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Effects of Replacing Red Meat With Legumes on Biomarkers of Chronic Diseases in Healthy Men (Leg4Life)

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04599920
Enrollment
100
Registered
2020-10-23
Start date
2020-09-25
Completion date
2023-12-31
Last updated
2022-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Colorectal Cancer, Type2 Diabetes

Keywords

colorectal cancer, cardiovascular diseases, type2 diabetes, diet, plant protein, animal protein, red meat, legumes

Brief summary

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.

Detailed 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 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. The investigators 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

Interventions

DIETARY_SUPPLEMENTPartial replacement of red meat with legume-based foods

560 g of cooked and boneless red meat is replaced with legume-based foods providing the equal amount of protein.

Sponsors

University of Helsinki
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy * Omnivorous * No

Exclusion criteria

listed below

Design outcomes

Primary

MeasureTime frameDescription
Changes in the composition of gut microbiota as a measure of modification of dietary protein composition.6 weeksThe composition of gut microbiota is measured using HITChip phylogenetic microarray.
Changes in the concentrations of plasma lipids as a measure of diet modification.6 weeksThe 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.6 weeksThe 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.

Secondary

MeasureTime frameDescription
Changes in the concentrations of N-nitroso compounds in feces.6 weeksThe changes in gut microbiota are analyzed as a measure of diet modification.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026