Clinical trial NCT01734070: 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
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Cardiovascular Diseases
Keywords: anthocyanins
catechins
chlorogenic acid
flavanol glycosides
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: California Cherry Board
First posted: 2012-11-27
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in lipid peroxidation
timeFrame: baseline, day 36, and day 64
Secondary outcomes:
measure: Change in serum concentration of inflammatory markers
timeFrame: baseline, day 36 and day 64
Other outcomes:
Locations:
city: Davis
country: United States
facility: USDA, ARS, Western Human Nutrition Research Center
state: California
Study officials:
affiliation: USDA, ARS, Western Human Nutrition Research Center
name: Darshan Kelley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.