Phase 1 Seattle Dietary Biomarkers Development Center
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean metabolite concentration at Day 7 for Egg
研究概览
简要总结
The Seattle Dietary Biomarker Development Center (S-DBDC) aims to advance the science of measuring dietary intake by identification and validation of dietary biomarkers that improve upon self-reported diet. To accomplish this mission, the Seattle DBDC will carry out controlled feeding studies in healthy human volunteers. Metabolomics assays will be conducted on blood and urine specimens collected during the feeding studies for biomarker identification.
详细描述
The central mission of the Seattle Dietary Biomarker Development (DBDC) is to advance the science of measuring complex dietary exposures by rigorous identification and validation of dietary biomarkers that improve upon measurement error prone self-reported diet. To accomplish this mission, the Seattle DBDC will conduct a set of two, randomized, crossover, 3-period controlled feeding trials to develop metabolomics-based blood and urine biomarkers of 4 individual foods (1) beef and pinto beans or 2) eggs and black beans) and determine the dynamic ranges and half-lives of the urinary and blood-based dietary biomarkers. The two trials use the exact same sample protocol and study procedures and will be conducted successively.
For each feeding trial, 15 healthy adults will complete three feeding periods in random order (all protein from beef (trial 1) or eggs (trial 2); 1/2 protein from beef (trial 1) or eggs (trial 2); and 1/2 protein from pinto beans (trial 1) or black beans (trial 2); all protein from pinto beans (trial 1) or black beans (trial 2)). Each feeding period will consist of a 2-day run-in of controlled feeding followed by a 7-day feeding period, with about a 7-day washout between feeding periods. Blood and urine specimens will be collected before, at the mid-point, and at the end of each feeding period. In addition, an all-day pharmacokinetic evaluation will be conducted for 2 of the 3 feeding periods (all beef and all pinto beans (trial 1); all eggs and all black beans (trial 2)). Stool samples will be collected before, and at the end of each feeding period and stored for future studies. The collected specimens will be used for study outcomes and archived for future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Statisticians, Laboratory personnel
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
- •Healthy adults
- •Age 18 years and older
- •Willing to come to the Fred Hutch campus 16 times during the study
- •BMI 18.5-39.9 kg/m2
排除标准
- •History of gastrointestinal disorders (e.g., ulcerative colitis, Crohn disease, celiac sprue, Hereditary Non-polyposis Colorectal Cancer, familial adenomatous polyposis, pancreatic disease, liver disease)
- •Bleeding disorder that precludes blood draws
- •Previous gastrointestinal resection or bariatric surgery
- •Recent hospital admissions (in past 6 months) for heart disease (myocardial Infarction/cerebrovascular accident or congestive heart failure) or other cardiovascular disease/coronary artery disease condition under physician guided therapy that is not medically stable.
- •Cancer under active radiation or chemotherapy treatment (post-6 mos)
- •Pregnant or lactating
- •Weight change (±5% in 3 months)
- •Regular alcohol intake of >2 drinks/day (2 drinks being equivalent to 720 ml beer, 240 ml wine, or 90 ml spirits) and unwilling to abstain during feeding periods
- •Use of tobacco and/or marijuana, hookahs, e-cigarettes (e-cigs, vaping devices, etc) and not willing to abstain during feeding periods.
- •Use of illicit drugs and not willing to abstain during feeding periods.
- •BMI ≥40 kg/m2
- •Seated blood pressure > 140/90 mm Hg
- •Fasting clinical lab tests outside acceptable value as ascertained at a screening blood draw°
- •Food allergies/intolerances or major dislikes to foods used in the study menus; unwilling to consume study foods.
- •Current use of specific prescription medication (study staff will review medications to determine eligibility)**
- •Regular (daily to weekly) use of over-the-counter weight-loss aids, anti-inflammatories, and 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: protein supplements, soy, fiber, flaxseed, fish oil (incl. cod liver oil), probiotics, glucosamine and chondroitin (if vitamin supplement is MD prescribed - may continue). Study staff will review supplements to determine eligibility
- •Oral or IV antibiotic use in the past 3 months (could defer participation until 3 months post completion of course of antibiotics)
- •Inability to freely give informed consent.
- •Fasting clinical lab tests outside acceptable value as ascertained at a screening blood draw:
- •Description [Acceptable Values]
- •Glucose-Fasting: Serum Glucose [54-125 mg/dl]
- •Urea: BUN [6-50mg/dl]
- •Serum Creatinine [0.4-1.3 mg/dl]
- •eGFR: estimated GFR [>60ml/min]
- •Serum Sodium [133-146 mmol/L]
- •ALT/GPT Liver Enzyme [5-60 U/L]
- •AST/GOT Liver Enzyme [5-40 U/L]
- •Alkaline Phosphatase Liver Enzyme [20-135 U/L]
- •Total Bilirubin Liver Function [0.0-1.9 mg/dl]
- •Total Serum Protein [5-9.0 g/dl]
- •Albumin Serum Protein [3.5-5.9 g/dl]
- •LDL Cholesterol [<160 mg/dl]
- •Triglycerides [<500 mg/dl]
- •WBC White Blood Cells [3-10.5 K/uL]
- •HCT (women) Hematocrit [35-48 g/dl]
- •HCT (men) Hematocrit [37.5-49 g/dl]
- •**Medication use for exclusion:
- •Steroids (oral): daily oral any dose within 1 month of study, except OCP as noted below
- •Opiates: any use within 1 month of study
- •Anti-lipid medications that affect GI or renal function (ie. Fibrates)
- •Hyperglycemia medications other than metformin (ie. insulin, SGLT2 inhibitor, α-glucosidase inhibitor)
- •Psychiatric that affect metabolism/renal function (anti-psychotics, lithium)
- •Biologic/immune modulators (ie. RA, psoriasis, other rheumatologic/hematologic active disease)
- •Anti-coagulants (coumadin, heparin, Eliquis, etc.)
- •HIV/HAART, etc. (dyslipidemic)
研究组 & 干预措施
6) Black bean then egg then half black bean and half egg
干预措施: Controlled feeding study of eggs and/or black beans (Other)
1) Beef then half beef and half pinto bean then pinto bean
干预措施: Controlled feeding study of beef and/or pinto beans (Other)
2) Half pinto bean and half beef then pinto bean then beef
干预措施: Controlled feeding study of beef and/or pinto beans (Other)
3) Pinto Bean then Beef then half pinto bean and half beef
干预措施: Controlled feeding study of beef and/or pinto beans (Other)
4) Egg then half Egg and half black bean then black bean
干预措施: Controlled feeding study of eggs and/or black beans (Other)
5) Half egg and half black bean, then black bean then egg
干预措施: Controlled feeding study of eggs and/or black beans (Other)
结局指标
主要结局
Mean metabolite concentration at Day 7 for Egg
时间窗: Day 7
Mean metabolite concentration at Day 7 for Black Bean
时间窗: Day 7
Mean metabolite concentration at Day 7 for Beef
时间窗: Day 7
Mean area under the curve of 24-hour metabolite concentration for Pinto Bean
时间窗: 0-24 hours
Mean metabolite concentration at Day 7 for Pinto Bean
时间窗: Day 7
Mean area under the curve of 24-hour metabolite concentration for Egg
时间窗: 0-24 hours
Mean area under the curve of 24-hour metabolite concentration for Black Bean
时间窗: 0-24 hours
Mean area under the curve of 24-hour metabolite concentration for Beef
时间窗: 0-24 hours
次要结局
未报告次要终点
研究者
Marian Neuhouser
Professor, Cancer Prevention Program Head
Fred Hutchinson Cancer Center