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CompletedNCT02197754Updated Jan 16, 2015

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

An interventional study of Controlled diet in Healthy, sponsored by USDA Beltsville Human Nutrition Research Center. Completed at 1 site in United States. Open to participants aged 25 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-16.

Sponsored by USDA Beltsville Human Nutrition Research Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
28
Ages
25 Years to 75 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Healthy

Keywords

  • pharmacokinetics
  • polyphenol metabolites
  • lean individuals
  • obese individuals
03

In context

Lead sponsor

USDA Beltsville Human Nutrition Research Center is the lead sponsor of 30 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • 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

Interventions

  • OtherControlled 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.

06

What researchers measure

Primary outcomes

  1. Polyphenol metabolites - Wk 2

    Polyphenol metabolites will be measured in blood and urine after 2 weeks of a controlled diet.

    Time frame: 2 weeks after start of intervention

  2. 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.

    Time frame: 4 weeks after start of intervention

  3. 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.

    Time frame: 10 weeks after start of intervention

  4. Systemic inflammation - Wk 2

    Markers of inflammation (such as CRP, serum amyloid A, IL-6, IL-1B, TNF, and interferon-gamma will be measured.

    Time frame: 2 weeks after start of intervention

  5. Systemic Inflammation - Wk 4

    Markers of inflammation (such as CRP, serum amyloid A, IL-6, IL-1B, TNF, and interferon-gamma will be measured.

    Time frame: 4 weeks after start of intervention

  6. Systemic Inflammation - Wk 10

    Markers of inflammation (such as CRP, serum amyloid A, IL-6, IL-1B, TNF, and interferon-gamma will be measured.

    Time frame: 10 weeks after start of intervention

Secondary outcomes

  1. Gastrointestinal Health - Wk 2

    Gut permeability and inflammation will be measured in fecal samples.

    Time frame: 2 weeks after start of intervention

  2. Gastrointestinal Health - Wk 4

    Gut permeability and inflammation will be measured in fecal samples.

    Time frame: Wk 4

  3. Gastrointestinal Health - Wk 10

    Gut permeability and inflammation will be measured in fecal samples.

    Time frame: 10 weeks after start of intervention

07

Study locations

1 site
  • Beltsville Human Nutrition Center
    Beltsville, Maryland 20705, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02197754
Lead sponsor
USDA Beltsville Human Nutrition Research Center
Responsible party
Janet Novotny (Research Physiologist, USDA Beltsville Human Nutrition Research Center) — Principal investigator
First posted
Jul 23, 2014
Start date
Jul 2014
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Jan 16, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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