Effects of Dietary Plant and Animal Proteins on Biomarkers of Colorectal Cancer and Type 2 Diabetes in Healthy Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Helsinki
- Enrollment
- 147
- Primary Endpoint
- Changes in the intake of nutrients and nutritional status of participants as a measure of diet modification
Study Overview
Brief Summary
The aim of this study is to investigate the effects of dietary plant and animal proteins on gut metabolism and markers for colorectal cancer as well as blood protein metabolites and markers for type 2 diabetes in healthy adults. The study participants will be stratified into three groups with different protein composition in diets: 1) animal 70%/plant 30%; 2) animal 50%/plant 50% and 3) animal 30%/plant 70%. The participants will get part of their diet as ready foods or raw material to promote their compliance. The participants will also get personal advice for their diets. Blood, stool and urine samples will be collected in the beginning and in the end of the 12 week intervention, as well as phenotype measures like BMI, blood pressure and body composition. The participants will also fill food diary before and in the end of the intervention.
Detailed Description
A human intervention study with healthy volunteers will be carried out to compare the effects of animal and plant-based protein sources on gut metabolism and markers for colorectal cancer as well as blood protein metabolites and markers for type 2 diabetes.
The study will be done in parallel-design, randomized fashion, with healthy human volunteers aged 20 - 69 years. Exclusion criteria will be as follows: strict vegan, regular user of fish oil or other food supplements, extreme sports, inflammatory bowel disease, colon irritable, celiac disease, continuous antibiotics or less than three months of the latest antibiotics use, type 2 diabetes and hormonal, liver or kidney disease. Duration of the intervention will be 12 weeks.
Intervention groups will be as follows (n=50/group):
Group 1: Dietary proteins from animal sources 70% and from plant sources 30%, representing an average Finnish diet consumed at the moment.
Group 2: Dietary proteins from animal sources 50% and from plant sources 50%, containing at most 500 g red meat/week (according to the current Finnish Nutrition Recommendations).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy, no
Exclusion Criteria
- •listed below.
- •Exclusion Criteria:
- •Strict vegan, food allergies, oral medication for any allergies, regular use of food supplements, extreme sports, inflammatory bowel disease, colon irritable, caeliac disease, any kind of cancer within 5 years, continuous antibiotics or less than three months of the latest antibiotics use, type 1 or 2 diabetes, hormonal, liver or kidney disease, pregnancy, lactation.
Arms & Interventions
70% animal, 30% plant proteins in diet
Dietary proteins from animal sources 70% and from plant sources 30%, representing an average Finnish diet consumed at the moment.
Intervention: 70% animal, 30% plant proteins in diet (Other)
50% animal, 50% plant proteins in diet
Dietary proteins from animal sources 50% and from plant sources 50%, containing at most 500 g red meat/week (according to the current Finnish Nutrition Recommendations).
Intervention: 50% animal, 50% plant proteins in diet (Other)
30% animal, 70% plant proteins in diet
Dietary proteins from animal sources 30% and from plant sources 70%.
Intervention: 30% animal, 70% plant proteins in diet (Other)
Outcomes
Primary Outcomes
Changes in the intake of nutrients and nutritional status of participants as a measure of diet modification
Time Frame: 12 weeks
The changes in the markers for nutritional status in the blood: vit. D25-OH, carotenoids, vitamin C and B12, ferritin, alkyl resorcinols. The intake of nutrients is calculated from 4-day food diaries.
Changes in the composition of gut microbiota and glucose metabolism as measures of modification of dietary protein composition
Time Frame: 12 weeks
The composition of gut microbiota is measured using HITChip phylogenetic microarray. Glucose tolerance test is carried out to analyze glucose metabolism in the beginning and in the end of the intervention.
Secondary Outcomes
- Changes in the concentrations of metabolites derived from plant and animal-based foods in fecal water and urine(12 weeks)
- Genotoxicity testing of human fecal water in 2D and 3D cell cultures(12 weeks)
Investigators
Anne-Maria Pajari
Adjunct Professor
University of Helsinki