Status:
COMPLETED
Adaptation in Polyphenol Bioavailability and Bioactivity During Long Term Exposure to Polyphenol-Rich Foods
Lead Sponsor:
USDA Beltsville Human Nutrition Research Center
Conditions:
Healthy
Eligibility:
All Genders
25-75 years
Phase:
NA
Brief Summary
There are two primary objectives to be addressed in this study: to assess the differential response in bioavailability and metabolic pathways between lean and obese individuals exposed to acute, short...
Eligibility Criteria
Inclusion
- Exclusion Criteria:
- Younger than 25 years old or older than 75 years old
- Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisindione)
- Presence of any gastrointestinal disease, metabolic disease, bariatric surgery, or malabsorption syndromes that may interfere with the study goals
- Have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the study
- 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 or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine) 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 (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months).
- Use of any tobacco products in past 3 months
- Unwillingness to abstain from herbal supplements for two weeks prior to the study and during the study
- Known (self-reported) allergy or adverse reaction to study foods
- Unable or unwilling to give informed consent or communicate with study staff
- Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion)
Exclusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02197754
Start Date
July 1 2014
End Date
December 1 2014
Last Update
January 16 2015
Active Locations (1)
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1
Beltsville Human Nutrition Center
Beltsville, Maryland, United States, 20705