Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Type2 Diabetes | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Partial replacement of red meat with legume-based foods | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Red meat supplementation providing 25% of protein intake
- description
- A diet supplemented with 760 g of cooked and boneless red meat per week, corresponding the average consumption of red meat in Finnish men.
- interventionNames
- Dietary Supplement: Partial replacement of red meat with legume-based foods
- type
- EXPERIMENTAL
- label
- Red meat mostly replaced with legume-based foods
- description
- 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.
- interventionNames
- Dietary Supplement: Partial replacement of red meat with legume-based foods
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy * Omnivorous * No exclusion criteria listed below Exclusion Criteria: * 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
References
Publications (3)
- DERIVEDPietila TK, Cantini E, Itkonen ST, Salonen A, Pajari AM. Replacing red meat with non-soy legumes alters choline metabolites but not systemic inflammation or proxies of gut barrier function in healthy males in a 6-week RCT. J Nutr Biochem. 2026 Aug;154:110355. doi: 10.1016/j.jnutbio.2026.110355. Epub 2026 Mar 27. PMID 41905546
- DERIVEDBack 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
- DERIVEDItkonen 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