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Blackberry Intake and Biomarkers of Cancer Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01293617
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : July 18, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Healthy Volunteers Other: Blackberries Other: Gelatin

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Blackberry Intake and Biomarkers of Cancer Risk
Study Start Date : January 2011
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Gelatin
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in 8-oxo-dG levels after 5 days [ Time Frame: Day 5 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293617


Locations
United States, Maryland
Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Sponsors and Collaborators
United States Department of Agriculture (USDA)
Investigators
Principal Investigator: Janet A Novotny, Ph.D. Beltsville Human Nutrition Research Center, USDA
More Information

Additional Information:
Responsible Party: Janet A. Novotny, Ph.D., Beltsville Human Nutrition Research Center, USDA
ClinicalTrials.gov Identifier: NCT01293617     History of Changes
Other Study ID Numbers: HS36
First Posted: February 10, 2011    Key Record Dates
Last Update Posted: July 18, 2011
Last Verified: July 2011