The Impact of Plant-Based Protein-rich Food Products With Varying Degree of Processing on the Human Gut Microbiome Composition and Human Metabolome
Primary Purpose
Metabolism, Gut Microbiota, Inflammation
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Unprocessed
Mildly processed
Heavily refined
Sponsored by
About this trial
This is an interventional other trial for Metabolism
Eligibility Criteria
Inclusion Criteria: Willingness to participate 18-65-years olf BMI 18.5-27 kg/m2 Exclusion Criteria: Chronic disease with continuous medication Antibiotic use in the past 6 months Active smoker Gluten-free or vegan diet Pregnancy, lactation Abnormal thyroid, liver, or kidney function Low hemoglobin
Sites / Locations
- Food Sciences Unit, Department of Life Technologies, Faculty of Technology, University of TurkuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Diet 1
Diet 2
Diet 3
Arm Description
Unprocessed or minimally processed plant-based protein-rich food products
Mildly processed plant-based protein-rich food products
Heavily refined plant-based protein-rich food products
Outcomes
Primary Outcome Measures
Metabolomics
The changes in metabolism evoked by the interventions
Transcriptomics
The changes in endogenous gene expression on RNA level
Metagenomics
The alterations in the composition of gut microbiota
Inflammation status by inflammatory cytokines
The changes in inflammatory cytokines
Inflammation status by high-sensitive CRP
The changes in high-sensitive CRP by clinical biochemistry analysis
Secondary Outcome Measures
Glucose homeostasis
Fasting plasma glucose and insulin concentrations by clinical biochemistry analyses
Lipid homeostasis
Cholesterol and triglyceride concentrations by clinical biochemistry analyses
Body weight
Body weight in kilograms measured by standard weight scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05885750
Brief Title
The Impact of Plant-Based Protein-rich Food Products With Varying Degree of Processing on the Human Gut Microbiome Composition and Human Metabolome
Official Title
The Impact of Plant-Based Protein-rich Food Products With Varying Degree of Processing on the Human Gut Microbiome Composition and Human Metabolome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turku
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
It is observed that replacing meat with protein-rich plant-based food products are associated with lower mortality and obesity prevention. Sources of plant proteins typically undergo several processing and refinement procedures to improve the taste and digestibility of plant-based food products. These procedures alter the chemical composition, which can impact the nutritional quality of the processed food. It is not known what is the impact of processed products on human metabolism and intestinal microbiota. Therefore, the impact of a set of plant-based protein-rich food products with varying degree of processing on the composition and function of human gut microbiome and metabolism will be assessed in a clinical intervention
Detailed Description
Plant-based diets are known to have beneficial effects on both the environment and human health. Replacing animal protein with plant protein reduces overall mortality risk, and replacing meat with legumes and other sources of plant protein can lower the risk of chronic diseases such as type 2 diabetes and cardiovascular disease. However, the benefits of plant protein products is not evident. In order to make plant protein products more palatable and digestible, plant raw materials may go through several processing and refinement procedures. Typically, during these phases, carbohydrate fractions (e.g. dietary fiber) are removed from the plant material, which results in the loss of micronutrients as well as secondary plant metabolites with potentially health effects (e.g. polyphenolic compounds). Salt and various fats are added to some products, which can reduce the nutritional quality of the product. Subsequently, not all plant-based protein-rich foods are automatically healthy as there may be significant differences in the nutritional quality of the processed products, depending on the food processing utilized. Only little research information is available on the effects of processed plant protein products on human metabolism and intestinal microbiota. Therefore, this cross-over clinical intervention will be conducted with 38 healthy participants to investigate the impact of a set of plant-based protein-rich food products with varying degree of processing on the composition and function of human gut microbiome and metabolism will be assessed in a clinical intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism, Gut Microbiota, Inflammation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover trial with two one-week wash-out periods in-between three interventions
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diet 1
Arm Type
Experimental
Arm Description
Unprocessed or minimally processed plant-based protein-rich food products
Arm Title
Diet 2
Arm Type
Experimental
Arm Description
Mildly processed plant-based protein-rich food products
Arm Title
Diet 3
Arm Type
Experimental
Arm Description
Heavily refined plant-based protein-rich food products
Intervention Type
Behavioral
Intervention Name(s)
Unprocessed
Intervention Description
Participants will consume unprocessed or minimally processed commercially available plant-based protein-rich foods as meat replacement in their normal diet for one week.
Intervention Type
Behavioral
Intervention Name(s)
Mildly processed
Intervention Description
Participants will consume mildly processed commercially available plant-based protein-rich foods as meat replacement in their normal diet for one week.
Intervention Type
Behavioral
Intervention Name(s)
Heavily refined
Intervention Description
Participants will consume heavily refined processed commercially available plant-based protein-rich foods as meat replacement in their normal diet for one week.
Primary Outcome Measure Information:
Title
Metabolomics
Description
The changes in metabolism evoked by the interventions
Time Frame
one week between the start and end of each intervention
Title
Transcriptomics
Description
The changes in endogenous gene expression on RNA level
Time Frame
one week between the start and end of each intervention
Title
Metagenomics
Description
The alterations in the composition of gut microbiota
Time Frame
one week between the start and end of each intervention
Title
Inflammation status by inflammatory cytokines
Description
The changes in inflammatory cytokines
Time Frame
one week between the start and end of each intervention
Title
Inflammation status by high-sensitive CRP
Description
The changes in high-sensitive CRP by clinical biochemistry analysis
Time Frame
one week between the start and end of each intervention
Secondary Outcome Measure Information:
Title
Glucose homeostasis
Description
Fasting plasma glucose and insulin concentrations by clinical biochemistry analyses
Time Frame
one week between the start and end of each intervention
Title
Lipid homeostasis
Description
Cholesterol and triglyceride concentrations by clinical biochemistry analyses
Time Frame
one week between the start and end of each intervention
Title
Body weight
Description
Body weight in kilograms measured by standard weight scale
Time Frame
five weeks (baseline and at the end of the complete study / after three interventions and 2 wash-outs)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Willingness to participate
18-65-years olf
BMI 18.5-27 kg/m2
Exclusion Criteria:
Chronic disease with continuous medication
Antibiotic use in the past 6 months
Active smoker
Gluten-free or vegan diet
Pregnancy, lactation
Abnormal thyroid, liver, or kidney function
Low hemoglobin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veera Houttu, PhD
Phone
+358504627287
Email
veera.houttu@utu.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Kaisa Linderborg, PhD
Phone
+358294502472
Ext
+358504395535
Email
kaisa.linderborg@utu.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kati Hanhineva, PhD
Organizational Affiliation
University of Turku
Official's Role
Principal Investigator
Facility Information:
Facility Name
Food Sciences Unit, Department of Life Technologies, Faculty of Technology, University of Turku
City
Turku
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kati Hanhineva, PhD
Phone
+358294504044
Email
kati.hanhineva@utu.fi
First Name & Middle Initial & Last Name & Degree
Veera Houttu, PhD
First Name & Middle Initial & Last Name & Degree
Kaisa Linderborg, PhD
First Name & Middle Initial & Last Name & Degree
Kati Hanhineva, PhD
First Name & Middle Initial & Last Name & Degree
Marko Kalliomäki, PhD
12. IPD Sharing Statement
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The Impact of Plant-Based Protein-rich Food Products With Varying Degree of Processing on the Human Gut Microbiome Composition and Human Metabolome
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