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

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ClinicalTrials.gov Identifier: NCT03206827
Recruitment Status : Active, not recruiting
First Posted : July 2, 2017
Last Update Posted : August 13, 2019
Sponsor:
Collaborators:
Natural Resources Institute Finland
Makery Ltd, Finland
Information provided by (Responsible Party):
Anne-Maria Pajari, Helsinki University

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Type2 Diabetes Other: 70% animal, 30% plant proteins in diet Other: 50% animal, 50% plant proteins in diet Other: 30% animal, 70% plant proteins in diet Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Dietary Plant and Animal Proteins on Biomarkers of Colorectal Cancer and Type 2 Diabetes in Healthy Adults
Actual Study Start Date : November 29, 2016
Actual Primary Completion Date : June 30, 2017
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Other: 70% 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).

Experimental: 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).
Other: 50% 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).

Experimental: 30% animal, 70% plant proteins in diet
Dietary proteins from animal sources 30% and from plant sources 70%.
Other: 30% 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).




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Changes in the concentrations of metabolites derived from plant and animal-based foods in fecal water and urine [ Time Frame: 12 weeks ]
    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.

  2. Genotoxicity testing of human fecal water in 2D and 3D cell cultures [ Time Frame: 12 weeks ]
    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.



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Ages Eligible for Study:   20 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03206827


Sponsors and Collaborators
Helsinki University
Natural Resources Institute Finland
Makery Ltd, Finland
Investigators
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Principal Investigator: Anne-Maria Pajari, PhD Helsinki University

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Responsible Party: Anne-Maria Pajari, Adjunct Professor, Helsinki University
ClinicalTrials.gov Identifier: NCT03206827     History of Changes
Other Study ID Numbers: ScenoProt-HY
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anne-Maria Pajari, Helsinki University:
colorectal cancer
type 2 diabetes
diet
plant protein
animal protein

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases