University of California (UC), Davis Dietary Biomarkers Development Center
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change in plasma metabolomics profile
研究概览
简要总结
The purpose of this research is to find a set of markers in the blood and/or urine that can be linked to consumption of specific fruits and vegetables. This will allow for better understanding of the link between diet and health-related outcomes. Furthermore, the results of this study will lead to the development of new methods to evaluate the nutritional status of individuals in both community and clinical settings. Food frequency questionnaires and diaries/recalls can be affected by intentional or unintentional misreporting, and thus can create errors in determining nutritional status. This study will lead to the development of an objective way to assess the consumption of specific fruits and vegetables by the general population.
详细描述
The purpose of this research is to find a set of markers in the blood and/or urine that can be linked to consumption of specific fruits and vegetables. This will allow for better understanding of the link between diet and health-related outcomes. Furthermore, the results of this study will lead to the development of new methods to evaluate the nutritional status of individuals in both community and clinical settings. Food frequency questionnaires and diaries/recalls can be affected by intentional or unintentional misreporting, and thus can create errors in determining nutritional status. This study will lead to the development of an objective way to assess the consumption of specific fruits and vegetables by the general population.
This study includes 3 aims to identify and then validate urine and plasma biomarkers associated with fruit and vegetable intake. Aim 1 will use a randomized crossover dietary intervention to determine the dose and time response of metabolites in plasma and urine associated with exposure to a mixture of MyPlate fruits and vegetables. Aim 2 will use a parallel design, controlled diet intervention to determine whether the biomarkers of fruit and vegetable intake determined in Aim 1 are predictors of consumption in the context of a defined dietary pattern. Aim 3 will be a cross-sectional validation arm that determines if the biomarkers of food intake developed in Aims 1 and 2 have predictive value reflecting recent and habitual consumption of these foods in a heterogeneous and diverse population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) 18.5-39.9 kg/m^2
- •Willingness to provide urine and have blood drawn
排除标准
- •Pregnancy or lactation
- •Allergy or aversion to foods provided in test diet
- •History of gastrointestinal disorders including the following:
- •Ulcerative colitis or Crohn's disease
- •Celiac sprue
- •Hereditary non-polyposis colorectal cancer (HNPCC)
- •Familial adenomatous polyposis
- •Pancreatic disease
- •Liver disease
- •Previous gastrointestinal resection or bariatric surgery
- •Bleeding disorders that preclude blood draws
- •Recent hospital admissions (past 6 months) for myocardial infarction (MI), cerebrovascular accident (CVA), or congestive heart failure (CHF)
- •Cardiovascular disease (CVD) under physician guided therapy that is not medically stable
- •Cancer under radiation or chemotherapy treatment that is active or within 6 months of treatment
- •Weight change (± 5% in the last 3 months)
- •Regular alcohol intake of > 2 drinks/day (equivalent to 720 mL of beer, 240 mL of wine, or 90 mL of spirits), and unwilling to abstain during feeding periods
- •Use of tobacco and/or marijuana, hookahs, e-cigarettes, or vapes and not willing to abstain during feeding periods
- •Use of illicit drugs and not willing to abstain during feeding periods
- •BMI >40 kg/m^2
- •Regular (daily to weekly) use of over-the-counter (OTC) weight-loss aids and unwilling or unable to stop taking these during feeding periods
- •Regular (daily to weekly) use of OTC anti-inflammatories and unwilling or unable to stop taking these during feeding periods
- •Unwilling to stop taking OTC dietary supplements that interfere with the test foods being studied including pills, chewables, liquids or powders for the following (may continue if vitamin supplement is prescribed by a medical doctor):
- •Protein supplements
- •Fish oil (including cod liver oil)
- •Carotenoids
- •Other antioxidants
- •Other phytochemicals
- •Glucosamine
- •Chondroitin
- •Oral or IV antibiotic use in the past 6 months (could defer participation until 6 months post-completion of course of antibiotics)
- •Seated blood pressure >140/90 mmHg
- •Fasting clinical lab values outside of the following ranges:
- •Fasting Glucose: 54-125 mg/dL
- •Urea: 6-50 mg/dL
- •Creatinine: 0.4-1.3 mg/dL
- •Estimated Glomerular Filtration Rate (eGFR): >60 mL/min
- •Sodium: 133-146 mmol/L
- •Alanine Transaminase (ALT): 5-60 U/L
- •Aspartate Aminotransferase (AST): 5-40 U/L
- •Alkaline Phosphatase (ALP): 20-135 U/L
- •Total Bilirubin: 0.0-1.9 mg/dL
- •Total Protein: 5-9.0 g/dL
- •Albumin: 3.5-5.9 d/L
- •Low-density Lipoprotein (LDL) Cholesterol: <160 mg/dL
- •Triglycerides: <500
- •White Blood Cells: 3-10.5 Kl/µL
- •Hematocrit: 35-48 g/dL (women), 37.5-49 g/dL (men)
- •Current use of the following prescription medications:
- •Steroids (oral): daily oral any dose within 1 month of study (except for oral contraceptive pills)
- •Opiates: any use within 1 month of study
- 另有 7 项未显示
研究组 & 干预措施
Aim 1 Group 6
Order of Treatments:
Meal Challenge 3, Meal Challenge 2, Meal Challenge 1
干预措施: Aim 1 Meal Challenge 2 (Other)
Aim 1 Group 6
Order of Treatments:
Meal Challenge 3, Meal Challenge 2, Meal Challenge 1
干预措施: Aim 1 Meal Challenge 1 (Other)
Aim 1 Group 3
Order of Treatments:
Meal Challenge 2, Meal Challenge 3, Meal Challenge 1
干预措施: Aim 1 Meal Challenge 1 (Other)
Aim 1 Group 3
Order of Treatments:
Meal Challenge 2, Meal Challenge 3, Meal Challenge 1
干预措施: Aim 1 Meal Challenge 2 (Other)
Aim 1 Group 3
Order of Treatments:
Meal Challenge 2, Meal Challenge 3, Meal Challenge 1
干预措施: Aim 1 Meal Challenge 3 (Other)
Aim 1 Group 1
Order of Treatments:
Meal Challenge 1, Meal Challenge 2, Meal Challenge 3
干预措施: Aim 1 Meal Challenge 1 (Other)
Aim 1 Group 1
Order of Treatments:
Meal Challenge 1, Meal Challenge 2, Meal Challenge 3
干预措施: Aim 1 Meal Challenge 2 (Other)
Aim 1 Group 1
Order of Treatments:
Meal Challenge 1, Meal Challenge 2, Meal Challenge 3
干预措施: Aim 1 Meal Challenge 3 (Other)
Aim 1 Group 2
Order of Treatments:
Meal Challenge 1, Meal Challenge 3, Meal Challenge 2
干预措施: Aim 1 Meal Challenge 1 (Other)
Aim 1 Group 2
Order of Treatments:
Meal Challenge 1, Meal Challenge 3, Meal Challenge 2
干预措施: Aim 1 Meal Challenge 2 (Other)
Aim 1 Group 2
Order of Treatments:
Meal Challenge 1, Meal Challenge 3, Meal Challenge 2
干预措施: Aim 1 Meal Challenge 3 (Other)
Aim 1 Group 4
Order of Treatments:
Meal Challenge 2, Meal Challenge 1, Meal Challenge 3
干预措施: Aim 1 Meal Challenge 1 (Other)
Aim 1 Group 4
Order of Treatments:
Meal Challenge 2, Meal Challenge 1, Meal Challenge 3
干预措施: Aim 1 Meal Challenge 2 (Other)
Aim 1 Group 4
Order of Treatments:
Meal Challenge 2, Meal Challenge 1, Meal Challenge 3
干预措施: Aim 1 Meal Challenge 3 (Other)
Aim 1 Group 5
Order of Treatments:
Meal Challenge 3, Meal Challenge 1, Meal Challenge 2
干预措施: Aim 1 Meal Challenge 1 (Other)
Aim 1 Group 5
Order of Treatments:
Meal Challenge 3, Meal Challenge 1, Meal Challenge 2
干预措施: Aim 1 Meal Challenge 2 (Other)
Aim 1 Group 5
Order of Treatments:
Meal Challenge 3, Meal Challenge 1, Meal Challenge 2
干预措施: Aim 1 Meal Challenge 3 (Other)
Aim 1 Group 6
Order of Treatments:
Meal Challenge 3, Meal Challenge 2, Meal Challenge 1
干预措施: Aim 1 Meal Challenge 3 (Other)
Aim 2 Typical American Diet
干预措施: Aim 2 Typical American Diet (Other)
Aim 2 Typical American Diet Plus Test Foods
干预措施: Aim 2 Typical American Diet Plus Test Foods (Other)
Aim 2 Dietary Guidelines for Americans Diet Plus Test Foods
干预措施: Aim 2 Dietary Guidelines for Americans Diet Plus Test Foods (Other)
结局指标
主要结局
Change in plasma metabolomics profile
时间窗: Aim 1: day 3, 8, 13; overnight fasted and post prandial 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 6 hour, 7 hour, 8 hour, 24 hour. Aim 2: days 3, 9, 10. Aim 3: day 4.
Plasma metabolites will be measured by ultra-performance liquid chromatography mass spectrometry (UPLC-MS) before and after consumption of no, low, or high doses of study fruits and vegetables. Change will be assessed by the appearance of and change in levels of dietary-derived metabolites, which are candidate dietary biomarkers.
Change in urine metabolomics profile
时间窗: Aim 1: day 3, 8, 13; overnight fasted and post prandial 0-2 hours, 2-4 hours, 4-6 hours, 6-8 hours, 8-24 hours. Aim 2: day 3, 9, 10; Aim 3: day 4.
Urine metabolites will be measured by ultra-performance liquid chromatography mass spectrometry (UPLC-MS) before and after consumption of no, low, or high doses of study fruits and vegetables. Change will be assessed by the appearance of and change in levels of dietary-derived metabolites, which are candidate dietary biomarkers.
次要结局
- Habitual consumption of fruits and vegetables(Day 1)
- Diet adherence(Aim 1: day 3, 8, 13. Aim 2: day 3, 6, and 9.)
- Acute consumption of fruits and vegetables(Days 1, 2, 3.)