Colorectal CancerNCT04599920
Effects of Replacing Red Meat With Legumes on Biomarkers of Chronic Diseases in Healthy Men (Leg4Life)
A study testing Partial replacement of red meat with legume-based foods in people with Colorectal Cancer and Cardiovascular Diseases, run by University of Helsinki at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Cardiovascular Diseases, Type2 Diabetes
- What is being tested?
- Partial replacement of red meat with legume-based foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 25 Sep 2020to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Omnivorous
- No exclusion criteria listed below
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Food and Nutrition, University of Helsinki
Helsinki
About this study
Official title: 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
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.
Read the 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
- Conditions
- Colorectal Cancer, Cardiovascular Diseases, Type2 Diabetes
- Being tested
- Partial replacement of red meat with legume-based foods
- Keywords
- colorectal cancer, cardiovascular diseases, type2 diabetes, diet, plant protein, animal protein, red meat, legumes
- Medical subject headings
- Colorectal Neoplasms, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial replacement of red meat with legume-based foodsDietary supplement
560 g of cooked and boneless red meat is replaced with legume-based foods providing the equal amount of protein.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Partial replacement of red meat with legume-based foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (1)
Changes in the concentrations of N-nitroso compounds in feces.
The changes in gut microbiota are analyzed as a measure of diet modification.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start25 Sep 2020
- Primary completionMar 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Maria Pajari, University of Helsinki
- Investigators
- Anne-Maria Pajari, PhD, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599920
- Sponsor's protocol ID
- Leg4Life-HY
- Status last verified
- May 2022
- First submitted
- 19 Oct 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data collected is confidential and cannot be shared.
Publications
Pietila 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.
PubMed 41905546Back 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.
PubMed 40828321Itkonen 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.
PubMed 37424311
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04599920
- Acronym / sponsor ID
- Leg4Life-HY
- Conditions
- Colorectal Cancer, Cardiovascular Diseases, Type2 Diabetes
- Keywords
- colorectal cancer, cardiovascular diseases, type2 diabetes, diet, plant protein, animal protein, red meat, legumes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red meat supplementation providing 25% of protein intake | Active comparator | Dietary Supplement: Partial replacement of red meat with legume-based foodsA diet supplemented with 760 g of cooked and boneless red meat per week, corresponding the average consumption of red meat in Finnish men. |
| Red meat mostly replaced with legume-based foods | Experimental | Dietary Supplement: Partial replacement of red meat with legume-based foodsA 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy
- Omnivorous
- No exclusion criteria listed below
Key exclusion criteria (15 listed)
- Vegan
- Food allergies against ingredients in foods supplemented in the study
- Oral medication for any allergies
- Regular use of food supplements
- Extreme sports
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial replacement of red meat with legume-based foods560 g of cooked and boneless red meat is replaced with legume-based foods providing the equal amount of protein. | Dietary supplement | Red meat mostly replaced with legume-based foods, Red meat supplementation providing 25% of protein intake |
Primary outcome
Changes in the composition of gut microbiota as a measure of modification of dietary protein composition.
Time frame: 6 weeks
The composition of gut microbiota is measured using HITChip phylogenetic microarray.
Changes in the concentrations of plasma lipids as a measure of diet modification.
Time frame: 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.
Time frame: 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.
1 secondary outcome
Changes in the concentrations of N-nitroso compounds in feces.
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 41905546Pietila 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.
- Derived from this study: PubMed 40828321Back 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.
- Derived from this study: PubMed 37424311Itkonen 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.
- Individual participant dataSharing planned: No. The data collected is confidential and cannot be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Maria Pajari, PhD principal investigator
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial replacement of red meat with legume-based foods in people with Colorectal Cancer and Cardiovascular Diseases, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the composition of gut microbiota as a measure of modification of dietary protein composition. (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04599920, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.