Hyperuricemia, Insulin Resistance, Obesity, CVD
Conditions
Keywords
obese, overweight, tart cherry juice
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).
Interventions
DIETARY_SUPPLEMENTTart 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.
OTHERPlacebo
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.
Sponsors
Arizona State University
University of Memphis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum uric acid | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High sensitivity C-reactive protein (hsCRP) | 4 weeks | 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 | 4 weeks | 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. |
Outcome results
None listed