Healthy
Conditions
Keywords
pharmacokinetics, polyphenol metabolites, lean individuals, obese individuals
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).
Interventions
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.
Sponsors
Study design
Eligibility
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Gastrointestinal Health - Wk 2 | 2 weeks after start of intervention | Gut permeability and inflammation will be measured in fecal samples. |
Countries
United States