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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Cardiovascular Syndrome
• Intervention / Treatment: Dietary supplement: Fermented plant-based foods; Dietary supplement: Non-fermented plant-based foods; Other: Habitual diet

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Ästra Götaland
    • Gothenburg, Ästra Götaland, Sweden, 41346
      • Sahlgrenska University Hospital, Wallenberg Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fermented plant-based foods	Dietary supplement: Fermented plant-based foods; Participants will daily consume five different types of fermented plant-based foods, in addition to their habitual diet.
Active Comparator: Non-fermented plant-based foods	Dietary supplement: Non-fermented plant-based foods; Participants will daily consume five different types of non-fermented plant-based foods, in addition to their habitual diet.
Other: Habitual diet	Other: Habitual diet; Participants will follow their habitual diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose	Investigate if glucose differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.	6 weeks
Insulin	Investigate if insulin differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.	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.	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.	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	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.	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.	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.	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The metabolome	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.	6 weeks
Gut microbiome profiles	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.	6 weeks
Transit time	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.	5-days

Collaborators and Investigators

• Sponsor: Chalmers University of Technology
• Collaborators: Göteborg University; KU Leuven
• Investigators: Principal Investigator: Rikard Landberg, PhD, Chalmers Univeristy of Technology

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2024
• Primary Completion (Actual): December 18, 2025
• Study Completion (Actual): December 19, 2025

Study Registration Dates

• First Submitted: September 5, 2024
• First Submitted That Met QC Criteria: September 5, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Nutritional and Metabolic Diseases; Metabolic Syndrome
• Other Study ID Numbers: Chalmers-FermDiHealth

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No