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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
University of Memphis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperuricemia focused on measuring obese, overweight, tart cherry juice

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 14, 2018
    Last Updated
    August 15, 2018
    Sponsor
    University of Memphis
    Collaborators
    Arizona State University
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    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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