Effects of Replacing Red and Processed Meat With Legume-based Foods on Nutrient Intake, Nutritional Status, Food Consumption, and Biomarkers of Cardiovascular Diseases, Colorectal Cancer, and Type 2 Diabetes in Healthy Working Age Men
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in the concentrations of plasma lipids as a measure of diet modification.
研究概览
简要总结
The aim of this study is to investigate the effects of partial replacement of red meat with legume-based foods on gut metabolism and markers for colorectal cancer as well as markers for cardiovascular diseases and type 2 diabetes in healthy working age men. The study participants will be stratified into two groups with different amounts of red meat in diet: 1) a diet containing 760 g of cooked and boneless red meat, supplying 25% of daily protein intake and 2) a diet supplying 20% of protein intake with legume-based foods and 5% of protein intake with red meat. The participants will get all meat and and legume-based foods from the research center; otherwise they will be asked to follow their habitual diet. Blood, urine, and stool samples will be collected at the baseline and at the end of the 6 week intervention, as well as BMI, blood pressure and body composition. Nutrient intake and food consumption will be analyzed from 4-day food records at the baseline and at the end of the intervention period.
详细描述
A human intervention study with healthy volunteers will be carried out to investigate the effects of partial replacement of red meat with legume-based foods on gut metabolism and markers for colorectal cancer as well as biomarkers for cardiovascular diseases and type 2 diabetes.
The study will be done in parallel-design, randomized fashion, with healthy male volunteers aged 20-65 years. Inclusion and exclusion criteria are described elsewhere. Duration of the intervention will be 6 weeks.
Intervention groups will be as follows (n=50/group):
Group 1: The habitual diet of participants is supplemented with 760 g of cooked and boneless red meat per week, representing the average meat consumption of Finnish men and supplying 25% of protein intake.
Group 2: The habitual diet of participants is supplemented with legume-based foods providing equal amount of protein as 560 g of red meat and 200 g of red meat per week.
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
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Omnivorous
- •No exclusion criteria listed below
排除标准
- •Food allergies against ingredients in foods supplemented in the study
- •Oral medication for any allergies
- •Regular use of food supplements
- •Extreme sports
- •Inflammatory bowel disease
- •Colon irritable
- •Coeliac disease
- •Any kind of cancer within 5 years
- •Continuous antibiotics or less than 3 months of the latest antibiotics use
- •Type 1 or 2 diabetes
- •Hypercholesterolemia
- •Hormonal, liver or kidney disease
- •Alcohol consumption more than 24 measures per week
- •Smoking, using snuff
结局指标
主要结局
Changes in the concentrations of plasma lipids as a measure of diet modification.
时间窗: 6 weeks
The changes in the concentrations of total, LDL, and HDL cholesterol as well as plasma triglycerides.
Changes in the intake of nutrients and nutritional status of participants as a measure of diet modification.
时间窗: 6 weeks
The changes in the markers for nutritional status in plasma/serum: hemoglobin, transferrin receptor, ferritin, vitamin B12, folate. The intake of nutrients is calculated from 4-day food records.
Changes in the composition of gut microbiota as a measure of modification of dietary protein composition.
时间窗: 6 weeks
The composition of gut microbiota is measured using HITChip phylogenetic microarray.
次要结局
- Changes in the concentrations of N-nitroso compounds in feces.(6 weeks)
研究者
Anne-Maria Pajari
Adjunct Professor
University of Helsinki