Adaptation in Polyphenol Bioavailability and Bioactivity During Long Term Exposure to Polyphenol-Rich Foods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Polyphenol metabolites - Wk 2
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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)
结局指标
主要结局
Polyphenol metabolites - Wk 2
时间窗: 2 weeks after start of intervention
Polyphenol metabolites will be measured in blood and urine after 2 weeks of a controlled diet.
Polyphenol metabolites - Wk 10
时间窗: 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.
Systemic Inflammation - Wk 10
时间窗: 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.
Polyphenol metabolites - Wk 4
时间窗: 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.
Systemic inflammation - Wk 2
时间窗: 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.
Systemic Inflammation - Wk 4
时间窗: 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.
次要结局
- 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)
研究者
Janet Novotny
Research Physiologist
USDA Beltsville Human Nutrition Research Center