Blackberry Intake and Biomarkers of Cancer Risk

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Gelatin; Other: Blackberries

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Beltsville, Maryland, United States, 20705
      • Beltsville Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Gelatin	Other: Gelatin; 300 g gelatin per day for 5 days
Experimental: Blackberries	Other: Blackberries; 300 g blackberries daily for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in 8-oxo-dG levels after 5 days	Day 5

Collaborators and Investigators

• Sponsor: United States Department of Agriculture (USDA)
• Investigators: Principal Investigator: Janet A Novotny, Ph.D., Beltsville Human Nutrition Research Center, USDA

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: January 24, 2011
• First Submitted That Met QC Criteria: February 9, 2011
• First Posted (Estimate): February 10, 2011

Study Record Updates

• Last Update Posted (Estimate): July 18, 2011
• Last Update Submitted That Met QC Criteria: July 15, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: HS36