Blackberry Intake and Biomarkers of Cancer Risk
This study has been completed.
Sponsor:
USDA Beltsville Human Nutrition Research Center
Information provided by:
USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01293617
First received: January 24, 2011
Last updated: July 15, 2011
Last verified: July 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition | Intervention |
|---|---|
|
Healthy Volunteers |
Other: Blackberries Other: Gelatin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Blackberry Intake and Biomarkers of Cancer Risk |
Resource links provided by NLM:
Further study details as provided by USDA Beltsville Human Nutrition Research Center:
Primary Outcome Measures:
- Change from baseline in 8-oxo-dG levels after 5 days [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 52 |
| Study Start Date: | January 2011 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Gelatin |
Other: Gelatin
300 g gelatin per day for 5 days
|
| Experimental: Blackberries |
Other: Blackberries
300 g blackberries daily for 5 days
|
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293617
Locations
| United States, Maryland | |
| Beltsville Human Nutrition Research Center | |
| Beltsville, Maryland, United States, 20705 | |
Sponsors and Collaborators
USDA Beltsville Human Nutrition Research Center
Investigators
| Principal Investigator: | Janet A Novotny, Ph.D. | Beltsville Human Nutrition Research Center, USDA |
More Information
Additional Information:
Recruiting Info 
No publications provided
| Responsible Party: | Janet A. Novotny, Ph.D., Beltsville Human Nutrition Research Center, USDA |
| ClinicalTrials.gov Identifier: | NCT01293617 History of Changes |
| Other Study ID Numbers: | HS36 |
| Study First Received: | January 24, 2011 |
| Last Updated: | July 15, 2011 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
ClinicalTrials.gov processed this record on May 23, 2013