Natural Compounds to Reduce Nitrite in Meat Products: PHYTOME
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Change in N-nitroso compound (NOC) levels in faeces and urine measured as apparent total nitroso compounds (ATNC) between baseline levels at the start of the intervention and each intervention period
研究概览
简要总结
The PHYTOME project (Phytochemicals to reduce nitrite in meat products) is a major European Union (EU) co-funded research project that aims to develop innovative meat products in which the food additive nitrite has been replaced by natural compounds originating from fruits and vegetables. These biologically active compounds, also referred to as phytochemicals, are known to contribute to improved gut health and are added to the meat as natural extracts.
In a number of meat products, carefully selected combinations of natural antioxidants and other biologically active compounds occurring in vegetables, fruits and natural extracts such as coffee and tea, will be added during meat processing. Some of these compounds possess an antimicrobial activity allowing them to replace nitrite, whereas others possess a natural red colour that may contribute to the desired appearance of the products. Also, some of these compounds are known to protect colonic cells against damaging effects of cancer causing agents that may be formed in the large intestine after meat consumption.
The PHYTOME project will develop new technologies to introduce the natural extracts during processing to different types of meat products. These techniques will guarantee good sensory quality of the product as well as microbiological safety. Once these techniques have been developed and optimized at laboratory scale, the new type of products will be produced on an industrial scale. The health promoting effects of these products will be evaluated in a human dietary intervention study with healthy volunteers. After consumption of a fully controlled diet with either relatively high amounts of the traditional meat products or products produced following the new concept, faeces and colonic material will be collected and investigated for markers of colorectal cancer risk. These investigations will be performed in close collaboration with Research Institutes in the United Kingdom, Belgium, Italy and Greece, and will make use of the newest genomics techniques that are available.
详细描述
Rationale:
The aim of this project is to develop new meat processing technologies, resulting in innovative meat products that have low or no nitrite and that have been shown to contribute to improved human health. This will be achieved by introducing carefully selected mixtures of biologically compounds originating from natural plant extracts. The new meat products will be evaluated in a human dietary intervention study to establish their positive effect on cancer risk markers in colonic tissues using the newest genomics techniques available.
Objective:
This project aims to evaluate the health impact of newly developed low nitrite containing meat products using genomics markers in a human dietary intervention study.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy with a Body Mass Index (BMI) between 18-25, male or female
- •Between 18-70 years old
排除标准
- •Alcohol abuse up to 6 months before participation in this research
- •Current aberrations or insufficiency of kidney, liver, gut, heart or lungs
- •Current presence of persistent inflammation in the gut or liver
- •Current endocrine or metabolic aberrations
- •Current anaemia or infection
- •HIV infection or hepatitis
- •Use of antibiotics and other medication over the last 3 months
- •Current smokers
- •Vegetarians
- •Pregnant women
- •Participants of other intervention studies during this intervention period.
研究组 & 干预措施
Normal nitrite levels
Processed meat products enriched with natural compounds will contain normal nitrite levels.
干预措施: Processed meat product (Dietary Supplement)
Normal nitrite levels
Processed meat products enriched with natural compounds will contain normal nitrite levels.
干预措施: White meat wash-out (Dietary Supplement)
Normal nitrite levels
Processed meat products enriched with natural compounds will contain normal nitrite levels.
干预措施: Processed meat products enriched with natural compounds (Dietary Supplement)
Normal nitrite levels
Processed meat products enriched with natural compounds will contain normal nitrite levels.
干预措施: Drinking water containing nitrate up to acceptable daily intake level (ADI = 3.7 mg/kg bw) in combination with 300 grams of processed meat, white meat or processed meat enriched with natural compounds (Dietary Supplement)
Reduced nitrite levels
Processed meat products enriched with natural compounds will contain reduced nitrite levels
干预措施: Processed meat product (Dietary Supplement)
Reduced nitrite levels
Processed meat products enriched with natural compounds will contain reduced nitrite levels
干预措施: White meat wash-out (Dietary Supplement)
Reduced nitrite levels
Processed meat products enriched with natural compounds will contain reduced nitrite levels
干预措施: Processed meat products enriched with natural compounds (Dietary Supplement)
Reduced nitrite levels
Processed meat products enriched with natural compounds will contain reduced nitrite levels
干预措施: Drinking water containing nitrate up to acceptable daily intake level (ADI = 3.7 mg/kg bw) in combination with 300 grams of processed meat, white meat or processed meat enriched with natural compounds (Dietary Supplement)
结局指标
主要结局
Change in N-nitroso compound (NOC) levels in faeces and urine measured as apparent total nitroso compounds (ATNC) between baseline levels at the start of the intervention and each intervention period
时间窗: At baseline, at 2 weeks, at 4 weeks, at 6 weeks, and at 7 weeks
The faecal and urinal level of NOC is measured as Total Apparent Nitroso Compounds (ATNC) and used indicator of colonic endogenous nitrosation. It is known to significantly increase following strictly controlled diets high in red or processed meat.
Change in whole genome gene expression analyses in colonic biopsies and blood between baseline levels and each intervention period (transcriptomics)
时间窗: At baseline, at 2 weeks, at 4 weeks, and at 6 weeks
Colon biopsies and blood will be analysed for transcriptomic responses to the dietary changes. This will provide information on gene expression changes in the colon epithelium that may be linked with other parameters such as faecal NOC levels. This will also identify molecular pathways that can link dietary composition to processes involved in cancer development.
次要结局
- Change in urinary nitrate and creatine levels between baseline levels at the start of the intervention and each intervention period.(At baseline, at 2 weeks, at 4 weeks, at 6 weeks, and at 7 weeks)
- Genotyping of DNA(At baseline)
- Change in DNA methylation analyses of DNA isolated from colonic biopsies and blood (epigenetics) between baseline levels at the start of the intervention and each intervention period(At baseline, at 2 weeks, at 4 weeks, at 6 weeks)
- Change in enzyme activity of nitrate reductase in saliva between baseline levels at the start of the intervention and each intervention period(At baseline, at 2 weeks, at 4 weeks, at 6 weeks, and at 7 weeks)
- Change in the microbiome in feacal samples and in saliva between baseline levels at the start of the intervention and each intervention period(At baseline, at 2 weeks, at 4 weeks, at 6 weeks, and at 7 weeks)