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Effect of Plant and Animal Proteins on Biomarkers of Colorectal Cancer and Type 2 Diabetes in Healthy Adults (ScenoProt)

Effects of Dietary Plant and Animal Proteins on Biomarkers of Colorectal Cancer and Type 2 Diabetes in Healthy Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03206827
Acronym
ScenoProt
Enrollment
147
Registered
2017-07-02
Start date
2016-11-29
Completion date
2021-09-24
Last updated
2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Type2 Diabetes

Keywords

colorectal cancer, type 2 diabetes, diet, plant protein, animal protein

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). Group 3: Dietary proteins from animal sources 30% and from plant sources 70%. The intake of total protein will be kept at similar level compared to habitual, but intakes of fat and carbohydrates may vary as composing a diet with plant-based protein sources inevitably causes changes for example in dietary fibre intake. We will aim at controlling other potential dietary confounders to the extent that is possible in a whole-diet approach. This will ensure the feasibility of the diets and facilitate future applications in dietary practices at the population level. Before starting the intervention, the persons will get dietary advice how to fulfill their diets. They will get part of foods free to help to implement the diets and to enhance compliance. Blood, urine and fecal samples will be collected at the baseline (at the beginning of the intervention) and at the end of the intervention. Dietary intake and food consumption during the intervention will be followed by 3-day food records in the beginning and at the end of the intervention period. Nutrient intakes will be calculated using AIVO program. The following data collection and analyses will be carried out at the beginning and at the end of intervention: * height, weight, waist circumference * body composition by bioelectrical impedance analysis * resting blood pressure, hemoglobin * fasting lipid profile in the blood (total cholesterol, LDL and HDL, triglycerides) * fasting glucose and insulin, HbA1c in the blood * markers for low-grade inflammation in the blood: hs-CRP, cytokines such as IL-1beta, IL-6, IL-10 * protein metabolomics in the blood * markers of nutritional status in the bood: vit. D25-OH, carotenoids, vitamin C and B12, alkyl resorcinols * urea/nitrogen in the urine * measures of gut metabolism and risk markers for colorectal cancer: total N-nitroso compounds in the feces, plant-derived polyphenol metabolites in the feces, concentration of bile acids, cytotoxicity and genotoxicity assays of fecal water samples in 2D and 3D colon cancer cell cultures and gut microbiota analyses.

Interventions

OTHER70% animal, 30% plant proteins in diet

Diet contains 70% of proteins from animal sources (beef, pork, chicken, dairy products, fish) and 30% from plant sources (bread and cereals).

OTHER50% animal, 50% plant proteins in diet

Diet contains 50% of proteins from animal sources (beef, pork, chicken, dairy products, fish) and 50% from plant sources (bread and cereals, legumes, nuts, seeds, soy products).

OTHER30% animal, 70% plant proteins in diet

Diet contains 30% of proteins from animal sources (beef, pork, chicken, dairy products, fish) and 70% from plant sources (bread and cereals, legumes, nuts, seeds, soy products).

Sponsors

Natural Resources Institute Finland
CollaboratorOTHER_GOV
Makery Ltd, Finland
CollaboratorUNKNOWN
University of Helsinki
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 69 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy, no

Exclusion criteria

listed below.

Design outcomes

Primary

MeasureTime frameDescription
Changes in the composition of gut microbiota and glucose metabolism as measures of modification of dietary protein composition12 weeksThe 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.
Changes in the intake of nutrients and nutritional status of participants as a measure of diet modification12 weeksThe 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.

Secondary

MeasureTime frameDescription
Changes in the concentrations of metabolites derived from plant and animal-based foods in fecal water and urine12 weeksConcentrations of metabolites derived from plant-based foods in fecal water are measured using UPLC (ultra performance liquid chromatography). Concentrations of fecal nitroso compounds as a measure of red meat consumption is measured as apparent total nitroso compounds.
Genotoxicity testing of human fecal water in 2D and 3D cell cultures12 weeksFecal water is isolated from fecal samples collected in the beginning and in the end of intervention period. The samples are tested for markers of genotoxicity in 2D and 3D cell cultures.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026