ObesityNCT03948061
Cardiometabolic Effects of Sweet Cherry Juice
A study testing Cherry juice in people with Obesity and Metabolic Syndrome, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome
- What is being tested?
- Cherry juice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 25 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosed metabolic disorder
- Diabetes mellitus
- Thyroid disease
- Cardiovascular disease
- Poly-cystic ovary syndrome
- Vasoconstrictive diseases (e.g. Raynaud's phenomenon or Raynaud's disease)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA, ARS, Western Human Nutrition Research Center
Davis, California, 95616
About this study
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.
Read the 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.
- Conditions
- Obesity, Metabolic Syndrome
- Being tested
- Cherry juice, Placebo beverage
- Keywords
- cherries, inflammatory disease, chronic stress
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cherry juiceOther
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 beverageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cherry juice followed by placebo | Experimental | Sweet cherry juice concentrate will be consumed twice daily for 6 weeks, followed by consumption of placebo beverage twice daily for 6 weeks. Receives: Other: Cherry juice; Other: Placebo beverage |
| Placebo beverage followed by cherry juice | Experimental | Placebo beverage will be consumed twice daily for 6 weeks, followed by consumption of sweet cherry juice concentrate twice daily for 6 weeks. Receives: Other: Cherry juice; Other: Placebo beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure
Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg
Measured: Week 0, 6 and 12
Change in diastolic blood pressure
Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg
Measured: Week 0, 6 and 12
Change in mean arterial blood pressure
Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg
Measured: Week 0, 6 and 12
Change in heart rate variability
Heart rate variability (HRV) assessed using a mobile device via ECG in millivolts
Measured: Week 0, 6 and 12
Change in cardiac parasympathetic control
Assessed using impedance cardiography (ICG) and ECG
Measured: Week 0, 6 and 12
Change in electrical activity of heartbeat
Assessed using electrocardiogram (ECG)
Measured: Week 0, 6 and 12
Secondary outcomes (25)
Change in vascular function
Peripheral arterial tone (PAT) determined using the EndoPAT expressed as the reactive hyperemia index (RHI)
Measured: Week 0, 6 and 12
Change in liver stiffness
Liver stiffness assessed from the shear wave speed with pulse echo ultrasound using the Fibroscan®
Measured: Week 0, 6 and 12
Change in liver fat
Liver fat assessed from the Controlled Attenuation Parameter (CAP) computed from the liver stiffness measurement using the Fibroscan®
Measured: Week 0, 6 and 12
Change in executive function
Assessed using Cambridge Gambling Task (CGT), from Cambridge Neuropsychological Test Automated Battery (CANTAB)
Measured: Week 0, 6 and 12
Change in attentive function
Assessed using Stop Signal Task (STT) from CANTAB
Measured: Week 0, 6 and 12
Change in multitasking
Assessed using Multitasking Test (MTT) from CANTAB
Measured: Week 0, 6 and 12
Change in psycho-motor speed
Assessed using Reaction Time (RTI) task from CANTAB
Measured: Week 0, 6 and 12
Change in spatial memory
Assessed using Spatial Working Memory (SWM) task from CANTAB
Measured: Week 0, 6 and 12
Change in verbal memory
Assessed using Verbal Recognition Memory (VRM) task from CANTAB
Measured: Week 0, 6 and 12
Change in social cognition
Assessed using Emotional Recognition task (ERT) from CANTAB
Measured: Week 0, 6 and 12
Change in peripheral insulin resistance (IR)
Measured by Matsuda's sensitivity index
Measured: Week 0, 6 and 12
Change in hepatic insulin resistance (IR)
Measured by homeostasis model assessment (HOMA)
Measured: Week 0, 6 and 12
Change in salivary cortisol in response to glucose tolerance test
Salivary cortisol measured by enzyme-linked immunoassay in nmol/liter
Measured: prior to and 120 minutes after glucose tolerance test
Change in salivary cortisol in response to stress
Salivary cortisol measured by enzyme-linked immunoassay in nmol/liter
Measured: prior to and 30, 60, 90 and 120 minutes after challenging task
Change in body weight
Measured in kg
Measured: Week 0, 6 and 12
Change in waist circumference
Measured in cm
Measured: Week 0, 6 and 12
Change in activity level
Measured by Stanford Brief Physical Activity questionnaire. Scale is categorical for two subscales: work physical activity and leisure time activity.
Measured: Week 0, 6 and 12
Change in mitochondrial respiration
Cellular bioenergetics measured as oxygen consumption rate (OCR)
Measured: Week 0, 6 and 12
Change in cardiovascular related biomarkers
Quantitative immunoassay of human cardiovascular biomarkers on a multi-analyte profile
Measured: Week 0, 6 and 12
Change in inflammation related biomarkers
Quantitative immunoassay of human inflammation biomarkers on a multi-analyte profile
Measured: Week 0, 6 and 12
Change in neurological related biomarkers
Quantitative immunoassay of human neurological biomarkers on a multi-analyte profile
Measured: Week 0, 6 and 12
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.
Measured: Week 0, 6 and 12
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.
Measured: Week 0, 6 and 12
Change in self-reported sleep quality
Sleep quality assessed by self-report using the Pittsburgh Sleep Quality Index
Measured: Week 0, 6 and 12
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.
Measured: Week 0, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start1 Oct 2019
- Primary completion25 Oct 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- Washington State Fruit Commission
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948061
- Sponsor's protocol ID
- FL108
- Status last verified
- Oct 2023
- First submitted
- 25 Apr 2019
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Effects of Sweet Cherry Juice
- ClinicalTrials.gov ID
- NCT03948061
- Acronym / sponsor ID
- FL108
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- cherries, inflammatory disease, chronic stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Collaborators
- Washington State Fruit Commission
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cherry juice followed by placebo | Experimental | Other: Cherry juice, Other: Placebo beverageSweet cherry juice concentrate will be consumed twice daily for 6 weeks, followed by consumption of placebo beverage twice daily for 6 weeks. |
| Placebo beverage followed by cherry juice | Experimental | Other: Cherry juice, Other: Placebo beveragePlacebo beverage will be consumed twice daily for 6 weeks, followed by consumption of sweet cherry juice concentrate twice daily for 6 weeks. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- Diagnosed metabolic disorder
- Diabetes mellitus
- Thyroid disease
- Cardiovascular disease
- Poly-cystic ovary syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cherry juiceFruitSmart® Cherry Concentrate: Dark Sweet Cherry Juice Concentrate produced from dark sweet cherries to retain the characteristic color and flavor of the whole fruit. | Other | Cherry juice followed by placebo, Placebo beverage followed by cherry juice |
| Placebo beverageCherry flavored placebo beverage prepared from commercially available cherry syrup with food coloring and thickener to match the color and viscosity of the cherry concentrate. | Other | Cherry juice followed by placebo, Placebo beverage followed by cherry juice |
Primary outcome
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)
25 secondary outcomes
Change in vascular function
Time frame: Week 0, 6 and 12
Change in liver stiffness
Time frame: Week 0, 6 and 12
Change in liver fat
Time frame: Week 0, 6 and 12
Change in executive function
Time frame: Week 0, 6 and 12
Change in attentive function
Time frame: Week 0, 6 and 12
Change in multitasking
Time frame: Week 0, 6 and 12
Change in psycho-motor speed
Time frame: Week 0, 6 and 12
Change in spatial memory
Time frame: Week 0, 6 and 12
Change in verbal memory
Time frame: Week 0, 6 and 12
Change in social cognition
Time frame: Week 0, 6 and 12
Change in peripheral insulin resistance (IR)
Time frame: Week 0, 6 and 12
Change in hepatic insulin resistance (IR)
Time frame: Week 0, 6 and 12
Change in salivary cortisol in response to glucose tolerance test
Time frame: prior to and 120 minutes after glucose tolerance test
Change in salivary cortisol in response to stress
Time frame: prior to and 30, 60, 90 and 120 minutes after challenging task
Change in body weight
Time frame: Week 0, 6 and 12
Change in waist circumference
Time frame: Week 0, 6 and 12
Change in activity level
Time frame: Week 0, 6 and 12
Change in mitochondrial respiration
Time frame: Week 0, 6 and 12
Change in cardiovascular related biomarkers
Time frame: Week 0, 6 and 12
Change in inflammation related biomarkers
Time frame: Week 0, 6 and 12
Change in neurological related biomarkers
Time frame: Week 0, 6 and 12
Change in perceived stress
Time frame: Week 0, 6 and 12
Change in chronic stress
Time frame: Week 0, 6 and 12
Change in self-reported sleep quality
Time frame: Week 0, 6 and 12
Change in mood
Time frame: Week 0, 6 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cherry juice in people with Obesity and Metabolic Syndrome, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure (time frame: Week 0, 6 and 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.