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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02197754
Enrollment
28
Registered
2014-07-23
Start date
2014-07-31
Completion date
2014-12-31
Last updated
2015-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

pharmacokinetics, polyphenol metabolites, lean individuals, obese individuals

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).

Interventions

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.

Sponsors

USDA Beltsville Human Nutrition Research Center
Lead SponsorFED

Study design

Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Systemic Inflammation - Wk 1010 weeks after start of interventionMarkers of inflammation (such as CRP, serum amyloid A, IL-6, IL-1B, TNF, and interferon-gamma will be measured.
Polyphenol metabolites - Wk 1010 weeks after start of interventionPolyphenol 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.
Systemic inflammation - Wk 22 weeks after start of interventionMarkers of inflammation (such as CRP, serum amyloid A, IL-6, IL-1B, TNF, and interferon-gamma will be measured.
Systemic Inflammation - Wk 44 weeks after start of interventionMarkers of inflammation (such as CRP, serum amyloid A, IL-6, IL-1B, TNF, and interferon-gamma will be measured.
Polyphenol metabolites - Wk 22 weeks after start of interventionPolyphenol metabolites will be measured in blood and urine after 2 weeks of a controlled diet.
Polyphenol metabolites - Wk 44 weeks after start of interventionPolyphenol 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.

Secondary

MeasureTime frameDescription
Gastrointestinal Health - Wk 4Wk 4Gut permeability and inflammation will be measured in fecal samples.
Gastrointestinal Health - Wk 1010 weeks after start of interventionGut permeability and inflammation will be measured in fecal samples.
Gastrointestinal Health - Wk 22 weeks after start of interventionGut permeability and inflammation will be measured in fecal samples.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026