Tart Cherry Juice and Markers of Inflammation, CVD, and Diabetes
Primary Purpose
Hyperuricemia, Insulin Resistance, Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tart cherry juice
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperuricemia focused on measuring obese, overweight, tart cherry juice
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Tart cherry juice (TCJ)
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03636529
First Posted
August 14, 2018
Last Updated
August 15, 2018
Sponsor
University of Memphis
Collaborators
Arizona State University
1. Study Identification
Unique Protocol Identification Number
NCT03636529
Brief Title
Tart Cherry Juice and Markers of Inflammation, CVD, and Diabetes
Official Title
Anthocyanin-rich Tart Cherry Juice Consumption and Reduced Biomarkers of Inflammation, CVD, and Diabetes.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2010 (Actual)
Primary Completion Date
May 31, 2011 (Actual)
Study Completion Date
May 31, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Memphis
Collaborators
Arizona State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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). 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia, Insulin Resistance, Obesity, CVD
Keywords
obese, overweight, tart cherry juice
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Participant
Masking Description
Placebo beverage was prepared in the ASU metabolic kitchen and matched for fructose and total carbohydrate concentrations as well as being artificially colored to match tart cherry juice.
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tart cherry juice (TCJ)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Tart cherry juice
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
serum uric acid
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
High sensitivity C-reactive protein (hsCRP)
Description
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.
Time Frame
4 weeks
Title
Serum triglycerides
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith R Martin, PhD, MTox
Organizational Affiliation
Principal Investigator, School of Health Studies
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Coded data will be available upon reasonable request as instructed by journal editors. Emails may be directed to the Principal Investigator.
Citations:
PubMed Identifier
31037275
Citation
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.
Results Reference
derived
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Tart Cherry Juice and Markers of Inflammation, CVD, and Diabetes
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