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Blackberry Intake and Biomarkers of Cancer Risk

This study has been completed.
Information provided by:
USDA Beltsville Human Nutrition Research Center Identifier:
First received: January 24, 2011
Last updated: July 15, 2011
Last verified: July 2011
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 Intervention
Healthy Volunteers Other: Blackberries Other: Gelatin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Blackberry Intake and Biomarkers of Cancer Risk

Resource links provided by NLM:

Further study details as provided by USDA Beltsville Human Nutrition Research Center:

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

Estimated Enrollment: 52
Study Start Date: January 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Gelatin Other: Gelatin
300 g gelatin per day for 5 days
Experimental: Blackberries Other: Blackberries
300 g blackberries daily for 5 days


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

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
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Please refer to this study by its identifier: NCT01293617

United States, Maryland
Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Sponsors and Collaborators
United States Department of Agriculture (USDA)
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 Identifier: NCT01293617     History of Changes
Other Study ID Numbers: HS36
Study First Received: January 24, 2011
Last Updated: July 15, 2011 processed this record on August 18, 2017