Metabolic SyndromeNCT06393114
Impacts of Fermented Oat-based Product on Gut Microbiota and Health
A study testing Fermented oat-based product and Unfermented oat-based product in people with Metabolic Syndrome, run by University of Eastern Finland at 1 site in Finland.
Trial summary
This study aims to investigate the effects of consuming fermented oat-based products on gut and overall human health. It is a randomized, controlled, cross-over trial with a dietary intervention. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Fermented oat-based product and Unfermented oat-based product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteFinland
- Study dates
- 22 Jan 2024to 18 Dec 2024
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Waist circumference >90 cm (women) or >100 cm (men) OR BMI 26-38 kg/m2
- One of the following:
- raised blood pressure (systolic ≥ 130 mmHg and/or diastolic 85 mmHg)
- raised fasting plasma glucose (≥ 5.6 mmol/l)
- raised triglycerides (≥ 1.7 mmol/l)
- raised total cholesterol (≥ 5 mmol/l)
Show all 10Show fewer
- raised LDL (≥ 3 mmol/l)
- reduced HDL (women < 1.3 mmol/l, men 1.0 mmol/l)
- Use of cereal products and dairy products or their plant-based alternatives as a part of habitual diet
- Willingness to follow intervention diets for the whole study
Who cannot join
- Diagnosed chronic diseases and conditions which could hamper the adherence to the dietary intervention protocol, e.g., chronic liver, thyroid, kidney, or gastrointestinal diseases
- Pregnancy and lactation
- Gluten-free or vegan diet
- Recent use of antibiotics (within 3 months)
- Gastrointestinal surgery (within 6 months)
- Alcohol abuse (AUDIT ≥ 15 p and measures of liver function)
- regular smoking or use of snus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impacts of Fermented Plant-based Products High in Protein and Fibre on Gut Microbiota and Health: a Randomized, Controlled, Cross-over Trial
This study aims to investigate the effects of consuming fermented oat-based products on gut and overall human health. It is a randomized, controlled, cross-over trial with a dietary intervention.
A total of 100 participants will be enrolled in this study and they will eat both fermented and unfermented oat-based products for three weeks. Participants will eat their habitual diet between the dietary intervention periods (wash-out).
During the study, participants' perceived health, inflammatory markers, glucose and lipid metabolism, tryptophan metabolites, gastrointestinal symptoms, and gut microbiota will be assessed.
Read the detailed description
Plant-based protein sources, such as those derived from oats, are experiencing high demand due to their role in reducing reliance on animal products and promoting a more sustainable food system. Despite this, there is limited information available regarding the impact of components like fibre in plant-based foods on protein and other nutrients' metabolism.
Food fermentation emerges as a potential solution to enhance the absorption of plant-based protein and various nutrients in the small intestine. This is achieved by reducing antinutrients and facilitating the absorption process. Additionally, food fermentation has implications for the composition and metabolic activity of the gut microbiota, influencing metabolism, immune responses, intestinal function, and overall health. The metabolism of tryptophan in the gut, modulated by the gut microbiota and the production of various metabolites, may serve as a key link in these observed effects.
The fermentation of plant-based foods potentially enhances the beneficial health effects of these foods, and investigating this contributes to an increased understanding of the gut-mediated health effects of foods and the mechanisms behind them. This study will be part of a European research project HealthFerm.
Detailed objectives are to:
- compare fermented and unfermented plant-based food products to blood lipid and glucose metabolism and gastrointestinal comfort as well as perceived and observed overall well-being.
- study the effects of fermented and unfermented plant-based food consumption on the markers for gut permeability and inflammation.
- study the difference in microbiota composition and diversity after consuming fermented and unfermented plant-based foods and its contribution to cardiometabolic outcomes.
- study the difference in microbiota-related metabolites, especially tryptophan metabolites between fermented and unfermented plant-based foods.
A total of 100 participants will be enrolled in this randomized, controlled, cross-over trial, during which they will eat both fermented and unfermented oat-based products as part of their habitual diet. The study follows this sequence:
Weeks 1-3: Habitual diet Weeks 4-6: Dietary Intervention 1 Weeks 7-9: Habitual diet (wash-out) Weeks 10-12: Dietary Intervention 2
Blood, urinary and faecal samples, as well as food diaries and questionnaires, are collected at the end of each study period to assess participants' perceived health, inflammatory markers, glucose and lipid metabolism, tryptophan metabolites, gastrointestinal symptoms, and gut microbiota. In addition, participants' values and attitudes towards fermented foods are assessed. At the end of the study, participants will receive their laboratory results and dietary guidance for their habitual diet from a registered dietitian.
- Conditions
- Metabolic Syndrome
- Being tested
- Fermented oat-based product, Unfermented oat-based product
- Keywords
- Fermentation, Plant Proteins, Dietary, Inflammation Mediators, Gastrointestinal Microbiome, Tryptophan
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented oat-based productOther
Participants will incorporate a novel fermented product into their habitual diet for three weeks. In addition, the consumption of dairy and plant-based dairy alternatives is restricted. Cereal product consumption, specifically bread and porridge, is slightly restricted to prevent gastrointestinal symptoms caused by the increased intake of dietary fibre. Participants will receive dietary guidance on how to follow the intervention diet, as well as potential supplement recommendations provided by the authorized nutritionist.
Unfermented oat-based productOther
Participants will incorporate a novel unfermented product into their habitual diet for three weeks. Dietary adjustments and other guidance are consistent with those described during the fermented product intervention.
| Study group | Role | What they receive |
|---|---|---|
| Fermented product | Experimental | Participants will consume a fermented oat-based product daily for three weeks within their diet. Receives: Other: Fermented oat-based product |
| Unfermented product | Active comparator | Participants will consume an unfermented oat-based product daily for three weeks within their diet. Receives: Other: Unfermented oat-based product |
| Habitual diet | No intervention | Participants consume their habitual diet without any intervention products. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory marker 1
P-hs-CRP (mg/l)
Measured: Weeks 3, 6, 9, and 12
Inflammatory marker 2
IL-22
Measured: Weeks 3, 6, 9, and 12
Inflammatory marker 3
LBP (μg/ml)
Measured: Weeks 3, 6, 9, and 12
Secondary outcomes (10)
Changes in the composition gut microbiota
Composition of gut microbiota will be analysed from faecal samples
Measured: Weeks 3, 6, and 12
Glucose metabolism
fP-Gluk and B-HbA1C (mmol/l)
Measured: Weeks 3, 6, 9, and 12
Insulin response
fP-Insu (mU/l)
Measured: Weeks 3, 6, 9, and 12
Lipid metabolism
fP-Kol, fP-Kol-HDL, fP-Kol-LDL, fP-Trigly, and fP-FFA (mmol/l)
Measured: Weeks 3, 6, 9, and 12
Tryptophan metabolism
Tryptophan metabolites will be analysed with non-targeted metabolomics.
Measured: Weeks 3, 6, 9, and 12
Self-reported overall health
Short Form-36 Health Survey (SF-36). Different sections are rated from 0 to 100 points, where higher scores mean better perceived health.
Measured: Weeks 3, 6, 9, and 12
Self-reported mental health
General Health Questionnaire-12 (GHQ-12). The questionnaire is rated from 0 to 12 points, where higher score means greater psychological distress.
Measured: Weeks 3, 6, 9, and 12
Self-reported gut health
Gastrointestinal Symptoms Rating Scale (GSRS)
Measured: Weeks 3, 6, 9, and 12
Attitudes and values
Unvalidated questionnaire
Measured: Weeks 0 and 12
Opinions about the study products
Unvalidated questionnaire
Measured: Weeks 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start22 Jan 2024
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- During the run-in phase, participants consume their habitual diet. Subsequently, participants are randomized to incorporate one of the study products into their habitual diet for three weeks. The amount of the products to be consumed is 4-6 dl/day, with the precise amount being determined based on the participants' energy requirements. After the three-week diet period, participants will return to their habitual diet, followed by another three-week period during which they will consume the alternate intervention product. The overall duration of the study will be 12 weeks for each participant.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku, Umeå University, ETH Zurich, KU Leuven
- Responsible party
- Principal investigator, Marjukka Kolehmainen, University of Eastern Finland
- Investigators
- Marjukka Kolehmainen, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393114
- Sponsor's protocol ID
- HE 101060247
- Status last verified
- Jan 2025
- First submitted
- 2 Apr 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liikonen V, Cera S, Blontrock E, Lu J, Immonen M, Partanen R, Zehnder-Wyss O, Courtin CM, Gomez-Gallego C, Kaartinen NE, Langton M, Mikkonen S, Nystrom L, Tuccillo F, Vakevainen K, Wouters A, Katina K, Kolehmainen M. Role of bioprocessing in modifying cardiometabolic outcomes of an oat-based dairy alternative in a randomised controlled clinical intervention. Clin Nutr. 2026 Jul 29;64:106744. doi: 10.1016/j.clnu.2026.106744. Online ahead of print.
PubMed 42574785
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of Fermented Plant-based Products High in Protein and Fibre on Gut Microbiota and Health: a Randomized, Controlled, Cross-over Trial
- ClinicalTrials.gov ID
- NCT06393114
- Acronym / sponsor ID
- HE 101060247
- Conditions
- Metabolic Syndrome
- Keywords
- Fermentation, Plant Proteins, Dietary, Inflammation Mediators, Gastrointestinal Microbiome, Tryptophan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- University of Turku, Umeå University, ETH Zurich, KU Leuven
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 1 May 2024 (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.
This study aims to investigate the effects of consuming fermented oat-based products on gut and overall human health. It is a randomized, controlled, cross-over trial with a dietary intervention.
A total of 100 participants will be enrolled in this study and they will eat both fermented and unfermented oat-based products for three weeks. Participants will eat their habitual diet between the dietary intervention periods (wash-out).
During the study, participants' perceived health, inflammatory markers, glucose and lipid metabolism, tryptophan metabolites, gastrointestinal symptoms, and gut microbiota will be assessed.
Detailed description
Plant-based protein sources, such as those derived from oats, are experiencing high demand due to their role in reducing reliance on animal products and promoting a more sustainable food system. Despite this, there is limited information available regarding the impact of components like fibre in plant-based foods on protein and other nutrients' metabolism.
Food fermentation emerges as a potential solution to enhance the absorption of plant-based protein and various nutrients in the small intestine. This is achieved by reducing antinutrients and facilitating the absorption process. Additionally, food fermentation has implications for the composition and metabolic activity of the gut microbiota, influencing metabolism, immune responses, intestinal function, and overall health. The metabolism of tryptophan in the gut, modulated by the gut microbiota and the production of various metabolites, may serve as a key link in these observed effects.
The fermentation of plant-based foods potentially enhances the beneficial health effects of these foods, and investigating this contributes to an increased understanding of the gut-mediated health effects of foods and the mechanisms behind them. This study will be part of a European research project HealthFerm.
Detailed objectives are to:
- compare fermented and unfermented plant-based food products to blood lipid and glucose metabolism and gastrointestinal comfort as well as perceived and observed overall well-being.
- study the effects of fermented and unfermented plant-based food consumption on the markers for gut permeability and inflammation.
- study the difference in microbiota composition and diversity after consuming fermented and unfermented plant-based foods and its contribution to cardiometabolic outcomes.
- study the difference in microbiota-related metabolites, especially tryptophan metabolites between fermented and unfermented plant-based foods.
A total of 100 participants will be enrolled in this randomized, controlled, cross-over trial, during which they will eat both fermented and unfermented oat-based products as part of their habitual diet. The study follows this sequence:
Weeks 1-3: Habitual diet Weeks 4-6: Dietary Intervention 1 Weeks 7-9: Habitual diet (wash-out) Weeks 10-12: Dietary Intervention 2
Blood, urinary and faecal samples, as well as food diaries and questionnaires, are collected at the end of each study period to assess participants' perceived health, inflammatory markers, glucose and lipid metabolism, tryptophan metabolites, gastrointestinal symptoms, and gut microbiota. In addition, participants' values and attitudes towards fermented foods are assessed. At the end of the study, participants will receive their laboratory results and dietary guidance for their habitual diet from a registered dietitian.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- During the run-in phase, participants consume their habitual diet. Subsequently, participants are randomized to incorporate one of the study products into their habitual diet for three weeks. The amount of the products to be consumed is 4-6 dl/day, with the precise amount being determined based on the participants' energy requirements. After the three-week diet period, participants will return to their habitual diet, followed by another three-week period during which they will consume the alternate intervention product. The overall duration of the study will be 12 weeks for each participant.
| Arm | Type | Receives |
|---|---|---|
| Fermented product | Experimental | Other: Fermented oat-based productParticipants will consume a fermented oat-based product daily for three weeks within their diet. |
| Unfermented product | Active comparator | Other: Unfermented oat-based productParticipants will consume an unfermented oat-based product daily for three weeks within their diet. |
| Habitual diet | No intervention | –Participants consume their habitual diet without any intervention products. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Waist circumference >90 cm (women) or >100 cm (men) OR BMI 26-38 kg/m2
- One of the following:
- Use of cereal products and dairy products or their plant-based alternatives as a part of habitual diet
- Willingness to follow intervention diets for the whole study
Key exclusion criteria (7 listed)
- Diagnosed chronic diseases and conditions which could hamper the adherence to the dietary intervention protocol, e.g., chronic liver, thyroid, kidney, or gastrointestinal diseases
- Pregnancy and lactation
- Gluten-free or vegan diet
- Recent use of antibiotics (within 3 months)
- Gastrointestinal surgery (within 6 months)
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 |
|---|---|---|
| Fermented oat-based productParticipants will incorporate a novel fermented product into their habitual diet for three weeks. In addition, the consumption of dairy and plant-based dairy alternatives is restricted. Cereal product consumption, specifically bread and porridge, is slightly restricted to prevent gastrointestinal symptoms caused by the increased intake of dietary fibre. Participants will receive dietary guidance on how to follow the intervention diet, as well as potential supplement recommendations provided by the authorized nutritionist. | Other | Fermented product |
| Unfermented oat-based productParticipants will incorporate a novel unfermented product into their habitual diet for three weeks. Dietary adjustments and other guidance are consistent with those described during the fermented product intervention. | Other | Unfermented product |
Primary outcome
Inflammatory marker 1
Time frame: Weeks 3, 6, 9, and 12
P-hs-CRP (mg/l)
Inflammatory marker 2
Time frame: Weeks 3, 6, 9, and 12
IL-22
Inflammatory marker 3
Time frame: Weeks 3, 6, 9, and 12
LBP (μg/ml)
10 secondary outcomes
Changes in the composition gut microbiota
Time frame: Weeks 3, 6, and 12
Glucose metabolism
Time frame: Weeks 3, 6, 9, and 12
Insulin response
Time frame: Weeks 3, 6, 9, and 12
Lipid metabolism
Time frame: Weeks 3, 6, 9, and 12
Tryptophan metabolism
Time frame: Weeks 3, 6, 9, and 12
Self-reported overall health
Time frame: Weeks 3, 6, 9, and 12
Self-reported mental health
Time frame: Weeks 3, 6, 9, and 12
Self-reported gut health
Time frame: Weeks 3, 6, 9, and 12
Attitudes and values
Time frame: Weeks 0 and 12
Opinions about the study products
Time frame: Weeks 6 and 12
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 9 Jan 2025.
- Derived from this study: PubMed 42574785Liikonen V, Cera S, Blontrock E, Lu J, Immonen M, Partanen R, Zehnder-Wyss O, Courtin CM, Gomez-Gallego C, Kaartinen NE, Langton M, Mikkonen S, Nystrom L, Tuccillo F, Vakevainen K, Wouters A, Katina K, Kolehmainen M. Role of bioprocessing in modifying cardiometabolic outcomes of an oat-based dairy alternative in a randomised controlled clinical intervention. Clin Nutr. 2026 Jul 29;64:106744. doi: 10.1016/j.clnu.2026.106744. Online ahead of print.
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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.
Marjukka Kolehmainen principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented oat-based product and Unfermented oat-based product in people with Metabolic Syndrome, run by University of Eastern Finland 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 10 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 9 Jan 2025. 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?
Inflammatory marker 1 (time frame: Weeks 3, 6, 9, and 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06393114, which also lists 1 linked publication.
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 9 Jan 2025.