Blackberry Intake and Biomarkers of Cancer Risk

This study has been completed.
Sponsor:
Information provided by:
USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01293617
First received: January 24, 2011
Last updated: July 15, 2011
Last verified: July 2011
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293617

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

Additional Information:
No publications provided

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
Study First Received: January 24, 2011
Last Updated: July 15, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

ClinicalTrials.gov processed this record on August 01, 2014