Tart Cherry Juice and Markers of Inflammation, CVD, and Diabetes

NCT03636529 | Completed

• 1 other identifier: 0902003690
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperuricemia; Insulin Resistance; Obesity; CVD

Keywords

obese; overweight; tart cherry juice

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (2)

• High sensitivity C-reactive protein (hsCRP)

  4 weeks

• Serum triglycerides

  4 weeks

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Tart cherry juice DIETARY_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.

Tart cherry juice (TCJ)

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Memphis: lead
• Arizona State University: collaborator

Related Publications (1)

• 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.

  PMID: 31037275 DERIVED

MeSH Terms

Conditions

Hyperuricemia; Insulin Resistance; Obesity; Overweight

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Study Officials

• Keith R Martin, PhD, MTox

  Principal Investigator, School of Health Studies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 17, 2018
• Study Start: June 1, 2010
• Primary Completion: May 31, 2011
• Study Completion: May 31, 2011
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL