The Impact of Plant-Based Protein-rich Food Products With Varying Degree of Processing on the Human Gut Microbiome Composition and Human Metabolome

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05885750
• Other study ID #: Newplant
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: University of Turku
• Contact: Veera Houttu, PhD
• Phone: +358504627287
• Email: veera.houttu[@]utu.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gut Microbiota
• Inflammation
• Metabolism

Intervention

Behavioral:
• Unprocessed
Participants will consume unprocessed or minimally processed commercially available plant-based protein-rich foods as meat replacement in their normal diet for one week.
• Mildly processed
Participants will consume mildly processed commercially available plant-based protein-rich foods as meat replacement in their normal diet for one week.
• Heavily refined
Participants will consume heavily refined processed commercially available plant-based protein-rich foods as meat replacement in their normal diet for one week.

Locations

Country	Name	City	State
Finland	Food Sciences Unit, Department of Life Technologies, Faculty of Technology, University of Turku	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolomics	The changes in metabolism evoked by the interventions	one week between the start and end of each intervention
Primary	Transcriptomics	The changes in endogenous gene expression on RNA level	one week between the start and end of each intervention
Primary	Metagenomics	The alterations in the composition of gut microbiota	one week between the start and end of each intervention
Primary	Inflammation status by inflammatory cytokines	The changes in inflammatory cytokines	one week between the start and end of each intervention
Primary	Inflammation status by high-sensitive CRP	The changes in high-sensitive CRP by clinical biochemistry analysis	one week between the start and end of each intervention
Secondary	Glucose homeostasis	Fasting plasma glucose and insulin concentrations by clinical biochemistry analyses	one week between the start and end of each intervention
Secondary	Lipid homeostasis	Cholesterol and triglyceride concentrations by clinical biochemistry analyses	one week between the start and end of each intervention
Secondary	Body weight	Body weight in kilograms measured by standard weight scale	five weeks (baseline and at the end of the complete study / after three interventions and 2 wash-outs)