NCT03636529

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

Anthocyanin-rich Tart Cherry Juice Consumption and Reduced Biomarkers of Inflammation, CVD, and Diabetes.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Memphis · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Hyperuricemia
• Insulin Resistance
• Obesity
• CVD

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Tart cherry juice	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.
OTHER	Placebo	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.

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-05-31
• Completion: 2011-05-31
• First posted: 2018-08-17
• Last updated: 2018-08-17