Cardiometabolic Effects of Sweet Cherry Juice

Obesity Clinical Trial

Official title:

Cardiometabolic Effects of Sweet Cherry Juice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03948061
• Other study ID #: FL108
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: October 25, 2023

Study information

• Verified date: October 2023
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 25, 2023
• Est. primary completion date: October 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	USDA, ARS, Western Human Nutrition Research Center	Davis	California

Sponsors (2)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center	Washington State Fruit Commission

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systolic blood pressure	Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg	Week 0, 6 and 12
Primary	Change in diastolic blood pressure	Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg	Week 0, 6 and 12
Primary	Change in mean arterial blood pressure	Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg	Week 0, 6 and 12
Primary	Change in heart rate variability	Heart rate variability (HRV) assessed using a mobile device via ECG in millivolts	Week 0, 6 and 12
Primary	Change in cardiac parasympathetic control	Assessed using impedance cardiography (ICG) and ECG	Week 0, 6 and 12
Primary	Change in electrical activity of heartbeat	Assessed using electrocardiogram (ECG)	Week 0, 6 and 12
Secondary	Change in vascular function	Peripheral arterial tone (PAT) determined using the EndoPAT expressed as the reactive hyperemia index (RHI)	Week 0, 6 and 12
Secondary	Change in liver stiffness	Liver stiffness assessed from the shear wave speed with pulse echo ultrasound using the Fibroscan®	Week 0, 6 and 12
Secondary	Change in liver fat	Liver fat assessed from the Controlled Attenuation Parameter (CAP) computed from the liver stiffness measurement using the Fibroscan®	Week 0, 6 and 12
Secondary	Change in executive function	Assessed using Cambridge Gambling Task (CGT), from Cambridge Neuropsychological Test Automated Battery (CANTAB)	Week 0, 6 and 12
Secondary	Change in attentive function	Assessed using Stop Signal Task (STT) from CANTAB	Week 0, 6 and 12
Secondary	Change in multitasking	Assessed using Multitasking Test (MTT) from CANTAB	Week 0, 6 and 12
Secondary	Change in psycho-motor speed	Assessed using Reaction Time (RTI) task from CANTAB	Week 0, 6 and 12
Secondary	Change in spatial memory	Assessed using Spatial Working Memory (SWM) task from CANTAB	Week 0, 6 and 12
Secondary	Change in verbal memory	Assessed using Verbal Recognition Memory (VRM) task from CANTAB	Week 0, 6 and 12
Secondary	Change in social cognition	Assessed using Emotional Recognition task (ERT) from CANTAB	Week 0, 6 and 12
Secondary	Change in peripheral insulin resistance (IR)	Measured by Matsuda's sensitivity index	Week 0, 6 and 12
Secondary	Change in hepatic insulin resistance (IR)	Measured by homeostasis model assessment (HOMA)	Week 0, 6 and 12
Secondary	Change in salivary cortisol in response to glucose tolerance test	Salivary cortisol measured by enzyme-linked immunoassay in nmol/liter	prior to and 120 minutes after glucose tolerance test
Secondary	Change in salivary cortisol in response to stress	Salivary cortisol measured by enzyme-linked immunoassay in nmol/liter	prior to and 30, 60, 90 and 120 minutes after challenging task
Secondary	Change in body weight	Measured in kg	Week 0, 6 and 12
Secondary	Change in waist circumference	Measured in cm	Week 0, 6 and 12
Secondary	Change in activity level	Measured by Stanford Brief Physical Activity questionnaire. Scale is categorical for two subscales: work physical activity and leisure time activity.	Week 0, 6 and 12
Secondary	Change in mitochondrial respiration	Cellular bioenergetics measured as oxygen consumption rate (OCR)	Week 0, 6 and 12
Secondary	Change in cardiovascular related biomarkers	Quantitative immunoassay of human cardiovascular biomarkers on a multi-analyte profile	Week 0, 6 and 12
Secondary	Change in inflammation related biomarkers	Quantitative immunoassay of human inflammation biomarkers on a multi-analyte profile	Week 0, 6 and 12
Secondary	Change in neurological related biomarkers	Quantitative immunoassay of human neurological biomarkers on a multi-analyte profile	Week 0, 6 and 12
Secondary	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.	Week 0, 6 and 12
Secondary	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.	Week 0, 6 and 12
Secondary	Change in self-reported sleep quality	Sleep quality assessed by self-report using the Pittsburgh Sleep Quality Index	Week 0, 6 and 12
Secondary	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.	Week 0, 6 and 12