Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04599920 |
| Other study ID # |
Leg4Life-HY |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 25, 2020 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
May 2022 |
| Source |
University of Helsinki |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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
