HyperuricemiaNCT03636529
Tart Cherry Juice and Markers of Inflammation, CVD, and Diabetes
A study testing Tart cherry juice in people with Hyperuricemia and Insulin Resistance, run by University of Memphis.
Trial summary
In this study, the investigators recruited at-risk individuals (n=26) who were overweight (25.0-29.9 kg/m2) and obese (> 30.0 kg/m2) and likely to exhibit one or more conditions associated with Metabolic Syndrome (MetS). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia, Insulin Resistance, Obesity
- What is being tested?
- Tart cherry juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2010to 31 May 2011
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- This study was a 12-week 2 x 2 crossover, randomized, placebo-controlled dietary intervention in overweight and obese participants (BMI>25.0 kg/m2) who are more likely to exhibit >1 of the 5 risk conditions associated with metabolic syndrome (MetS). BMI was the minimal criterion for recruitment.
Who cannot join
- Participants were >18 years of age, not pregnant, not diabetic, with no unresolved infections or diseases (diabetes, CVD, IBD, cancer and liver disease), and nonsmokers. Histories of medication and dietary supplement use were collected and those taking anti-inflammatory or lipid-lowering medications were excluded.
About this study
Official title: Anthocyanin-rich Tart Cherry Juice Consumption and Reduced Biomarkers of Inflammation, CVD, and Diabetes.
In this study, the investigators recruited at-risk individuals (n=26) who were overweight (25.0-29.9 kg/m2) and obese (> 30.0 kg/m2) and likely to exhibit one or more conditions associated with Metabolic Syndrome (MetS). In this 12-week placebo-controlled 2 x 2 crossover dietary intervention, the investigators randomized participants to consume 240 mL (8 ounces) daily of either placebo (artificial cherry-flavored, anthocyanin-free beverage) or TCJ for 4 weeks, followed by a 4-week washout period, then consumption of the alternate beverage for 4 weeks. Subsequently, the investigators determined the effect of TCJ in at-risk participants on markers of uricemia, lipidemia, glycemia, and inflammation.
Read the detailed description
In this study, the investigators recruited at-risk individuals (n=26) who were overweight (25.0-29.9 kg/m2) and obese (> 30.0 kg/m2) and likely to exhibit one or more conditions associated with MetS. Participants were >18 years of age, not pregnant, not diabetic, with no unresolved infections or diseases (diabetes, CVD, IBD, cancer and liver disease), and nonsmokers. Histories of medication and dietary supplement use were collected and those taking anti-inflammatory or lipid-lowering medications were excluded. After enrollment, participants were randomly assigned to consume daily either 240 mL (8 ounces) of TCJ diluted (1:6 v/v) from concentrate (Coloma Frozen Foods, Coloma, MI ) or a placebo beverage for 4 weeks. The placebo was prepared by combining 48.3 g each of dextrose and fructose (Batory Foods, Des Plaines, IL), food-grade red and blue dyes (2.0 mL and 0.1 mL, respectively; McCormick \& Company, Inc., Sparks, MD), lemon powder drink mix (0.8 g; True Citrus, Baltimore, MD), powdered black cherry drink mix (4.0 g; Kraft Foods Group, Inc., Northfield, IL), and filtered, bottled water (local supermarket) to produce 1 liter of placebo beverage. After a 4-week washout period, participants consumed the alternate beverage for 4 weeks in this 12-week 2x2 crossover, placebo-controlled dietary intervention. Subsequently, the investigators determined the effect of TCJ in at-risk participants on markers of uricemia (sUA), lipidemia (HDL, LDL, triglycerides, VLDL, total cholesterol), glycemia (fasting insulin and glucose, HOMA, QUICKI, McAuley indirect indices), and inflammation (hsCRP, TNF-alpha, and ESR).
- Conditions
- Hyperuricemia, Insulin Resistance, Obesity, CVD
- Being tested
- Tart cherry juice, Placebo
- Keywords
- obese, overweight, tart cherry juice
- Medical subject headings
- Hyperuricemia, Insulin Resistance, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tart cherry juiceDietary supplement
Participants randomized to consume for 4-weeks either placebo beverage or single-strength tart cherry juice at beginning of the study followed by a 4 week washout then switch over to the alternate beverage for 4 weeks to account for timing and order effects.
PlaceboOther
Participants randomized to consume either placebo beverage or tart cherry juice at beginning of the study followed by a 4 week washout then switch over to the alternate beverage to account for timing and order effects.
| Study group | Role | What they receive |
|---|---|---|
| Tart cherry juice (TCJ) | Active comparator | Participants randomized to consume either placebo beverage or tart cherry juice at beginning of the study followed by a 4 week washout then switch over to the alternate beverage to account for timing and order effects. Receives: Dietary Supplement: Tart cherry juice |
| Placebo | Placebo comparator | Participants randomized to consume either placebo beverage or tart cherry juice at beginning of the study followed by a 4 week washout then switch over to the alternate beverage to account for timing and order effects. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum uric acid
Hyperuricemia contributes to gout, a frequently occurring, complex rheumatologic form of inflammatory arthritis. The primary outcome measure of this study was serum uric acid and its reduction by TCJ consumption.
Measured: 4 weeks
Secondary outcomes (2)
High sensitivity C-reactive protein (hsCRP)
Elevated levels of hsCRP indicate inflammation. Serum levels of hsCRP as a secondary outcome measure were measured and the effect of TCJ in potentially lowering.
Measured: 4 weeks
Serum triglycerides
Increased serum triglycerides contribute to CVD and MetS. Serum TG was measured as a secondary outcome measure and the effect of TCJ in lowering levels.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Jun 2010
- Primary completion31 May 2011
- Study completion31 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperuricemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In this study, the investigators recruited at-risk individuals who were overweight (25.0-29.9 kg/m2) and obese (\> 30.0 kg/m2) and likely to exhibit one or more conditions associated with MetS. In this 12-week placebo-controlled 2 x 2 crossover dietary intervention, the investigators randomized participants to consume 240 mL (8 ounces) daily of either placebo (artificial cherry-flavored, anthocyanin-free beverage) or TCJ for 4 weeks, followed by a 4-week washout period, then consumption of the alternate beverage for 4 weeks. Subsequently, the investigators determined the effect of TCJ in at-risk participants on markers of uricemia, lipidemia, glycemia, and inflammation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Principal investigator, Keith Martin, University of Memphis
- Investigators
- Keith R Martin, PhD, MTox, Principal investigator, Principal Investigator, School of Health Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636529
- Sponsor's protocol ID
- 0902003690
- Status last verified
- Aug 2018
- First submitted
- 14 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Coded data will be available upon reasonable request as instructed by journal editors. Emails may be directed to the Principal Investigator.
Publications
Martin KR, Coles KM. Consumption of 100% Tart Cherry Juice Reduces Serum Urate in Overweight and Obese Adults. Curr Dev Nutr. 2019 Feb 25;3(5):nzz011. doi: 10.1093/cdn/nzz011. eCollection 2019 May.
PubMed 31037275
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anthocyanin-rich Tart Cherry Juice Consumption and Reduced Biomarkers of Inflammation, CVD, and Diabetes.
- ClinicalTrials.gov ID
- NCT03636529
- Acronym / sponsor ID
- 0902003690
- Conditions
- Hyperuricemia, Insulin Resistance, Obesity, CVD
- Keywords
- obese, overweight, tart cherry juice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- 1 Jun 2010 (actual)
- Primary completion
- 31 May 2011 (actual)
- Study completion
- 31 May 2011 (actual)
- First posted
- 17 Aug 2018 (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.
In this study, the investigators recruited at-risk individuals (n=26) who were overweight (25.0-29.9 kg/m2) and obese (> 30.0 kg/m2) and likely to exhibit one or more conditions associated with Metabolic Syndrome (MetS). In this 12-week placebo-controlled 2 x 2 crossover dietary intervention, the investigators randomized participants to consume 240 mL (8 ounces) daily of either placebo (artificial cherry-flavored, anthocyanin-free beverage) or TCJ for 4 weeks, followed by a 4-week washout period, then consumption of the alternate beverage for 4 weeks. Subsequently, the investigators determined the effect of TCJ in at-risk participants on markers of uricemia, lipidemia, glycemia, and inflammation.
Detailed description
In this study, the investigators recruited at-risk individuals (n=26) who were overweight (25.0-29.9 kg/m2) and obese (> 30.0 kg/m2) and likely to exhibit one or more conditions associated with MetS. Participants were >18 years of age, not pregnant, not diabetic, with no unresolved infections or diseases (diabetes, CVD, IBD, cancer and liver disease), and nonsmokers. Histories of medication and dietary supplement use were collected and those taking anti-inflammatory or lipid-lowering medications were excluded. After enrollment, participants were randomly assigned to consume daily either 240 mL (8 ounces) of TCJ diluted (1:6 v/v) from concentrate (Coloma Frozen Foods, Coloma, MI ) or a placebo beverage for 4 weeks. The placebo was prepared by combining 48.3 g each of dextrose and fructose (Batory Foods, Des Plaines, IL), food-grade red and blue dyes (2.0 mL and 0.1 mL, respectively; McCormick \& Company, Inc., Sparks, MD), lemon powder drink mix (0.8 g; True Citrus, Baltimore, MD), powdered black cherry drink mix (4.0 g; Kraft Foods Group, Inc., Northfield, IL), and filtered, bottled water (local supermarket) to produce 1 liter of placebo beverage. After a 4-week washout period, participants consumed the alternate beverage for 4 weeks in this 12-week 2x2 crossover, placebo-controlled dietary intervention. Subsequently, the investigators determined the effect of TCJ in at-risk participants on markers of uricemia (sUA), lipidemia (HDL, LDL, triglycerides, VLDL, total cholesterol), glycemia (fasting insulin and glucose, HOMA, QUICKI, McAuley indirect indices), and inflammation (hsCRP, TNF-alpha, and ESR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In this study, the investigators recruited at-risk individuals who were overweight (25.0-29.9 kg/m2) and obese (> 30.0 kg/m2) and likely to exhibit one or more conditions associated with MetS. In this 12-week placebo-controlled 2 x 2 crossover dietary intervention, the investigators randomized participants to consume 240 mL (8 ounces) daily of either placebo (artificial cherry-flavored, anthocyanin-free beverage) or TCJ for 4 weeks, followed by a 4-week washout period, then consumption of the alternate beverage for 4 weeks. Subsequently, the investigators determined the effect of TCJ in at-risk participants on markers of uricemia, lipidemia, glycemia, and inflammation.
| Arm | Type | Receives |
|---|---|---|
| Tart cherry juice (TCJ) | Active comparator | Dietary Supplement: Tart cherry juiceParticipants randomized to consume either placebo beverage or tart cherry juice at beginning of the study followed by a 4 week washout then switch over to the alternate beverage to account for timing and order effects. |
| Placebo | Placebo comparator | Other: PlaceboParticipants randomized to consume either placebo beverage or tart cherry juice at beginning of the study followed by a 4 week washout then switch over to the alternate beverage to account for timing and order effects. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- This study was a 12-week 2 x 2 crossover, randomized, placebo-controlled dietary intervention in overweight and obese participants (BMI>25.0 kg/m2) who are more likely to exhibit >1 of the 5 risk conditions associated with metabolic syndrome (MetS). BMI was the minimal criterion for recruitment.
Key exclusion criteria (1 listed)
- Participants were >18 years of age, not pregnant, not diabetic, with no unresolved infections or diseases (diabetes, CVD, IBD, cancer and liver disease), and nonsmokers. Histories of medication and dietary supplement use were collected and those taking anti-inflammatory or lipid-lowering medications were excluded.
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 juiceParticipants randomized to consume for 4-weeks either placebo beverage or single-strength tart cherry juice at beginning of the study followed by a 4 week washout then switch over to the alternate beverage for 4 weeks to account for timing and order effects. | Dietary supplement | Tart cherry juice (TCJ) |
| PlaceboParticipants randomized to consume either placebo beverage or tart cherry juice at beginning of the study followed by a 4 week washout then switch over to the alternate beverage to account for timing and order effects. | Other | Placebo |
Primary outcome
serum uric acid
Time frame: 4 weeks
Hyperuricemia contributes to gout, a frequently occurring, complex rheumatologic form of inflammatory arthritis. The primary outcome measure of this study was serum uric acid and its reduction by TCJ consumption.
2 secondary outcomes
High sensitivity C-reactive protein (hsCRP)
Time frame: 4 weeks
Serum triglycerides
Time frame: 4 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 17 Aug 2018.
- Derived from this study: PubMed 31037275Martin KR, Coles KM. Consumption of 100% Tart Cherry Juice Reduces Serum Urate in Overweight and Obese Adults. Curr Dev Nutr. 2019 Feb 25;3(5):nzz011. doi: 10.1093/cdn/nzz011. eCollection 2019 May.
- Individual participant dataSharing planned: Yes. Coded data will be available upon reasonable request as instructed by journal editors. Emails may be directed to the Principal Investigator.
Related trials for Hyperuricemia
Active, not recruitingObservational study
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Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia
Chronic Kidney Disease
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A Study of Dotinurad Versus Allopurinol in Participants With Gout
Gout
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A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
Not yet recruitingPhase 3
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
Gout Disease
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.
Keith R Martin, PhD, MTox principal investigator
Principal Investigator, School of Health Studies
Questions about this trial
What is this clinical trial studying?
A study testing Tart cherry juice in people with Hyperuricemia and Insulin Resistance, run by University of Memphis.
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 1 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 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
serum uric acid (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03636529, which also lists 1 linked publication.
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 17 Aug 2018.