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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

Not Applicable
Recruiting
Conditions
Gut Microbiota
Metabolism
Inflammation
Interventions
Behavioral: Unprocessed
Behavioral: Mildly processed
Behavioral: Heavily refined
Registration Number
NCT05885750
Lead Sponsor
University of Turku
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
38
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Diet 1UnprocessedUnprocessed or minimally processed plant-based protein-rich food products
Diet 2Mildly processedMildly processed plant-based protein-rich food products
Diet 3Heavily refinedHeavily refined plant-based protein-rich food products
Primary Outcome Measures
NameTimeMethod
Metabolomicsone week between the start and end of each intervention

The changes in metabolism evoked by the interventions

Transcriptomicsone week between the start and end of each intervention

The changes in endogenous gene expression on RNA level

Inflammation status by high-sensitive CRPone week between the start and end of each intervention

The changes in high-sensitive CRP by clinical biochemistry analysis

Metagenomicsone week between the start and end of each intervention

The alterations in the composition of gut microbiota

Inflammation status by inflammatory cytokinesone week between the start and end of each intervention

The changes in inflammatory cytokines

Secondary Outcome Measures
NameTimeMethod
Lipid homeostasisone week between the start and end of each intervention

Cholesterol and triglyceride concentrations by clinical biochemistry analyses

Body weightfive weeks (baseline and at the end of the complete study / after three interventions and 2 wash-outs)

Body weight in kilograms measured by standard weight scale

Glucose homeostasisone week between the start and end of each intervention

Fasting plasma glucose and insulin concentrations by clinical biochemistry analyses

Trial Locations

Locations (1)

Food Sciences Unit, Department of Life Technologies, Faculty of Technology, University of Turku

🇫🇮

Turku, Finland

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