Tart Cherry Juice and Chronic Disease Risk

NCT03638362 | Completed

• 1 other identifier: 10015542
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

CVD; Diabetes; Inflammation

Keywords

obese; overweight; tart cherry juice

Outcome Measures

Primary Outcomes (1)

• TCJ and hsCRP

  high-sensitivity C-reactive protein (hsCRP), a marker of inflammation

  4 weeks

Secondary Outcomes (1)

• fasting triglycerides

  4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Tart cherry juice (TCJ)

EXPERIMENTAL

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.

Dietary Supplement: Tart cherry juice

Interventions

Placebo DIETARY_SUPPLEMENT

Participants consumed placebo beverage for 4 weeks.

Placebo

Tart cherry juice DIETARY_SUPPLEMENT

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

Tart cherry juice (TCJ)

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

MeSH Terms

Conditions

Diabetes Mellitus; Inflammation; Obesity; Overweight

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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 selected from commercially available, artificially flavored and colored fruit punches (Great Value fruit punch, Bentonville, AR) to match a closely as possible the color (red) of the TCJ.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: Crossover Assignment 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 10-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 authentic TCJ for 4 weeks, followed by a 2-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 inflammation, glycemia, and lipidemia.

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 20, 2018
• Study Start: August 21, 2009
• Primary Completion: September 30, 2011
• Study Completion: September 30, 2011
• Last Updated: August 20, 2018

Record last verified: 2018-08

Data Sharing

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