Blackberry Intake and Biomarkers of Cancer Risk

United States Department of Agriculture (USDA)

Status

Completed

Conditions

Healthy Volunteers

Treatments

Other: Gelatin

Other: Blackberries

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01293617

HS36

Details and patient eligibility

About

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.

Enrollment

52 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

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