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

• Sponsor: USDA, Western Human Nutrition Research Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01734070
• Collaborator: California Cherry Board (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 16.1
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation; Cardiovascular Diseases	Other: Cherry consumption	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Role of Cherry Consumption in Reducing Risk Factors for Human Chronic Inflammatory Diseases
• Study Start Date: May 1, 2003
• Actual Primary Completion Date: Sep 1, 2003
• Actual Study Completion Date: Sep 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Change in lipid peroxidation [baseline, day 36, and day 64]

   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

1. Change in serum concentration of inflammatory markers [baseline, day 36 and day 64]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• USDA, ARS, WHNRC

Publications

None provided.

• Responsible Party: USDA, Western Human Nutrition Research Center
• ClinicalTrials.gov Identifier: NCT01734070
• Other Study ID Numbers: FL40
• First Posted: Nov 27, 2012
• Last Update Posted: Feb 11, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by USDA, Western Human Nutrition Research Center: anthocyanins; catechins; chlorogenic acid; flavanol glycosides
• Additional relevant MeSH terms: Cardiovascular Diseases; Inflammation

Study Results

No Results Posted as of Feb 11, 2013