Blackberry Intake and Biomarkers of Cancer Risk

Study Overview
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Brief Summary
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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.

Official Title
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Blackberry Intake and Biomarkers of Cancer Risk

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: Blackberries
* Other: Gelatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Gelatin<br> | Other: Gelatin<br>* 300 g gelatin per day for 5 days<br>|
| Experimental: Blackberries<br> | Other: Blackberries<br>* 300 g blackberries daily for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

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