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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03948061
Other study ID # FL108
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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