Tart Cherry Juice and Chronic Disease Risk

NCT ID: NCT03638362

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-21
• Study Completion Date: 2011-09-30

Brief Summary

In this study, the investigators recruited at-risk individuals (n=10) 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 10-week placebo-controlled 2 x 2 crossover dietary intervention, the investigators randomized participants (n=10) to consume 240 mL (8 ounces) daily of either placebo (artificial cherry-flavored, anthocyanin-free beverage) or authentic TCJ for 4 weeks, followed by a 2-week washout period, then consumption of the alternate beverage for 4 weeks. In this study, the investigators determined the effect of TCJ in at-risk participants on markers of inflammation, glycemia, and lipidemia.

Detailed Description

In this study, the investigators recruited at-risk individuals (n=10) 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, subjects were randomly assigned to consume daily either 240 mL (8 ounces) of authentic TCJ (R.W. Knudsen, Chico, CA) or a placebo beverage (commercial fruit punch; Great Value, Bentonville, AR) for 4 weeks. After a 2-week washout period, participants consumed the alternate beverage for 4 weeks in this 10-week 2x2 crossover, placebo-controlled dietary intervention. Subsequently, the investigators determined the effect of TCJ in at-risk participants on markers of 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

CVD; Diabetes; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo

Participants randomized to consume either placebo beverage or tart cherry juice at beginning of the study followed by a 2 week washout then switch over to the alternate beverage. Approximately half of participants began study consuming placebo beverage and the other half TCJ.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Participants consumed placebo beverage for 4 weeks.

Tart cherry juice (TCJ)

Participants randomized to consume either placebo beverage or tart cherry juice at beginning of the study followed by a 2 week washout then switch over to the alternate beverage. Approximately half pf participants began study consuming placebo beverage and the other half TCJ.

Group Type: EXPERIMENTAL

Tart cherry juice

Intervention Type: DIETARY_SUPPLEMENT

Participants consumed tart cherry juice (8 ounces; 240 mL) per day for four weeks.

Interventions

Placebo

Participants consumed placebo beverage for 4 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Tart cherry juice

Participants consumed tart cherry juice (8 ounces; 240 mL) per day for four weeks.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arizona State University

OTHER

Sponsor Role: collaborator

University of Memphis

OTHER

Sponsor Role: lead

Responsible Party

Keith Martin

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keith R Martin, PhD, MTox

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator, School of Health Studies

Other Identifiers

10015542

Identifier Type: -

Identifier Source: org_study_id