Screening to Validate and Identify Nutrition-related Biomarkers for Definded Food Groups (Dairy Products, Whole Grain, Processed Meat, Vegetarian Sausage Alternatives)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Fatty acids, concentration in %fatty acid methyl esters
研究概览
简要总结
The Biomarker study will be conducted (i) to establish biomarker profiles that reflect the daily diet and regularly dietary habits, (ii) to complement self-reported dietary habits and (iii) to reduce gaps between self-reported information and real dietary intake. The study aims to assess relationships between defined nutrient intake (four groups: 1. Milk and dairy products, 2. Whole-grain products (rich in soluble fibers), 3. Sausage and processed meat (pork), 4. Meat-free sausage and meat alternatives (based on egg, soy) and resulting biochemical markers in human samples (plasma, serum, 24 h urine). In a next step, we will focus on unraveling the connection of the established diet-related metabolites with biomarkers of health and disease status, with focus on cardiovascular diseases (CVD).
详细描述
Within the scope of the present study, biomarkers or biomarker profiles are to be identified which reflect the daily diet and eating habits (focus: mixed diet / Western diet, vegetarians, vegans) in order to supplement or complete the information from diet protocols.
The chosen study design enables relationships between a defined nutrient intake in the form of a standardized diet over five days (four groups with 40 subjects each; group 1: Milk and dairy products, group 2: Whole grain products (rich in soluble fiber), group 3: Sausage and processed meat (pork), group 4: Meat-free sausage and meat alternatives (based on egg, soy) and the resulting biochemical markers in the human samples (plasma, serum, whole blood, 24-hour urine).
In addition, one subgroup (n = 12) consumed a test meal with the study foods on day 6 after the 5-day standardized diet. Before the test meal (time 0) and at intervals of 30, 60, 120, 180 min, blood samples are taken (postprandial profiling) in order to examine the brief increase in nutrients from the study foods in the human samples.
The aim of the study is i) to validate already established biomarkers and ii) to identify new biomarkers / patterns.
In the further course of the study, the identified and validated nutrition-associated biomarkers are to be linked to parameters of the health and disease status, whereby in particular the connection to cardiovascular risk factors and endpoints is considered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females (before menopause) and males
- •Age: 20 < 40 years
- •BMI ≥ 18 < 25 kg/m2
- •Participants must be subjectively healthy
- •Compatibility to one of the four planned groups as confirmed by lifestyle and nutrition-related questionnaires plus food frequency protocol (FFP) over five days
- •Precondition: stable eating habits at least one year before enrollment
排除标准
- •Subjects with any acute or chronic disease (tumor, infection, other), gastrointestinal diseases, dia-betes mellitus (type I, II), chronic renal disease, diseases of the parathyroid, diseases necessitating regular phlebotomies
- •Intake of additional dietary supplements (e.g. fish oil capsules, vitamins, minerals etc.)
- •Weight loss or weight gain (> 3 kg) during the last three months before study begin
- •Pregnancy or lactation
- •Transfusion of blood in the last three months before blood sample taking
结局指标
主要结局
Fatty acids, concentration in %fatty acid methyl esters
时间窗: Change from baseline after 5 days of the standardised diet
Fatty acids distribution in plasma lipids, inclusive odd-chain fatty acids
次要结局
- Homoarginine, concentration(Change from baseline after 5 days of the standardised diet)
- Trimethylamine N-oxide, concentration(Change from baseline after 5 days of the standardised diet)
- Galactonate, concentration(Change from baseline after 5 days of the standardised diet)
- Galactono-1,5-lactone, concentration(Change from baseline after 5 days of the standardised diet)
- 1-methylhistidineanserine, concentration(Change from baseline after 5 days of the standardised diet)
- Galactitol, concentration(Change from baseline after 5 days of the standardised diet)
- 3-methylhistidineanserine, concentration(Change from baseline after 5 days of the standardised diet)
- Syringol sulfate, concentration(Change from baseline after 5 days of the standardised diet)
- Wheat germ agglutinin, concentration(Change from baseline after 5 days of the standardised diet)
- 3-phenyllactic acid, concentration(Change from baseline after 5 days of the standardised diet)
- Asymmetric dimethylarginine, concentration(Change from baseline after 5 days of the standardised diet)
- Alkylresorcinol, concentration(Change from baseline after 5 days of the standardised diet)
研究者
Christine Dawczynski,PhD
PhD
University of Jena