Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cardiovascular Diseases
  • Colorectal Cancer
  • Type2 Diabetes
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 20 years and 65 years
Gender
Only males

Description

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 do...

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. The consumption of red meat and legumes will be kept stable throughout the intervention and participants are advised to avoid consuming any red meat or legumes in addition to those provided from the research center. We also aim to investigate, whether replacing red meat with legumes induces other changes in diet. This information is be important if increasing legume consumption is recommended at the population level. Before starting the intervention, participants will get dietary advice how to follow their diets. They will get the red meat and legume-based foods for free to help to implement the diets and to enhance compliance. Blood, urine and fecal samples will be collected at the baseline and at the end of the intervention. Nutrient intake and food consumption during the intervention will be analyzed from 4-day food records at the baseline and at the end. Nutrient intakes will be calculated using a new Finnish 'Aromi' software. The following data collection and analyses will be carried out at the baseline and at the end of the intervention period: height, weight, waist and hip circumferences body composition by bioelectrical impedance analysis resting blood pressure fasting lipid profile in the plasma (total cholesterol, LDL and HDL, triglycerides) fasting glucose and insulin, HbA1c in the blood high sensitive C-reactive protein markers for nutritional status in plasma/serum: hemoglobin, transferrin receptor, ferritin, vitamin B12, folate, vitamin D urea/nitrogen in the urine total and heme-based N-nitroso compounds in feces, concentrations of bile acids, gut microbiota

Tracking Information

NCT #
NCT04599920
Collaborators
Not Provided
Investigators
Principal Investigator: Anne-Maria Pajari, PhD University of Helsinki