Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT04599920
Status:
UNKNOWN
Last Update Posted:
2022-05-18
First Post:
2020-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Replacing Red Meat With Legumes on Biomarkers of Chronic Diseases in Healthy Men (Leg4Life)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2020-10-19', 'studyFirstSubmitQcDate': '2020-10-19', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the composition of gut microbiota as a measure of modification of dietary protein composition.', 'timeFrame': '6 weeks', 'description': 'The composition of gut microbiota is measured using HITChip phylogenetic microarray.'}, {'measure': 'Changes in the concentrations of plasma lipids as a measure of diet modification.', 'timeFrame': '6 weeks', 'description': 'The changes in the concentrations of total, LDL, and HDL cholesterol as well as plasma triglycerides.'}, {'measure': 'Changes in the intake of nutrients and nutritional status of participants as a measure of diet modification.', 'timeFrame': '6 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Changes in the concentrations of N-nitroso compounds in feces.', 'timeFrame': '6 weeks', 'description': 'The changes in gut microbiota are analyzed as a measure of diet modification.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal cancer', 'cardiovascular diseases', 'type2 diabetes', 'diet', 'plant protein', 'animal protein', 'red meat', 'legumes'], 'conditions': ['Colorectal Cancer', 'Cardiovascular Diseases', 'Type2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '40828321', 'type': 'DERIVED', 'citation': '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': '37424311', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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.\n\nIntervention groups will be as follows (n=50/group):\n\nGroup 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.\n\nGroup 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.\n\nThe 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.\n\nBefore 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.\n\nBlood, 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.\n\nThe following data collection and analyses will be carried out at the baseline and at the end of the intervention period:\n\n* height, weight, waist and hip circumferences\n* body composition by bioelectrical impedance analysis\n* resting blood pressure\n* fasting lipid profile in the plasma (total cholesterol, LDL and HDL, triglycerides)\n* fasting glucose and insulin, HbA1c in the blood\n* high sensitive C-reactive protein\n* markers for nutritional status in plasma/serum: hemoglobin, transferrin receptor, ferritin, vitamin B12, folate, vitamin D\n* urea/nitrogen in the urine\n* total and heme-based N-nitroso compounds in feces, concentrations of bile acids, gut microbiota"}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Omnivorous\n* No exclusion criteria listed below\n\nExclusion Criteria:\n\n* Vegan\n* Food allergies against ingredients in foods supplemented in the study\n* Oral medication for any allergies\n* Regular use of food supplements\n* Extreme sports\n* Inflammatory bowel disease\n* Colon irritable\n* Coeliac disease\n* Any kind of cancer within 5 years\n* Continuous antibiotics or less than 3 months of the latest antibiotics use\n* Type 1 or 2 diabetes\n* Hypercholesterolemia\n* Hormonal, liver or kidney disease\n* Alcohol consumption more than 24 measures per week\n* Smoking, using snuff'}, 'identificationModule': {'nctId': 'NCT04599920', 'briefTitle': 'Effects of Replacing Red Meat With Legumes on Biomarkers of Chronic Diseases in Healthy Men (Leg4Life)', 'organization': {'class': 'OTHER', 'fullName': 'University of Helsinki'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Leg4Life-HY'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'Partial replacement of red meat with legume-based foods', 'type': 'DIETARY_SUPPLEMENT', 'description': '560 g of cooked and boneless red meat is replaced with legume-based foods providing the equal amount of protein.', 'armGroupLabels': ['Red meat mostly replaced with legume-based foods', 'Red meat supplementation providing 25% of protein intake']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'country': 'Finland', 'facility': 'Department of Food and Nutrition, University of Helsinki', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Anne-Maria Pajari, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Helsinki'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data collected is confidential and cannot be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Helsinki', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Professor', 'investigatorFullName': 'Anne-Maria Pajari', 'investigatorAffiliation': 'University of Helsinki'}}}}