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Completed

NCT Number: NCT03948061

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cherry juice

Other

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 beverage

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Collaborators

  • Washington State Fruit Commission

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 13, 2019
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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