Skip to main content
OpenTrials
Completed

NCT Number: NCT02197754

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beltsville Human Nutrition Center

Beltsville, Maryland, 20705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Polyphenol metabolites - Wk 2

    Time frame: 2 weeks after start of intervention

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

  2. Polyphenol metabolites - Wk 4

    Time frame: 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.

  3. Polyphenol metabolites - Wk 10

    Time frame: 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.

  4. Systemic inflammation - Wk 2

    Time frame: 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.

  5. Systemic Inflammation - Wk 4

    Time frame: 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.

  6. Systemic Inflammation - Wk 10

    Time frame: 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.

Secondary outcomes

  1. Gastrointestinal Health - Wk 2

    Time frame: 2 weeks after start of intervention

    Gut permeability and inflammation will be measured in fecal samples.

  2. Gastrointestinal Health - Wk 4

    Time frame: Wk 4

    Gut permeability and inflammation will be measured in fecal samples.

  3. Gastrointestinal Health - Wk 10

    Time frame: 10 weeks after start of intervention

    Gut permeability and inflammation will be measured in fecal samples.

Sponsors and collaborators

Lead sponsor

USDA Beltsville Human Nutrition Research Center

Fed

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 23, 2014
Registry last updated
Jan 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.