Dietary intervention using fermented plant-based foods for metabolic health
Fermented Plant-based Portfolio Diet 4 Metabolic Health (FermDiHealth)
NA · Chalmers University of Technology · NCT06587958
This study tests if eating a diet rich in fermented plant-based foods can improve metabolic health in people with metabolic syndrome compared to other types of diets.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Chalmers University of Technology (other) |
| Locations | 1 site (Gothenburg, ästra Götaland) |
| Trial ID | NCT06587958 on ClinicalTrials.gov |
What this trial studies
This study evaluates the metabolic effects of a high-fiber portfolio diet based on fermented plant-based foods compared to a non-fermented plant-based diet and a habitual diet. It employs a three-way randomized, controlled cross-over design with 100 participants who meet specific criteria for metabolic syndrome. Each participant will undergo six-week interventions followed by six-week washout periods, with assessments focusing on gut microbiome profiles and cardiometabolic risk factors, particularly inflammation.
Who should consider this trial
Good fit: Ideal candidates are adults with signs of metabolic syndrome, including specific waist circumference and blood marker thresholds.
Not a fit: Patients with significant gastrointestinal conditions or food allergies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary approach to improve metabolic health and reduce cardiovascular risk factors.
How similar studies have performed: While dietary interventions have been explored, this specific approach using fermented plant-based foods is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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. Exclusion Criteria: * 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. * 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
Where this trial is running
Gothenburg, ästra Götaland
- Sahlgrenska University Hospital, Wallenberg Lab — Gothenburg, ästra Götaland, Sweden (RECRUITING)
Study contacts
- Principal investigator: Rikard Landberg, PhD — Chalmers Univeristy of Technology
- Study coordinator: Elise Nordin, PhD
- Email: elise.nordin@chalmers.se
- Phone: 0046-730448420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metabolic Cardiovascular Syndrome