Study to Identify Biomarkers for Protein Intake; a Randomized, Fully Controlled Feeding Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Differences between dietary periods in concentrations of potential biomerkers in blood and urine
研究概览
简要总结
Results from observational studies suggest a small beneficial association between protein and blood pressure that may be mainly attributable to the intake of protein from plant sources. In epidemiological studies biomarkers of dietary intake are useful to estimate intake more reliably. Dietary studies using biomarkers of protein intake generally show stronger associations with health outcomes. However, data on biomarkers for specific types of protein (e.g. from dairy, meat, grain and legumes) are scarce. Therefore the purpose of this study is to identify new biomarkers for the intake of protein from meat, dairy and grain. In addition the secondary purpose is to investigate whether intake of protein from these sources influences kidney filtration rate and urinary acid excretion differentially.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-40 years
- •BMI between 18.5 and 30 kg/m2
- •Healthy (As judged by the participant)
- •Written informed consent obtained
排除标准
- •Unable or unwilling to comply with study procedures.
- •Unusual dietary patterns, including high alcohol intakes (≥ 2 glasses/day) and a vegetarian diet
- •Recent (< 4 weeks) or current participation in a study with any investigational drug or dietary intervention
- •Usage of an energy restricted diet during the last two months
- •Weight loss or weight gain of 5 kg or more during the last two months
- •Stomach or bowel diseases
- •Kidney disorders
- •Diabetes, thyroid disease, other endocrine disorders
- •Prevalent cardiovascular disease
- •Extreme sports (>8h/ wk)
- •Usage of any prescribed medication except for oral contraceptives
- •Use of systemic antibiotics in the period of 3 month prior to the study
- •For women: pregnant or lactating
- •For women: not using oral contraceptives
- •For women: Unwilling to use oral contraceptives for consecutively for at least the total study duration
- •Liver function parameters (ALAT, ASAT, and γ-GT) and renal function parameters (Serum creatinin) outside the normal range
结局指标
主要结局
Differences between dietary periods in concentrations of potential biomerkers in blood and urine
时间窗: On the last day of every one week intervention period
Potential biomarkers that will be measured are urinary creatinin, sulphate, carnosine, 1-MH, 3-MH, taurine,14N/15N and creatin in blood. Furthermore, amino acid profiling will be done in blood and urine to detect differences between dietary periods
次要结局
- Differences between dietary period in estimated renal filtration(blood and urine collection on the last day of each intervention period)
- Differences between dietary periods in urinary acid excretion(urine collection on the last day of each intervention period)