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

Primary Purpose

Inflammation, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cherry consumption
Sponsored by
USDA, Western Human Nutrition Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation focused on measuring anthocyanins, catechins, chlorogenic acid, flavanol glycosides

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • USDA, ARS, Western Human Nutrition Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cherry consumption

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in lipid peroxidation
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
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.

Full Information

First Posted
November 20, 2012
Last Updated
February 7, 2013
Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
California Cherry Board
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1. Study Identification

Unique Protocol Identification Number
NCT01734070
Brief Title
Role of Cherry Consumption in Reducing Risk Factors for Chronic Inflammatory Diseases
Official Title
Role of Cherry Consumption in Reducing Risk Factors for Human Chronic Inflammatory Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
California Cherry Board

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Cardiovascular Diseases
Keywords
anthocyanins, catechins, chlorogenic acid, flavanol glycosides

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cherry consumption
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cherry consumption
Intervention Description
Volunteers will eat 280 grams/day of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories.
Primary Outcome Measure Information:
Title
Change in lipid peroxidation
Description
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.
Time Frame
baseline, day 36, and day 64
Secondary Outcome Measure Information:
Title
Change in serum concentration of inflammatory markers
Description
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.
Time Frame
baseline, day 36 and day 64

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darshan Kelley, PhD
Organizational Affiliation
USDA, ARS, Western Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA, ARS, Western Human Nutrition Research Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23343675
Citation
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.
Results Reference
derived
Links:
URL
http://www.ars.usda.gov/Main/docs.htm?docid=11240
Description
USDA, ARS, WHNRC

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

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