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

Primary Purpose

Colorectal Cancer, Cardiovascular Diseases, Type2 Diabetes

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Partial replacement of red meat with legume-based foods
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring colorectal cancer, cardiovascular diseases, type2 diabetes, diet, plant protein, animal protein, red meat, legumes

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Food and Nutrition, University of Helsinki

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Red meat supplementation providing 25% of protein intake

Red meat mostly replaced with legume-based foods

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
October 19, 2020
Last Updated
May 17, 2022
Sponsor
University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT04599920
Brief Title
Effects of Replacing Red Meat With Legumes on Biomarkers of Chronic Diseases in Healthy Men (Leg4Life)
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Helsinki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Cardiovascular Diseases, Type2 Diabetes
Keywords
colorectal cancer, cardiovascular diseases, type2 diabetes, diet, plant protein, animal protein, red meat, legumes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Red meat supplementation providing 25% of protein intake
Arm Type
Active Comparator
Arm 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.
Arm Title
Red meat mostly replaced with legume-based foods
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Partial replacement of red meat with legume-based foods
Intervention Description
560 g of cooked and boneless red meat is replaced with legume-based foods providing the equal amount of protein.
Primary Outcome Measure Information:
Title
Changes in the composition of gut microbiota as a measure of modification of dietary protein composition.
Description
The composition of gut microbiota is measured using HITChip phylogenetic microarray.
Time Frame
6 weeks
Title
Changes in the concentrations of plasma lipids as a measure of diet modification.
Description
The changes in the concentrations of total, LDL, and HDL cholesterol as well as plasma triglycerides.
Time Frame
6 weeks
Title
Changes in the intake of nutrients and nutritional status of participants as a measure of diet modification.
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Changes in the concentrations of N-nitroso compounds in feces.
Description
The changes in gut microbiota are analyzed as a measure of diet modification.
Time Frame
6 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
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.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Maria Pajari, PhD
Organizational Affiliation
University of Helsinki
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Food and Nutrition, University of Helsinki
City
Helsinki
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data collected is confidential and cannot be shared.

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

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