Fermented Plant-based Portfolio Diet 4 Metabolic Health

Last updated: March 17, 2026
Sponsor: Chalmers University of Technology
Overall Status: Completed

Phase

N/A

Condition

High Cholesterol (Hyperlipidemia)

Diabetes Prevention

Metabolic Syndrome

Treatment

Fermented plant-based foods

Habitual diet

Non-fermented plant-based foods

Clinical Study ID

NCT06587958
Chalmers-FermDiHealth
  • Ages 20-70
  • All Genders

Study 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). 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Blood donation or participation in a clinical study with blood sampling within 30days prior to screening visit and throughout the study.

  • Following any weight reduction program or having followed one during the last 6months

  • 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 themedical 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 priorto baseline.

  • Type I diabetes

  • Small bowel bacterial overgrowth

  • Diarrheal disease

  • Receiving pharmacological treatment for type II diabetes (treatments based onlifestyle interventions are acceptable, as long as it is compatible with the studyprotocol)

  • 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

Study Design

Total Participants: 89
Treatment Group(s): 3
Primary Treatment: Fermented plant-based foods
Phase:
Study Start date:
October 28, 2024
Estimated Completion Date:
December 19, 2025

Connect with a study center

  • Sahlgrenska University Hospital, Wallenberg Lab

    Gothenburg, Ästra Götaland 41346
    Sweden

    Site Not Available

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