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NCT Number: NCT06587958

Fermented Plant-based Portfolio Diet 4 Metabolic Health

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.

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Key information

Conditions

Metabolic Cardiovascular Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital, Wallenberg Lab

Gothenburg, Ästra Götaland, 41346, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fermented plant-based foods

Dietary Supplement

Participants will daily consume five different types of fermented plant-based foods, in addition to their habitual diet.

Non-fermented plant-based foods

Dietary Supplement

Participants will daily consume five different types of non-fermented plant-based foods, in addition to their habitual diet.

habitual diet

Other

Participants will follow their habitual diet.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Glucose

    Time frame: 6 weeks

    Investigate if glucose differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.

  2. Insulin

    Time frame: 6 weeks

    Investigate if insulin differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.

  3. Liver parameters

    Time frame: 6 weeks

    Investigate if liver parameters differ between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.

  4. Glycaemic variability

    Time frame: 2 weeks

    Investigate if glycaemic variability differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.

  5. Mixed meal tolerance test

    Time frame: 1-day

    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

  6. Gut microbiome

    Time frame: 6 weeks

    Investigate if the fecal microbiome differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.

  7. Blood pressure

    Time frame: 6 weeks

    Investigate if blood pressure differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.

  8. Blood lipid profile

    Time frame: 6 weeks

    Description: Investigate if c-reactive protein differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.

Other outcomes

  1. The metabolome

    Time frame: 6 weeks

    Investigate if the fecal, blood and urine metabolome differ between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.

  2. Gut microbiome profiles

    Time frame: 6 weeks

    Investigate if the response to the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet depends on the gut microbiome profile high/low Prevotella.

  3. Transit time

    Time frame: 5-days

    Investigate if transit time, measured by intake of sweet corn, differs for the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.

Sponsors and collaborators

Lead sponsor

Chalmers University of Technology

Other

Collaborators

  • Göteborg University
  • KU Leuven

Registry information

Official study title

Fermented Plant-based Portfolio Diet 4 Metabolic Health (FermDiHealth)

Acronym: FermDiHealth

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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