Clinical trial NCT02197754: Adaptation in Polyphenol Bioavailability and Bioactivity During Long Term Exposure to Polyphenol-Rich Foods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: pharmacokinetics
polyphenol metabolites
lean individuals
obese individuals
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2014-07-23
Enrollment: 28
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 term (14 day), and long-term (10-week) consumption of polyphenol-rich fruits (berries and apple), and beverages (tea); and to determine the differential systemic and gut anti-inflammatory response between obese and lean individuals exposed to polyphenol-rich fruits (berries and apple), and beverages (tea).


Eligibility criteria: 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)

Primary outcomes:
measure: Polyphenol metabolites - Wk 2
timeFrame: 2 weeks after start of intervention
measure: Polyphenol metabolites - Wk 4
timeFrame: 4 weeks after start of intervention
measure: Polyphenol metabolites - Wk 10
timeFrame: 10 weeks after start of intervention
measure: Systemic inflammation - Wk 2
timeFrame: 2 weeks after start of intervention
measure: Systemic Inflammation - Wk 4
timeFrame: 4 weeks after start of intervention
measure: Systemic Inflammation - Wk 10
timeFrame: 10 weeks after start of intervention
Secondary outcomes:
measure: Gastrointestinal Health - Wk 2
timeFrame: 2 weeks after start of intervention
measure: Gastrointestinal Health - Wk 4
timeFrame: Wk 4
measure: Gastrointestinal Health - Wk 10
timeFrame: 10 weeks after start of intervention
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: Beltsville Human Nutrition Center
state: Maryland
Study officials:
References: