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NCT Number: NCT05885750

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

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

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Key information

Conditions

Metabolism Gut Microbiota Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Turku, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unprocessed

Behavioral

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

Behavioral

Participants will consume mildly processed commercially available plant-based protein-rich foods as meat replacement in their normal diet for one week.

Heavily refined

Behavioral

Participants will consume heavily refined processed commercially available plant-based protein-rich foods as meat replacement in their normal diet for one week.

Primary outcomes

  1. Metabolomics

    Time frame: one week between the start and end of each intervention

    The changes in metabolism evoked by the interventions

  2. Transcriptomics

    Time frame: one week between the start and end of each intervention

    The changes in endogenous gene expression on RNA level

  3. Metagenomics

    Time frame: one week between the start and end of each intervention

    The alterations in the composition of gut microbiota

  4. Inflammation status by inflammatory cytokines

    Time frame: one week between the start and end of each intervention

    The changes in inflammatory cytokines

  5. Inflammation status by high-sensitive CRP

    Time frame: one week between the start and end of each intervention

    The changes in high-sensitive CRP by clinical biochemistry analysis

Secondary outcomes

  1. Glucose homeostasis

    Time frame: one week between the start and end of each intervention

    Fasting plasma glucose and insulin concentrations by clinical biochemistry analyses

  2. Lipid homeostasis

    Time frame: one week between the start and end of each intervention

    Cholesterol and triglyceride concentrations by clinical biochemistry analyses

  3. Body weight

    Time frame: five 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

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2023
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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