MetabolismNCT05885750
The Impact of Plant-Based Protein-rich Food Products With Varying Degree of Processing on the Human Gut Microbiome Composition and Human Metabolome
A study testing Unprocessed, Mildly processed and Heavily refined in people with Metabolism and Gut Microbiota, run by University of Turku at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism, Gut Microbiota, Inflammation
- What is being tested?
- Unprocessed, Mildly processed and Heavily refined
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFinland
- Study dates
- 5 Apr 2023to 19 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willingness to participate
- 18-65-years olf
- BMI 18.5-27 kg/m2
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Finland1 site
Food Sciences Unit, Department of Life Technologies, Faculty of Technology, University of Turku
Turku
About this study
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
Read the 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
- Being tested
- Unprocessed, Mildly processed, Heavily refined
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UnprocessedBehavioural
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 processedBehavioural
Participants will consume mildly processed commercially available plant-based protein-rich foods as meat replacement in their normal diet for one week.
Heavily refinedBehavioural
Participants will consume heavily refined processed commercially available plant-based protein-rich foods as meat replacement in their normal diet for one week.
| Study group | Role | What they receive |
|---|---|---|
| Diet 1 | Experimental | Unprocessed or minimally processed plant-based protein-rich food products Receives: Behavioral: Unprocessed |
| Diet 2 | Experimental | Mildly processed plant-based protein-rich food products Receives: Behavioral: Mildly processed |
| Diet 3 | Experimental | Heavily refined plant-based protein-rich food products Receives: Behavioral: Heavily refined |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomics
The changes in metabolism evoked by the interventions
Measured: one week between the start and end of each intervention
Transcriptomics
The changes in endogenous gene expression on RNA level
Measured: one week between the start and end of each intervention
Metagenomics
The alterations in the composition of gut microbiota
Measured: one week between the start and end of each intervention
Inflammation status by inflammatory cytokines
The changes in inflammatory cytokines
Measured: 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
Measured: one week between the start and end of each intervention
Secondary outcomes (3)
Glucose homeostasis
Fasting plasma glucose and insulin concentrations by clinical biochemistry analyses
Measured: one week between the start and end of each intervention
Lipid homeostasis
Cholesterol and triglyceride concentrations by clinical biochemistry analyses
Measured: one week between the start and end of each intervention
Body weight
Body weight in kilograms measured by standard weight scale
Measured: five weeks (baseline and at the end of the complete study / after three interventions and 2 wash-outs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start5 Apr 2023
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover trial with two one-week wash-out periods in-between three interventions
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marko Kalliomäki, MD, University of Turku
- Investigators
- Kati Hanhineva, PhD, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885750
- Sponsor's protocol ID
- Newplant
- Status last verified
- Jun 2023
- First submitted
- 17 May 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Plant-Based Protein-rich Food Products With Varying Degree of Processing on the Human Gut Microbiome Composition and Human Metabolome
- ClinicalTrials.gov ID
- NCT05885750
- Acronym / sponsor ID
- Newplant
- Conditions
- Metabolism, Gut Microbiota, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Crossover trial with two one-week wash-out periods in-between three interventions
| Arm | Type | Receives |
|---|---|---|
| Diet 1 | Experimental | Behavioral: UnprocessedUnprocessed or minimally processed plant-based protein-rich food products |
| Diet 2 | Experimental | Behavioral: Mildly processedMildly processed plant-based protein-rich food products |
| Diet 3 | Experimental | Behavioral: Heavily refinedHeavily refined plant-based protein-rich food products |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willingness to participate
- 18-65-years olf
- BMI 18.5-27 kg/m2
Key exclusion criteria (7 listed)
- Chronic disease with continuous medication
- Antibiotic use in the past 6 months
- Active smoker
- Gluten-free or vegan diet
- Pregnancy, lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UnprocessedParticipants will consume unprocessed or minimally processed commercially available plant-based protein-rich foods as meat replacement in their normal diet for one week. | Behavioural | Diet 1 |
| Mildly processedParticipants will consume mildly processed commercially available plant-based protein-rich foods as meat replacement in their normal diet for one week. | Behavioural | Diet 2 |
| Heavily refinedParticipants will consume heavily refined processed commercially available plant-based protein-rich foods as meat replacement in their normal diet for one week. | Behavioural | Diet 3 |
Primary outcome
Metabolomics
Time frame: one week between the start and end of each intervention
The changes in metabolism evoked by the interventions
Transcriptomics
Time frame: one week between the start and end of each intervention
The changes in endogenous gene expression on RNA level
Metagenomics
Time frame: one week between the start and end of each intervention
The alterations in the composition of gut microbiota
Inflammation status by inflammatory cytokines
Time frame: one week between the start and end of each intervention
The changes in inflammatory cytokines
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
3 secondary outcomes
Glucose homeostasis
Time frame: one week between the start and end of each intervention
Lipid homeostasis
Time frame: one week between the start and end of each intervention
Body weight
Time frame: five weeks (baseline and at the end of the complete study / after three interventions and 2 wash-outs)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kati Hanhineva, PhD principal investigator
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unprocessed, Mildly processed and Heavily refined in people with Metabolism and Gut Microbiota, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomics (time frame: one week between the start and end of each intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.