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

University of Turku

Status: Enrolling

Conditions: Metabolism; Inflammation; Gut Microbiota

Treatments: Behavioral: Mildly processed; Behavioral: Heavily refined; Behavioral: Unprocessed

Study type: Interventional

Funder types: Other

Identifiers

NCT05885750

Newplant

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 3 patient groups

Diet 1

Experimental group

Description:

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

Treatment:

Behavioral: Unprocessed

Diet 2

Experimental group

Description:

Mildly processed plant-based protein-rich food products

Treatment:

Behavioral: Mildly processed

Diet 3

Experimental group

Description:

Heavily refined plant-based protein-rich food products

Treatment:

Behavioral: Heavily refined