Blackberry Intake and Biomarkers of Cancer Risk

Not Applicable

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT01293617
• Lead Sponsor: United States Department of Agriculture (USDA)

Brief Summary

Berry components have been shown to influence cancer processes in cell culture studies. The investigators will conduct a study to investigate if blackberries influence the same cancer processes in a human feeding study.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-10
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-15
• Last Update Posted: 2011-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Non-smoking men and women
• Aged 40-75
• BMI 19-38 kg/m2

Exclusion Criteria

• Younger then 40 ears old or older than 75 years old
• BMI less than 19 or greater than 38
• Use of blood-thinning medications such as warfarin, dicumarol, or anisinidione
• Presence of kidney disease, liver disease, gout, certain cancers, untreated thyroid, gastrointestinal, other metabolic diseases or malabsorption syndromes
• Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
• Fasting triglycerides greater than 300 mg/dL
• Fasting glucose greater than 126 mg/dL
• History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g. vegetarians, very low fat diets, high protein diets)
• Use of prescription of over-the-counter antiobesity medications or supplements during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity
• Active cardiovascular disease
• Use of any tobacco products in the past 6 months
• Use of oral or IV antibiotics during the month preceding the study or during the study
• Unwillingness to abstain from vitamin, mineral, and herbal supplements for two weeks prior to the start of the study
• Known (self-reported) allergy or adverse reaction to blackberries or gelatin
• Unable or unwilling to give informed consent or communicate with study staff
• Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
• Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in 8-oxo-dG levels after 5 days	Day 5

Trial Locations

Locations (1)

Beltsville Human Nutrition Research Center; 🇺🇸 Beltsville, Maryland, United States