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

NCT04599920 | Unknown

• 1 other identifier: Leg4Life-HY
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Cardiovascular Diseases; Type2 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Changes in the composition of gut microbiota as a measure of modification of dietary protein composition.

  The composition of gut microbiota is measured using HITChip phylogenetic microarray.

  6 weeks

• Changes in the concentrations of plasma lipids as a measure of diet modification.

  The changes in the concentrations of total, LDL, and HDL cholesterol as well as plasma triglycerides.

  6 weeks

• Changes in the intake of nutrients and nutritional status of participants as a measure of diet modification.

  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.

  6 weeks

Secondary Outcomes (1)

• Changes in the concentrations of N-nitroso compounds in feces.

  6 weeks

Study Arms (2)

Red meat supplementation providing 25% of protein intake

ACTIVE COMPARATOR

A diet supplemented with 760 g of cooked and boneless red meat per week, corresponding the average consumption of red meat in Finnish men.

Dietary Supplement: Partial replacement of red meat with legume-based foods

Red meat mostly replaced with legume-based foods

EXPERIMENTAL

A diet supplemented with legume-based foods providing 20% of protein intake and with 200 g per week of red meat providing 5% of protein intake.

Dietary Supplement: Partial replacement of red meat with legume-based foods

Interventions

Partial replacement of red meat with legume-based foods DIETARY_SUPPLEMENT

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

Red meat mostly replaced with legume-based foods; Red meat supplementation providing 25% of protein intake

Eligibility Criteria

• Age: 20 Years - 65 Years
• Gender Eligibility Details: Red meat consumption exceeds the recommendation in 76% of Finnish men, while only 26% of Finnish women eat red meat more than the recommended maximum of 500 g per week. Decreasing meat consumption and replacing meat with legumes would be particularly important and relevant in men.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy
• Omnivorous

You may not qualify if:

• Vegan
• 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

Sponsors & Collaborators

• University of Helsinki: lead

Study Sites (1)

Department of Food and Nutrition, University of Helsinki

Helsinki, Finland

Location

Related Publications (2)

• Back S, Paivarinta E, Pellinen T, Itkonen ST, Lehtovirta M, Erkkola M, Kaartinen NE, Mannisto S, Pajari AM. Nutritional and health benefits of a partial substitution of red and processed meat with non-soy legumes: a 6-week randomized controlled trial in healthy working-age men. Eur J Nutr. 2025 Aug 19;64(6):259. doi: 10.1007/s00394-025-03783-x.

  PMID: 40828321 DERIVED

• Itkonen ST, Karhu P, Pellinen T, Lehtovirta M, Kaartinen NE, Mannisto S, Paivarinta E, Pajari AM. Effects of partial replacement of red and processed meat with non-soya legumes on bone and mineral metabolism and amino acid intakes in BeanMan randomised clinical trial. Br J Nutr. 2024 Jan 14;131(1):82-91. doi: 10.1017/S0007114523001514. Epub 2023 Jul 10.

  PMID: 37424311 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Anne-Maria Pajari, PhD

  University of Helsinki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: September 25, 2020
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)