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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05885750
Enrollment
38
Registered
2023-06-02
Start date
2023-04-05
Completion date
2023-12-19
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Microbiota, Inflammation, Metabolism

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.

Interventions

BEHAVIORALUnprocessed

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

BEHAVIORALMildly processed

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

BEHAVIORALHeavily refined

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

Sponsors

University of Turku
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention model description

Crossover trial with two one-week wash-out periods in-between three interventions

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Metabolomicsone week between the start and end of each interventionThe changes in metabolism evoked by the interventions
Transcriptomicsone week between the start and end of each interventionThe changes in endogenous gene expression on RNA level
Metagenomicsone week between the start and end of each interventionThe alterations in the composition of gut microbiota
Inflammation status by inflammatory cytokinesone week between the start and end of each interventionThe changes in inflammatory cytokines
Inflammation status by high-sensitive CRPone week between the start and end of each interventionThe changes in high-sensitive CRP by clinical biochemistry analysis

Secondary

MeasureTime frameDescription
Glucose homeostasisone week between the start and end of each interventionFasting plasma glucose and insulin concentrations by clinical biochemistry analyses
Lipid homeostasisone week between the start and end of each interventionCholesterol and triglyceride concentrations by clinical biochemistry analyses
Body weightfive 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

Countries

Finland

Contacts

PRINCIPAL_INVESTIGATORKati Hanhineva, PhD

University of Turku

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026