NCT01734070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
Last Updated

February 11, 2013

Status Verified

February 1, 2013

Enrollment Period

4 months

First QC Date

November 20, 2012

Last Update Submit

February 7, 2013

Conditions

InflammationCardiovascular Diseases

Keywords

anthocyaninscatechinschlorogenic acidflavanol glycosides

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, day 36, and day 64

Secondary Outcomes (1)

  • Change in serum concentration of inflammatory markers

    baseline, day 36 and day 64

Study Arms (1)

Cherry consumption

EXPERIMENTAL

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

Interventions

Cherry consumptionOTHER

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

Cherry consumption

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

Related Publications (1)

  • 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.

    PMID: 23343675DERIVED

Related Links

MeSH Terms

Conditions

InflammationCardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Darshan Kelley, PhD

    USDA, ARS, Western Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2012

First Posted

November 27, 2012

Study Start

May 1, 2003

Primary Completion

September 1, 2003

Study Completion

September 1, 2004

Last Updated

February 11, 2013

Record last verified: 2013-02

Locations

US(1)