Metabolic Cardiovascular SyndromeFermDiHealthNCT06587958
Fermented Plant-based Portfolio Diet 4 Metabolic Health
A study testing Fermented plant-based foods, Non-fermented plant-based foods and Habitual diet in people with Metabolic Cardiovascular Syndrome, run by Chalmers University of Technology at 1 site in Sweden.
Trial summary
The primary objective of this study is to evaluate the metabolic effects of a high-fiber portfolio diet based on fermented plant-based foods compared to a corresponding non-fermented plant-based diet and a control diet (habitual diet). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Metabolic Cardiovascular Syndrome
- What is being tested?
- Fermented plant-based foods, Non-fermented plant-based foods and Habitual diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteSweden
- Study dates
- 28 Oct 2024to 19 Dec 2025
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign of metabolic syndrome
- Waist circumference > 102 cm/88 cm M/W and at least one of the following:
- High density lipoprotein (HDL) ≤1.0 mmol/L men / HDL ≤1.3 mmol/L
- Triglycerides ≥ 1,7 mmol/L
- Blood pressure ≥130/85 mmHg
- Fasting glucose ≥5.6 mmol/L
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- Other inclusion criteria:
- Signed informed consent
- Willingness to consume the intervention foods
- Body mass index 25-35 kg/m2
- Hemoglobin 120-160 g/L
- Serum thyroid-stimulating hormone (S-TSH) <4 mIU/L
- Serum C-reactive protein (S-CRP) <5 mg/L
- Access to a -18⁰ C freezer
- Any medication stable for the last 14 days.
Who cannot join
- Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.
- Following any weight reduction program or having followed one during the last 6 months
- Food allergies or intolerances
- History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery, Helicobacter infection, Peptic ulcer disease, untreated celiac disease, etc.)
- Previous major gastrointestinal surgery
- Pregnant or lactating or wish to become pregnant during the period of the study.
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- Unable to understand written and spoken Swedish
- Lack of suitability for participation in the trial, for any reason, as judged by the medical doctor or PI.
- Pharmacological medication with drugs known to affect the microbiota, e.g., antibiotics, within 6 months prior to baseline.
- Intake of any probiotic pills or foods enriched in probiotics within 6 months prior to baseline.
- Type I diabetes
- Small bowel bacterial overgrowth
- Diarrheal disease
- Receiving pharmacological treatment for type II diabetes (treatments based on lifestyle interventions are acceptable, as long as it is compatible with the study protocol)
- Using nicotine products on a daily basis (including chewing gum, patches, snus etc.)
- History of heart failure or heart attack (TIA) within 1 year prior to screening
- Thyroid disorder
- Planned surgery within the next eight months
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital, Wallenberg Lab
Gothenburg, Ästra Götaland, 41346
About this study
Official title: Fermented Plant-based Portfolio Diet 4 Metabolic Health (FermDiHealth)
The primary objective of this study is to evaluate the metabolic effects of a high-fiber portfolio diet based on fermented plant-based foods compared to a corresponding non-fermented plant-based diet and a control diet (habitual diet). This will be assessed across gut microbiome profiles (high/low Prevotella), focusing on cardiometabolic risk factors, particularly inflammation.
A total of 100 men and women who meet all inclusion criteria and none of the exclusion criteria will be invited to participate. The study will employ a three-way randomized, controlled cross-over design, featuring six-week interventions separated by six-week washout periods. Participants will attend the clinic on 15 occasions, including screening visits.
- Conditions
- Metabolic Cardiovascular Syndrome
- Being tested
- Fermented plant-based foods, Non-fermented plant-based foods, Habitual diet
- 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 plant-based foodsDietary supplement
Participants will daily consume five different types of fermented plant-based foods, in addition to their habitual diet.
Non-fermented plant-based foodsDietary supplement
Participants will daily consume five different types of non-fermented plant-based foods, in addition to their habitual diet.
Habitual dietOther
Participants will follow their habitual diet.
| Study group | Role | What they receive |
|---|---|---|
| Fermented plant-based foods | Experimental | Not described Receives: Dietary Supplement: Fermented plant-based foods |
| Non-fermented plant-based foods | Active comparator | Not described Receives: Dietary Supplement: Non-fermented plant-based foods |
| Habitual diet | Other | Not described Receives: Other: Habitual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein
Investigate if c-reactive protein differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.
Measured: 6 weeks
Secondary outcomes (8)
Glucose
Investigate if glucose differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.
Measured: 6 weeks
Insulin
Investigate if insulin differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.
Measured: 6 weeks
Liver parameters
Investigate if liver parameters differ between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.
Measured: 6 weeks
Glycaemic variability
Investigate if glycaemic variability differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.
Measured: 2 weeks
Mixed meal tolerance test
Investigate if a mixed meal tolerance test causes different metabolic responses for the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet
Measured: 1-day
Gut microbiome
Investigate if the fecal microbiome differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.
Measured: 6 weeks
Blood pressure
Investigate if blood pressure differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.
Measured: 6 weeks
Blood lipid profile
Description: Investigate if c-reactive protein differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start28 Oct 2024
- Primary completion18 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Cardiovascular 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A three-way randomized controlled crossover study will investigate the effects of fermented plant-based foods, non-fermented plant-based foods and the habitual diet on cardiometabolic risk factors. Each intervention will be ongoing for six weeks with six weeks washout in-between. During the fermented/non-fermented plant-based foods intervention, participants will add several corresponding food products to their habitual diet. The study has been dimensioned based on the estimated effect on hsCRP.
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chalmers University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Göteborg University
- Responsible party
- Principal investigator, Rikard Landberg, Chalmers University of Technology
- Investigators
- Rikard Landberg, PhD, Principal investigator, Chalmers Univeristy of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587958
- Sponsor's protocol ID
- Chalmers-FermDiHealth
- Acronym
- FermDiHealth
- Status last verified
- Mar 2026
- First submitted
- 5 Sep 2024
- Last updated
- 19 Mar 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fermented Plant-based Portfolio Diet 4 Metabolic Health (FermDiHealth)
- ClinicalTrials.gov ID
- NCT06587958
- Acronym / sponsor ID
- FermDiHealth / Chalmers-FermDiHealth
- Conditions
- Metabolic Cardiovascular Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Chalmers University of TechnologyUniversity, hospital or other
- Collaborators
- KU Leuven, Göteborg University
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 19 Sep 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.
The primary objective of this study is to evaluate the metabolic effects of a high-fiber portfolio diet based on fermented plant-based foods compared to a corresponding non-fermented plant-based diet and a control diet (habitual diet). This will be assessed across gut microbiome profiles (high/low Prevotella), focusing on cardiometabolic risk factors, particularly inflammation.
A total of 100 men and women who meet all inclusion criteria and none of the exclusion criteria will be invited to participate. The study will employ a three-way randomized, controlled cross-over design, featuring six-week interventions separated by six-week washout periods. Participants will attend the clinic on 15 occasions, including screening visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A three-way randomized controlled crossover study will investigate the effects of fermented plant-based foods, non-fermented plant-based foods and the habitual diet on cardiometabolic risk factors. Each intervention will be ongoing for six weeks with six weeks washout in-between. During the fermented/non-fermented plant-based foods intervention, participants will add several corresponding food products to their habitual diet. The study has been dimensioned based on the estimated effect on hsCRP.
| Arm | Type | Receives |
|---|---|---|
| Fermented plant-based foods | Experimental | Dietary Supplement: Fermented plant-based foods |
| Non-fermented plant-based foods | Active comparator | Dietary Supplement: Non-fermented plant-based foods |
| Habitual diet | Other | Other: Habitual diet |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Sign of metabolic syndrome
- High density lipoprotein (HDL) ≤1.0 mmol/L men / HDL ≤1.3 mmol/L
- Triglycerides ≥ 1,7 mmol/L
- Blood pressure ≥130/85 mmHg
- Fasting glucose ≥5.6 mmol/L
Key exclusion criteria (18 listed)
- Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.
- Following any weight reduction program or having followed one during the last 6 months
- Food allergies or intolerances
- History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery, Helicobacter infection, Peptic ulcer disease, untreated celiac disease, etc.)
- Previous major gastrointestinal surgery
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 plant-based foodsParticipants will daily consume five different types of fermented plant-based foods, in addition to their habitual diet. | Dietary supplement | Fermented plant-based foods |
| Non-fermented plant-based foodsParticipants will daily consume five different types of non-fermented plant-based foods, in addition to their habitual diet. | Dietary supplement | Non-fermented plant-based foods |
| Habitual dietParticipants will follow their habitual diet. | Other | Habitual diet |
Primary outcome
C-reactive protein
Time frame: 6 weeks
Investigate if c-reactive protein differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.
8 secondary outcomes
Glucose
Time frame: 6 weeks
Insulin
Time frame: 6 weeks
Liver parameters
Time frame: 6 weeks
Glycaemic variability
Time frame: 2 weeks
Mixed meal tolerance test
Time frame: 1-day
Gut microbiome
Time frame: 6 weeks
Blood pressure
Time frame: 6 weeks
Blood lipid profile
Time frame: 6 weeks
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 19 Mar 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.
Rikard Landberg, PhD principal investigator
Chalmers Univeristy of Technology
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 plant-based foods, Non-fermented plant-based foods and Habitual diet in people with Metabolic Cardiovascular Syndrome, run by Chalmers University of Technology at 1 site in Sweden.
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 15 inclusion and 18 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 19 Mar 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 Sweden. 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?
C-reactive protein (time frame: 6 weeks). 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 19 Mar 2026.