Expired Study
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Beltsville, Maryland 20705


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.


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


Study is Available At:


Original ID:

HS36


NCT ID:

NCT01293617


Secondary ID:


Study Acronym:


Brief Title:

Blackberry Intake and Biomarkers of Cancer Risk


Official Title:

Blackberry Intake and Biomarkers of Cancer Risk


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

United States Department of Agriculture


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

52


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Janet A Novotny, Ph.D.
Principal Investigator
Beltsville Human Nutrition Research Center, USDA

Study Dates

Start Date:January 2011
Completion Date:April 2011
Completion Type:Actual
Primary Completion Date:April 2011
Primary Completion Type:Actual
Verification Date:July 2011
Last Changed Date:July 15, 2011
First Received Date:January 24, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change from baseline in 8-oxo-dG levels after 5 days
Time Frame:Day 5
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Blackberries
Description:300 g blackberries daily for 5 days
Arm Name:Blackberries
Intervention Type:Other
Name:Gelatin
Description:300 g gelatin per day for 5 days
Arm Name:Gelatin

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Gelatin
Study Arm Type:Experimental
Arm Name:Blackberries

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:United States Department of Agriculture

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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