Clinical trial NCT05885750: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolism
Gut Microbiota
Inflammation
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover trial with two one-week wash-out periods in-between three interventions
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Metabolomics
timeFrame: one week between the start and end of each intervention
measure: Transcriptomics
timeFrame: one week between the start and end of each intervention
measure: Metagenomics
timeFrame: one week between the start and end of each intervention
measure: Inflammation status by inflammatory cytokines
timeFrame: one week between the start and end of each intervention
measure: Inflammation status by high-sensitive CRP
timeFrame: one week between the start and end of each intervention
Secondary outcomes:
measure: Glucose homeostasis
timeFrame: one week between the start and end of each intervention
measure: Lipid homeostasis
timeFrame: one week between the start and end of each intervention
measure: Body weight
timeFrame: five weeks (baseline and at the end of the complete study / after three interventions and 2 wash-outs)
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Food Sciences Unit, Department of Life Technologies, Faculty of Technology, University of Turku
Study officials:
affiliation: University of Turku
name: Kati Hanhineva, PhD
role: PRINCIPAL_INVESTIGATOR
References: