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OpenTrials
Completed

NCT Number: NCT01293617

Blackberry Intake and Biomarkers of Cancer Risk

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.

Completed

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Key information

Conditions

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blackberries

Other

300 g blackberries daily for 5 days

Gelatin

Other

300 g gelatin per day for 5 days

Primary outcomes

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

    Time frame: Day 5

Sponsors and collaborators

Lead sponsor

United States Department of Agriculture (USDA)

Fed

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 10, 2011
Registry last updated
Jul 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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