USDA, ARS, Western Human Nutrition Research Center
Davis, California, 95616, United States
NCT Number: NCT03948061
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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Notify Me20 year–65 year
All sexes
Interventional
Not applicable
Davis, California, 95616, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
FruitSmart® Cherry Concentrate: Dark Sweet Cherry Juice Concentrate produced from dark sweet cherries to retain the characteristic color and flavor of the whole fruit.
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.
Time frame: Week 0, 6 and 12
Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg
Time frame: Week 0, 6 and 12
Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg
Time frame: Week 0, 6 and 12
Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg
Time frame: Week 0, 6 and 12
Heart rate variability (HRV) assessed using a mobile device via ECG in millivolts
Time frame: Week 0, 6 and 12
Assessed using impedance cardiography (ICG) and ECG
Time frame: Week 0, 6 and 12
Assessed using electrocardiogram (ECG)
Time frame: Week 0, 6 and 12
Peripheral arterial tone (PAT) determined using the EndoPAT expressed as the reactive hyperemia index (RHI)
Time frame: Week 0, 6 and 12
Liver stiffness assessed from the shear wave speed with pulse echo ultrasound using the Fibroscan®
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®
Time frame: Week 0, 6 and 12
Assessed using Cambridge Gambling Task (CGT), from Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: Week 0, 6 and 12
Assessed using Stop Signal Task (STT) from CANTAB
Time frame: Week 0, 6 and 12
Assessed using Multitasking Test (MTT) from CANTAB
Time frame: Week 0, 6 and 12
Assessed using Reaction Time (RTI) task from CANTAB
Time frame: Week 0, 6 and 12
Assessed using Spatial Working Memory (SWM) task from CANTAB
Time frame: Week 0, 6 and 12
Assessed using Verbal Recognition Memory (VRM) task from CANTAB
Time frame: Week 0, 6 and 12
Assessed using Emotional Recognition task (ERT) from CANTAB
Time frame: Week 0, 6 and 12
Measured by Matsuda's sensitivity index
Time frame: Week 0, 6 and 12
Measured by homeostasis model assessment (HOMA)
Time frame: prior to and 120 minutes after glucose tolerance test
Salivary cortisol measured by enzyme-linked immunoassay in nmol/liter
Time frame: prior to and 30, 60, 90 and 120 minutes after challenging task
Salivary cortisol measured by enzyme-linked immunoassay in nmol/liter
Time frame: Week 0, 6 and 12
Measured in kg
Time frame: Week 0, 6 and 12
Measured in cm
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.
Time frame: Week 0, 6 and 12
Cellular bioenergetics measured as oxygen consumption rate (OCR)
Time frame: Week 0, 6 and 12
Quantitative immunoassay of human cardiovascular biomarkers on a multi-analyte profile
Time frame: Week 0, 6 and 12
Quantitative immunoassay of human inflammation biomarkers on a multi-analyte profile
Time frame: Week 0, 6 and 12
Quantitative immunoassay of human neurological biomarkers on a multi-analyte profile
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.
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.
Time frame: Week 0, 6 and 12
Sleep quality assessed by self-report using the Pittsburgh Sleep Quality Index
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.
USDA, Western Human Nutrition Research Center
Fed
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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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