Role of Cherry Consumption in Reducing Risk Factors for Chronic Inflammatory Diseases

NCT ID: NCT01734070

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2004-09-30

Brief Summary

The goal of this study is to examine if chronic cherry consumption will decrease lipid peroxidation and serum concentration of inflammatory markers in human subjects with elevated serum C reactive protein (CRP), and to examine the relationship between serum concentrations of CRP and polyphenols. The investigators hypothesize that cherry consumption will reduce serum concentration of inflammatory markers, including CRP, inflammatory cytokines and adhesion molecules.

Detailed Description

The study will last a total of 64 days with three different metabolic periods. First 8 days will be period 1, when base line fasting blood samples will be collected on day 1 and 8. For the next 28 days (period 2 or intervention period) subjects will supplement their diets with 280 g/d of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories. We will prefer that the subjects split the cherries into three equal portions and consume one with each meal; however, this will not be mandatory. Subjects will be asked to record all foods and drinks consumed for three 24-hr periods during the study. Fasting blood samples will be drawn on study days 22 and 36 (14 and 28 day after the start of cherry consumption). The third period of 28 days will be post-intervention, when the subjects will return to their normal diets without cherries. Post-intervention blood samples will be drawn on study day 64. All blood draws will follow a 12-hour fast. Blood samples will be processed within one hour of draw and the plasma stored frozen in different aliquots, until analysis.

Conditions

Inflammation; Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cherry consumption

Volunteers will supplement their diets with 280 grams/day of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories. We will prefer that the subjects split the cherries into three equal portions and consume one with each meal; however, this will not be mandatory.

Group Type: EXPERIMENTAL

Cherry consumption

Intervention Type: OTHER

Volunteers will eat 280 grams/day of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories.

Interventions

Cherry consumption

Volunteers will eat 280 grams/day of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy men and women
• 45-65 years of age
• serum CRP concentrations between 3-25 mg/L
• BMI < 35 kg/m2

Exclusion Criteria

• BMI > 35 kg/m2
• current infection
• taking anti-inflammatory medications

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

California Cherry Board

OTHER

Sponsor Role: collaborator

USDA, Western Human Nutrition Research Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Darshan Kelley, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA, ARS, Western Human Nutrition Research Center

Locations

USDA, ARS, Western Human Nutrition Research Center

Davis, California, United States

Countries

United States

References

Kelley DS, Adkins Y, Reddy A, Woodhouse LR, Mackey BE, Erickson KL. Sweet bing cherries lower circulating concentrations of markers for chronic inflammatory diseases in healthy humans. J Nutr. 2013 Mar;143(3):340-4. doi: 10.3945/jn.112.171371. Epub 2013 Jan 23.

Reference Type: DERIVED

PMID: 23343675 (View on PubMed)

Related Links

http://www.ars.usda.gov/Main/docs.htm?docid=11240

USDA, ARS, WHNRC

Other Identifiers

FL40

Identifier Type: -

Identifier Source: org_study_id