Adaptation in Polyphenol Bioavailability and Bioactivity During Long Term Exposure to Polyphenol-Rich Foods
- Conditions
- Healthy
- Interventions
- Other: Controlled diet
- Registration Number
- NCT02197754
- Lead Sponsor
- USDA Beltsville Human Nutrition Research Center
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Not provided
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Polyphenol Diet Controlled diet After 2 weeks of adaptation to a controlled diet, polyphenol-rich fruits (berries and apple) and beverages (tea) will be fed (8 wks) as part of a controlled diet (10 wks total).
- Primary Outcome Measures
Name Time Method Polyphenol metabolites - Wk 2 2 weeks after start of intervention Polyphenol metabolites will be measured in blood and urine after 2 weeks of a controlled diet.
Polyphenol metabolites - Wk 10 10 weeks after start of intervention Polyphenol metabolites will be measured in blood and urine after 10 weeks of a controlled diet. Weeks 3 through 10 will contain fruits and beverage rich in polyphenols.
Systemic Inflammation - Wk 10 10 weeks after start of intervention Markers of inflammation (such as CRP, serum amyloid A, IL-6, IL-1B, TNF, and interferon-gamma will be measured.
Polyphenol metabolites - Wk 4 4 weeks after start of intervention Polyphenol metabolites will be measured in blood and urine after 4 weeks of a controlled diet. Weeks 3 and 4 will contain fruits and beverage rich in polyphenols.
Systemic inflammation - Wk 2 2 weeks after start of intervention Markers of inflammation (such as CRP, serum amyloid A, IL-6, IL-1B, TNF, and interferon-gamma will be measured.
Systemic Inflammation - Wk 4 4 weeks after start of intervention Markers of inflammation (such as CRP, serum amyloid A, IL-6, IL-1B, TNF, and interferon-gamma will be measured.
- Secondary Outcome Measures
Name Time Method Gastrointestinal Health - Wk 2 2 weeks after start of intervention Gut permeability and inflammation will be measured in fecal samples.
Gastrointestinal Health - Wk 4 Wk 4 Gut permeability and inflammation will be measured in fecal samples.
Gastrointestinal Health - Wk 10 10 weeks after start of intervention Gut permeability and inflammation will be measured in fecal samples.
Trial Locations
- Locations (1)
Beltsville Human Nutrition Center
🇺🇸Beltsville, Maryland, United States