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Blackberry Intake and Biomarkers of Cancer Risk


N/A
40 Years
75 Years
Not Enrolling
Both
Healthy Volunteers

Thank you

Trial Information

Blackberry Intake and Biomarkers of Cancer Risk


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Change from baseline in 8-oxo-dG levels after 5 days

Outcome Time Frame:

Day 5

Safety Issue:

No

Principal Investigator

Janet A Novotny, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beltsville Human Nutrition Research Center, USDA

Authority:

United States: Institutional Review Board

Study ID:

HS36

NCT ID:

NCT01293617

Start Date:

January 2011

Completion Date:

April 2011

Related Keywords:

  • Healthy Volunteers

Name

Location

Beltsville Human Nutrition Research CenterBeltsville, Maryland  20705