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出境医 / 临床实验 / Cardiometabolic Effects of Sweet Cherry Juice
Cardiometabolic Effects of Sweet Cherry Juice
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.
| 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.
Study Design
| 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, 2022 |
| Estimated Study Completion Date : | May 31, 2022 |
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures :
- 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
- 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
- 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
- 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
- Change in cardiac parasympathetic control [ Time Frame: Week 0, 6 and 12 ]Assessed using impedance cardiography (ICG) and ECG
- Change in electrical activity of heartbeat [ Time Frame: Week 0, 6 and 12 ]Assessed using electrocardiogram (ECG)
Secondary Outcome Measures :
- 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)
- 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®
- 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®
- Change in executive function [ Time Frame: Week 0, 6 and 12 ]Assessed using Cambridge Gambling Task (CGT), from Cambridge Neuropsychological Test Automated Battery (CANTAB)
- Change in attentive function [ Time Frame: Week 0, 6 and 12 ]Assessed using Stop Signal Task (STT) from CANTAB
- Change in multitasking [ Time Frame: Week 0, 6 and 12 ]Assessed using Multitasking Test (MTT) from CANTAB
- Change in psycho-motor speed [ Time Frame: Week 0, 6 and 12 ]Assessed using Reaction Time (RTI) task from CANTAB
- Change in spatial memory [ Time Frame: Week 0, 6 and 12 ]Assessed using Spatial Working Memory (SWM) task from CANTAB
- Change in verbal memory [ Time Frame: Week 0, 6 and 12 ]Assessed using Verbal Recognition Memory (VRM) task from CANTAB
- Change in social cognition [ Time Frame: Week 0, 6 and 12 ]Assessed using Emotional Recognition task (ERT) from CANTAB
- Change in peripheral insulin resistance (IR) [ Time Frame: Week 0, 6 and 12 ]Measured by Matsuda's sensitivity index
- Change in hepatic insulin resistance (IR) [ Time Frame: Week 0, 6 and 12 ]Measured by homeostasis model assessment (HOMA)
- 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
- 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
- Change in body weight [ Time Frame: Week 0, 6 and 12 ]Measured in kg
- Change in waist circumference [ Time Frame: Week 0, 6 and 12 ]Measured in cm
- 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.
- Change in mitochondrial respiration [ Time Frame: Week 0, 6 and 12 ]Cellular bioenergetics measured as oxygen consumption rate (OCR)
- Change in cardiovascular related biomarkers [ Time Frame: Week 0, 6 and 12 ]Quantitative immunoassay of human cardiovascular biomarkers on a multi-analyte profile
- Change in inflammation related biomarkers [ Time Frame: Week 0, 6 and 12 ]Quantitative immunoassay of human inflammation biomarkers on a multi-analyte profile
- Change in neurological related biomarkers [ Time Frame: Week 0, 6 and 12 ]Quantitative immunoassay of human neurological biomarkers on a multi-analyte profile
- 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.
- 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.
- 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
- 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.
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| 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
| 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
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 25, 2019 | ||||||||
| First Posted Date ICMJE | May 13, 2019 | ||||||||
| Last Update Posted Date | November 3, 2020 | ||||||||
| Actual Study Start Date ICMJE | October 1, 2019 | ||||||||
| Estimated Primary Completion Date | May 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Cardiometabolic Effects of Sweet Cherry Juice | ||||||||
| Official Title ICMJE | Cardiometabolic Effects of Sweet Cherry Juice | ||||||||
| 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. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Basic Science |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
36 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | May 31, 2022 | ||||||||
| Estimated Primary Completion Date | May 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years to 65 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03948061 | ||||||||
| Other Study ID Numbers ICMJE | FL108 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | USDA, Western Human Nutrition Research Center | ||||||||
| Study Sponsor ICMJE | USDA, Western Human Nutrition Research Center | ||||||||
| Collaborators ICMJE | Washington State Fruit Commission | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | USDA, Western Human Nutrition Research Center | ||||||||
| Verification Date | November 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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