Blackberry Intake and Biomarkers of Cancer Risk

Healthy Volunteers Clinical Trial

Official title:

Blackberry Intake and Biomarkers of Cancer Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293617
• Other study ID #: HS36
• Status: Completed
• Phase: N/A
• First received: January 24, 2011
• Last updated: July 15, 2011
• Start date: January 2011
• Est. completion date: April 2011

Study information

• Verified date: July 2011
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Blackberries
300 g blackberries daily for 5 days
• Gelatin
300 g gelatin per day for 5 days

Locations

Country	Name	City	State
United States	Beltsville Human Nutrition Research Center	Beltsville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in 8-oxo-dG levels after 5 days		Day 5	No

External Links

•   Recruiting Info