Cardiovascular Risk FactorsNCT02922920
Effects of Tart Cherry Juice on the Body
A study testing Tart cherry juice in people with Cardiovascular Risk Factors and Age-Related Cognitive Decline, run by University of Delaware at 1 site in United States.
Trial summary
Tart cherries are a rich source of antioxidants. Studies have shown that tart cherries exert anti-oxidative and anti-inflammatory properties. The purpose of this study is to learn about the effects of drinking tart cherry juice on cardiovascular and cognitive health. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors, Age-Related Cognitive Decline
- What is being tested?
- Tart cherry juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Sep 2016
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65-80
Who cannot join
- Allergic to tart cherries
- Heavy smoker
- Taking medications that affect cognitive function
- History of neurological disorders
- History of traumatic brain injury
- History of stroke
Show all 12Show fewer
- Clinical diagnosis of diabetes
- Clinical diagnosis of Alzheimer's Disease/Dementia
- GI disease
- Kidney disease
- Liver disease
- Cancer
Trial locations and contacts
1 site in 1 country.
About this study
Tart cherries are a rich source of antioxidants. Studies have shown that tart cherries exert anti-oxidative and anti-inflammatory properties. The purpose of this study is to learn about the effects of drinking tart cherry juice on cardiovascular and cognitive health.
Read the detailed description
Thirty-seven older adults were randomly assigned to drink 16 oz per day of either tart cherry juice or placebo drink for 12 weeks. Blood and urine samples were collected at baseline and 12 weeks to assess biomarkers. Physical activity and 3-day diet records were also collected throughout the study.
- Being tested
- Tart cherry juice, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tart cherry juiceOther
16 fl. oz of tart cherry juice
PlaceboOther
16 fl. oz of placebo
| Study group | Role | What they receive |
|---|---|---|
| Tart cherry juice | Experimental | Participants consumed 16 fl. oz of tart cherry juice daily for 12 weeks. Receives: Other: Tart cherry juice |
| Placebo juice | Placebo comparator | Participants consumed 16 fl. oz of placebo daily for 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Change from baseline in cognitive test performance at 12 weeks
Measured: Baseline and 12 weeks
Secondary outcomes (3)
Cardiovascular risk factors
Fasting blood samples were collected at baseline and 12 weeks. Change from baseline in cardiovascular risk factors including blood lipid profiles, atherogenic risk ratios, blood glucose, hemoglobin A1c, insulin, and blood pressure at 12 weeks.
Measured: Baseline and 12 weeks
Oxidative stress markers
Fasting blood samples were collected at baseline and 12 weeks. Change from baseline in plasma 8-oxoguanine (ng/ml), plasma 8-hydroxy-2deoxy-guanosine (ng/mL), plasma hydroxynonenal (ng/ml), and plasma malondialdehyde (pmole/L) at 12 weeks.
Measured: Baseline and 12 weeks
Inflammatory markers
Fasting blood samples were collected at baseline and 12 weeks. Change from baseline in plasma tumor-necrosis factor-α (pg/mL) and plasma high-sensitivity C-reactive protein (ng/mL) at 12 weeks.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startNov 2014
- Primary completionMay 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheau Ching Chai, University of Delaware
- Investigators
- Sheau Ching Chai, PhD, RD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922920
- Sponsor's protocol ID
- 15A00149
- Status last verified
- Oct 2016
- First submitted
- 20 Sep 2016
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tart Cherry Juice on the Body
- ClinicalTrials.gov ID
- NCT02922920
- Acronym / sponsor ID
- 15A00149
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 4 Oct 2016 (estimated)
- 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.
Tart cherries are a rich source of antioxidants. Studies have shown that tart cherries exert anti-oxidative and anti-inflammatory properties. The purpose of this study is to learn about the effects of drinking tart cherry juice on cardiovascular and cognitive health.
Detailed description
Thirty-seven older adults were randomly assigned to drink 16 oz per day of either tart cherry juice or placebo drink for 12 weeks. Blood and urine samples were collected at baseline and 12 weeks to assess biomarkers. Physical activity and 3-day diet records were also collected throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tart cherry juice | Experimental | Other: Tart cherry juiceParticipants consumed 16 fl. oz of tart cherry juice daily for 12 weeks. |
| Placebo juice | Placebo comparator | Other: PlaceboParticipants consumed 16 fl. oz of placebo daily for 12 weeks. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age 65-80
Key exclusion criteria (12 listed)
- Allergic to tart cherries
- Heavy smoker
- Taking medications that affect cognitive function
- History of neurological disorders
- History of traumatic brain injury
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 |
|---|---|---|
| Tart cherry juice16 fl. oz of tart cherry juice | Other | Tart cherry juice |
| Placebo16 fl. oz of placebo | Other | Placebo juice |
Primary outcome
Cognitive function
Time frame: Baseline and 12 weeks
Change from baseline in cognitive test performance at 12 weeks
3 secondary outcomes
Cardiovascular risk factors
Time frame: Baseline and 12 weeks
Oxidative stress markers
Time frame: Baseline and 12 weeks
Inflammatory markers
Time frame: Baseline and 12 weeks
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 4 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Risk Factors
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)
Heart Failure, Cardiovascular Risk Factors
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.
Sheau Ching Chai, PhD, RD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tart cherry juice in people with Cardiovascular Risk Factors and Age-Related Cognitive Decline, run by University of Delaware 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 1 inclusion and 12 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 4 Oct 2016. 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. Some participants in this study may receive a placebo. 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?
Cognitive function (time frame: Baseline and 12 weeks). 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 4 Oct 2016.