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

Beltsville Human Nutrition Research Center (BHNRC)

Status: Completed

Conditions: Healthy

Treatments: Other: Controlled diet

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02197754

HS46

Details and patient eligibility

About

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).

Enrollment: 28 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

28 participants in 1 patient group

Polyphenol Diet

Experimental group

Description:

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).

Treatment:

Other: Controlled diet