Blackberry Intake and Biomarkers of Cancer Risk
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy-volunteers
Started Jan 2011
Shorter than P25 for not_applicable healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 24, 2011
CompletedFirst Posted
Study publicly available on registry
February 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedJuly 18, 2011
July 1, 2011
3 months
January 24, 2011
July 15, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in 8-oxo-dG levels after 5 days
Day 5
Study Arms (2)
Gelatin
PLACEBO COMPARATORBlackberries
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Non-smoking men and women
- Aged 40-75
- BMI 19-38 kg/m2
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janet A Novotny, Ph.D.
Beltsville Human Nutrition Research Center, USDA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
January 24, 2011
First Posted
February 10, 2011
Study Start
January 1, 2011
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
July 18, 2011
Record last verified: 2011-07