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

NCT03206827 | Completed

• 1 other identifier: ScenoProt-HY
• Study Type: interventional
• Target: 147
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer; Type2 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 weeks

Secondary Outcomes (2)

• 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

Study Arms (3)

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.

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).

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%.

Other: 30% animal, 70% plant proteins in diet

Interventions

70% animal, 30% plant proteins in diet OTHER

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

70% animal, 30% plant proteins in diet

50% animal, 50% plant proteins in diet OTHER

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).

50% animal, 50% plant proteins in diet

30% animal, 70% plant proteins in diet OTHER

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).

30% animal, 70% plant proteins in diet

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Helsinki: lead
• Natural Resources Institute Finland: collaborator
• Makery Ltd, Finland: collaborator

Related Publications (3)

• 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.

  PMID: 39964546 DERIVED

• Pellinen 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.

  PMID: 34837522 DERIVED

• Itkonen 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.

  PMID: 32939557 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Diabetes Mellitus, Type 2

Interventions

Plant Proteins; Diet

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Anne-Maria Pajari, PhD

  University of Helsinki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 2, 2017
• Study Start: November 29, 2016
• Primary Completion: June 30, 2017
• Study Completion: September 24, 2021
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share