Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04599920
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Anne-Maria Pajari, University of Helsinki

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Cardiovascular Diseases Type2 Diabetes Dietary Supplement: Partial replacement of red meat with legume-based foods Not Applicable

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. We 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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : September 25, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Red meat supplementation providing 25% of protein intake
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
560 g of cooked and boneless red meat is replaced with legume-based foods providing the equal amount of protein.

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Changes in the concentrations of N-nitroso compounds in feces. [ Time Frame: 6 weeks ]
    The changes in gut microbiota are analyzed as a measure of diet modification.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   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.
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04599920


Contacts
Layout table for location contacts
Contact: Anne-Maria Pajari, PhD +358294158203 anne-maria.pajari@helsinki.fi
Contact: Essi Päivärinta, PhD +358294158326 essi.paivarinta@helsinki.fi

Locations
Layout table for location information
Finland
Department of Food and Nutrition, University of Helsinki Recruiting
Helsinki, Finland
Contact: Anne-Maria Pajari, PhD    +358294158203    anne-maria.pajari@helsinki.fi   
Contact: Essi Päivärinta    +358294158326    essi.paivarinta@helsinki.fi   
Sponsors and Collaborators
University of Helsinki
Investigators
Layout table for investigator information
Principal Investigator: Anne-Maria Pajari, PhD University of Helsinki
Layout table for additonal information
Responsible Party: Anne-Maria Pajari, Adjunct Professor, University of Helsinki
ClinicalTrials.gov Identifier: NCT04599920    
Other Study ID Numbers: Leg4Life-HY
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data collected is confidential and cannot be shared.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anne-Maria Pajari, University of Helsinki:
colorectal cancer
cardiovascular diseases
type2 diabetes
diet
plant protein
animal protein
red meat
legumes
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases