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

NCT02197754 | Completed

• 1 other identifier: HS46
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

pharmacokinetics; polyphenol metabolites; lean individuals; obese individuals

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Gastrointestinal Health - Wk 2

  2 weeks after start of intervention

• Gastrointestinal Health - Wk 4

  Wk 4

• Gastrointestinal Health - Wk 10

  10 weeks after start of intervention

Study Arms (1)

Polyphenol Diet

EXPERIMENTAL

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

Interventions

Controlled diet OTHER

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.

Polyphenol Diet

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• USDA Beltsville Human Nutrition Research Center: lead

Study Sites (1)

Beltsville Human Nutrition Center

Beltsville, Maryland, 20705, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Physiologist

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 23, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 16, 2015

Record last verified: 2015-01

Locations

US (1)