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

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Controlled diet

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Beltsville, Maryland, United States, 20705
      • Beltsville Human Nutrition Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Polyphenol 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).

Other: Controlled diet; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: USDA Beltsville Human Nutrition Research Center

Publications and helpful links

Helpful Links

• Beltsville Human Nutrition Research Center Human Studies Website

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 21, 2014
• First Submitted That Met QC Criteria: July 22, 2014
• First Posted (Estimate): July 23, 2014

Study Record Updates

• Last Update Posted (Estimate): January 16, 2015
• Last Update Submitted That Met QC Criteria: January 15, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: pharmacokinetics; lean individuals; polyphenol metabolites; obese individuals
• Other Study ID Numbers: HS46