Healthy Volunteers
Conditions
Brief 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.
Interventions
OTHERBlackberries
300 g blackberries daily for 5 days
OTHERGelatin
300 g gelatin per day for 5 days
Sponsors
United States Department of Agriculture (USDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in 8-oxo-dG levels after 5 days | Day 5 |
Countries
United States
Outcome results
None listed