Adaptation in Polyphenol Bioavailability and Bioactivity During Long Term Exposure to Polyphenol-Rich Foods

Study Overview
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Brief Summary
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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).

Conditions
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Healthy

Intervention / Treatment
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* Other: Controlled diet


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polyphenol Diet<br>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). | Other: Controlled diet<br>* Volunteers will be provided a controlled diet during the entirety of the 10 week treatment period. Meals will be prepared using traditional American foods. The controlled diet will include polyphenol-rich foods, including apples, berries, and green tea. A blend of multiple polyphenol-rich foods was chosen to investigate whole foods, multiple commodities, and multiple bioactives.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyphenol metabolites - Wk 2 | Polyphenol metabolites will be measured in blood and urine after 2 weeks of a controlled diet. | 2 weeks after start of intervention | 
| Polyphenol metabolites - Wk 4 | 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. | 4 weeks after start of intervention | 
| Polyphenol metabolites - Wk 10 | 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. | 10 weeks after start of intervention | 
| Systemic inflammation - Wk 2 | Markers of inflammation (such as CRP, serum amyloid A, IL-6, IL-1B, TNF, and interferon-gamma will be measured. | 2 weeks after start of intervention | 
| Systemic Inflammation - Wk 4 | Markers of inflammation (such as CRP, serum amyloid A, IL-6, IL-1B, TNF, and interferon-gamma will be measured. | 4 weeks after start of intervention | 
| Systemic Inflammation - Wk 10 | Markers of inflammation (such as CRP, serum amyloid A, IL-6, IL-1B, TNF, and interferon-gamma will be measured. | 10 weeks after start of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Health - Wk 2 | Gut permeability and inflammation will be measured in fecal samples. | 2 weeks after start of intervention | 
| Gastrointestinal Health - Wk 4 | Gut permeability and inflammation will be measured in fecal samples. | Wk 4 | 
| Gastrointestinal Health - Wk 10 | Gut permeability and inflammation will be measured in fecal samples. | 10 weeks after start of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, polyphenol metabolites, lean individuals, obese individuals