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

This study has been completed.
Sponsor:
Collaborator:
California Cherry Board
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01734070
First received: November 20, 2012
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Inflammation
Cardiovascular Diseases
Other: Cherry consumption

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Role of Cherry Consumption in Reducing Risk Factors for Human Chronic Inflammatory Diseases

Further study details as provided by USDA, Western Human Nutrition Research Center:

Primary Outcome Measures:
  • Change in lipid peroxidation [ Time Frame: baseline, day 36, and day 64 ] [ Designated as safety issue: No ]
    The study will last a total of 64 days with three different metabolic periods. First 8 days will be period 1, when baseline 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. Fasting blood samples will be drawn on study day 36. 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.


Secondary Outcome Measures:
  • Change in serum concentration of inflammatory markers [ Time Frame: baseline, day 36 and day 64 ] [ Designated as safety issue: No ]
    The study will last a total of 64 days with three different metabolic periods. First 8 days will be period 1, when baseline 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. Fasting blood samples will be drawn on study day 36. 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.


Enrollment: 20
Study Start Date: May 2003
Study Completion Date: September 2004
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: Cherry consumption
Volunteers will eat 280 grams/day of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories.

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.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734070

Locations
United States, California
USDA, ARS, Western Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
California Cherry Board
Investigators
Principal Investigator: Darshan Kelley, PhD USDA, ARS, Western Human Nutrition Research Center
  More Information

Additional Information:
No publications provided by USDA, Western Human Nutrition Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01734070     History of Changes
Other Study ID Numbers: FL40
Study First Received: November 20, 2012
Last Updated: February 7, 2013
Health Authority: United States: Federal Government

Keywords provided by USDA, Western Human Nutrition Research Center:
anthocyanins
catechins
chlorogenic acid
flavanol glycosides

Additional relevant MeSH terms:
Cardiovascular Diseases
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014