Western Human Nutrition Research Center Recruiting
Davis, California, United States, 95616
Contact: Ellen L Bonnel, PhD    530-752-4184    ellen.bonnel@ars.usda.gov   
Principal Investigator: Kevin Laugero, PhD         
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
Washington State Fruit Commission
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Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT03948061    
Other Study ID Numbers: FL108
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by USDA, Western Human Nutrition Research Center:
cherries
inflammatory disease
chronic stress
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases