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

NCT ID: NCT05885750

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-05
• Study Completion Date: 2024-12-31

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.

Conditions

Metabolism; Gut Microbiota; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Diet 1

Unprocessed or minimally processed plant-based protein-rich food products

Group Type: EXPERIMENTAL

Unprocessed

Intervention Type: 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.

Diet 2

Mildly processed plant-based protein-rich food products

Group Type: EXPERIMENTAL

Mildly processed

Intervention Type: BEHAVIORAL

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

Diet 3

Heavily refined plant-based protein-rich food products

Group Type: EXPERIMENTAL

Heavily refined

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Turku

OTHER

Sponsor Role: lead

Responsible Party

Marko Kalliomäki, MD

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kati Hanhineva, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Turku

Locations

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

Turku, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Veera Houttu, PhD

Role: CONTACT

veera.houttu@utu.fi

+358504627287

Kaisa Linderborg, PhD

Role: CONTACT

kaisa.linderborg@utu.fi

+358294502472 ext. +358504395535

Facility Contacts

Kati Hanhineva, PhD

Role: primary

kati.hanhineva@utu.fi

+358294504044

Other Identifiers

Newplant

Identifier Type: -

Identifier Source: org_study_id