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

Study Overview

• Status: Completed
• Conditions: Inflammation; Gut Microbiota; Metabolism
• Intervention / Treatment: Behavioral: Unprocessed; Behavioral: Mildly processed; Behavioral: Heavily refined

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diet 1; Unprocessed or minimally processed plant-based protein-rich food products	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.
Experimental: Diet 2; Mildly processed plant-based protein-rich food products	Behavioral: Mildly processed; Participants will consume mildly processed commercially available plant-based protein-rich foods as meat replacement in their normal diet for one week.
Experimental: Diet 3; Heavily refined plant-based protein-rich food products	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transcriptomics	The changes in endogenous gene expression on RNA level	one week between the start and end of each intervention
Metabolomics	The changes in metabolism evoked by the interventions	one week between the start and end of each intervention
Metagenomics	The alterations in the composition of gut microbiota	one week between the start and end of each intervention
Inflammation status by inflammatory cytokines	The changes in inflammatory cytokines	one week between the start and end of each intervention
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose homeostasis	Fasting plasma glucose and insulin concentrations by clinical biochemistry analyses	one week between the start and end of each intervention
Lipid homeostasis	Cholesterol and triglyceride concentrations by clinical biochemistry analyses	one week between the start and end of each intervention
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)

Collaborators and Investigators

• Sponsor: University of Turku
• Investigators: Principal Investigator: Kati Hanhineva, PhD, University of Turku

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2023
• Primary Completion (Actual): December 19, 2023
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation; Diagnostic Techniques and Procedures; Diagnosis; Circulatory and Respiratory Physiological Phenomena; Diagnostic Techniques, Respiratory System; Respiratory Physiological Phenomena; Respiratory Function Tests; Airway Resistance
• Other Study ID Numbers: Newplant

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No