Colorectal CancerScenoProtNCT03206827
Effect of Plant and Animal Proteins on Biomarkers of Colorectal Cancer and Type 2 Diabetes in Healthy Adults (ScenoProt)
A study testing 70% animal, 30% plant proteins in diet, 50% animal, 50% plant proteins in diet and 30% animal, 70% plant proteins in diet in people with Colorectal Cancer and Type2 Diabetes, run by University of Helsinki.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Type2 Diabetes
- What is being tested?
- 70% animal, 30% plant proteins in diet, 50% animal, 50% plant proteins in diet and 30% animal, 70% plant proteins in diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- No sites listed yet
- Study dates
- 29 Nov 2016to 24 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, no exclusion criteria listed below.
Who cannot join
- 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.
About this study
Official title: Effects of Dietary Plant and Animal Proteins on Biomarkers of Colorectal Cancer and Type 2 Diabetes in Healthy Adults
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.
Read the 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.
- Conditions
- Colorectal Cancer, Type2 Diabetes
- Being tested
- 70% animal, 30% plant proteins in diet, 50% animal, 50% plant proteins in diet, 30% animal, 70% plant proteins in diet
- Keywords
- colorectal cancer, type 2 diabetes, diet, plant protein, animal protein
- Medical subject headings
- Colorectal Neoplasms, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
70% animal, 30% plant proteins in dietOther
Diet contains 70% of proteins from animal sources (beef, pork, chicken, dairy products, fish) and 30% from plant sources (bread and cereals).
50% animal, 50% plant proteins in dietOther
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).
30% animal, 70% plant proteins in dietOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 70% animal, 30% plant proteins in diet | Active comparator | Dietary proteins from animal sources 70% and from plant sources 30%, representing an average Finnish diet consumed at the moment. Receives: Other: 70% animal, 30% plant proteins in diet |
| 50% animal, 50% plant proteins in diet | Experimental | 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). Receives: Other: 50% animal, 50% plant proteins in diet |
| 30% animal, 70% plant proteins in diet | Experimental | Dietary proteins from animal sources 30% and from plant sources 70%. Receives: Other: 30% animal, 70% plant proteins in diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the composition of gut microbiota and glucose metabolism as measures of modification of dietary protein composition
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.
Measured: 12 weeks
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 the blood: vit. D25-OH, carotenoids, vitamin C and B12, ferritin, alkyl resorcinols. The intake of nutrients is calculated from 4-day food diaries.
Measured: 12 weeks
Secondary outcomes (2)
Changes in the concentrations of metabolites derived from plant and animal-based foods in fecal water and urine
Concentrations 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.
Measured: 12 weeks
Genotoxicity testing of human fecal water in 2D and 3D cell cultures
Fecal 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start29 Nov 2016
- Primary completion30 Jun 2017
- Study completion24 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Resources Institute Finland, Makery Ltd, Finland
- Responsible party
- Principal investigator, Anne-Maria Pajari, University of Helsinki
- Investigators
- Anne-Maria Pajari, PhD, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206827
- Sponsor's protocol ID
- ScenoProt-HY
- Acronym
- ScenoProt
- Status last verified
- Sep 2021
- First submitted
- 30 Jun 2017
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saarinen M, Pellinen T, Kostensalo J, Nousiainen J, Joensuu K, Itkonen ST, Pajari AM. Dietary climate impact correlates ambiguously with health biomarkers- a randomised controlled trial in healthy Finnish adults. Eur J Nutr. 2025 Feb 18;64(2):95. doi: 10.1007/s00394-025-03609-w.
PubMed 39964546Pellinen T, Paivarinta E, Isotalo J, Lehtovirta M, Itkonen ST, Korkalo L, Erkkola M, Pajari AM. Replacing dietary animal-source proteins with plant-source proteins changes dietary intake and status of vitamins and minerals in healthy adults: a 12-week randomized controlled trial. Eur J Nutr. 2022 Apr;61(3):1391-1404. doi: 10.1007/s00394-021-02729-3. Epub 2021 Nov 27.
PubMed 34837522Itkonen ST, Paivarinta E, Pellinen T, Viitakangas H, Risteli J, Erkkola M, Lamberg-Allardt C, Pajari AM. Partial Replacement of Animal Proteins with Plant Proteins for 12 Weeks Accelerates Bone Turnover Among Healthy Adults: A Randomized Clinical Trial. J Nutr. 2021 Jan 4;151(1):11-19. doi: 10.1093/jn/nxaa264.
PubMed 32939557
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Plant and Animal Proteins on Biomarkers of Colorectal Cancer and Type 2 Diabetes in Healthy Adults
- ClinicalTrials.gov ID
- NCT03206827
- Acronym / sponsor ID
- ScenoProt / ScenoProt-HY
- Conditions
- Colorectal Cancer, Type2 Diabetes
- Keywords
- colorectal cancer, type 2 diabetes, diet, plant protein, animal protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Natural Resources Institute Finland, Makery Ltd, Finland
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 70% animal, 30% plant proteins in diet | Active comparator | Other: 70% animal, 30% plant proteins in dietDietary proteins from animal sources 70% and from plant sources 30%, representing an average Finnish diet consumed at the moment. |
| 50% animal, 50% plant proteins in diet | Experimental | Other: 50% animal, 50% plant proteins in dietDietary 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). |
| 30% animal, 70% plant proteins in diet | Experimental | Other: 30% animal, 70% plant proteins in dietDietary proteins from animal sources 30% and from plant sources 70%. |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy, no exclusion criteria listed below.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 70% animal, 30% plant proteins in dietDiet contains 70% of proteins from animal sources (beef, pork, chicken, dairy products, fish) and 30% from plant sources (bread and cereals). | Other | 70% animal, 30% plant proteins in diet |
| 50% animal, 50% plant proteins in dietDiet 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). | Other | 50% animal, 50% plant proteins in diet |
| 30% animal, 70% plant proteins in dietDiet 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). | Other | 30% animal, 70% plant proteins in diet |
Primary outcome
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.
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.
2 secondary outcomes
Changes in the concentrations of metabolites derived from plant and animal-based foods in fecal water and urine
Time frame: 12 weeks
Genotoxicity testing of human fecal water in 2D and 3D cell cultures
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Derived from this study: PubMed 39964546Saarinen M, Pellinen T, Kostensalo J, Nousiainen J, Joensuu K, Itkonen ST, Pajari AM. Dietary climate impact correlates ambiguously with health biomarkers- a randomised controlled trial in healthy Finnish adults. Eur J Nutr. 2025 Feb 18;64(2):95. doi: 10.1007/s00394-025-03609-w.
- Derived from this study: PubMed 34837522Pellinen T, Paivarinta E, Isotalo J, Lehtovirta M, Itkonen ST, Korkalo L, Erkkola M, Pajari AM. Replacing dietary animal-source proteins with plant-source proteins changes dietary intake and status of vitamins and minerals in healthy adults: a 12-week randomized controlled trial. Eur J Nutr. 2022 Apr;61(3):1391-1404. doi: 10.1007/s00394-021-02729-3. Epub 2021 Nov 27.
- Derived from this study: PubMed 32939557Itkonen ST, Paivarinta E, Pellinen T, Viitakangas H, Risteli J, Erkkola M, Lamberg-Allardt C, Pajari AM. Partial Replacement of Animal Proteins with Plant Proteins for 12 Weeks Accelerates Bone Turnover Among Healthy Adults: A Randomized Clinical Trial. J Nutr. 2021 Jan 4;151(1):11-19. doi: 10.1093/jn/nxaa264.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Maria Pajari, PhD principal investigator
University of Helsinki
Questions about this trial
What is this clinical trial studying?
A study testing 70% animal, 30% plant proteins in diet, 50% animal, 50% plant proteins in diet and 30% animal, 70% plant proteins in diet in people with Colorectal Cancer and Type2 Diabetes, run by University of Helsinki.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the composition of gut microbiota and glucose metabolism as measures of modification of dietary protein composition (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03206827, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021; AzTrials last refreshed its copy on 8 Nov 2026.