Fermented Plant-based Portfolio Diet 4 Metabolic Health

NCT06587958 | Completed

• 1 other identifier: Chalmers-FermDiHealth
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Cardiovascular Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Glucose

  6 weeks

• Insulin

  6 weeks

• Liver parameters

  6 weeks

• Glycaemic variability

  2 weeks

• Mixed meal tolerance test

  1-day

Other Outcomes (3)

• The metabolome

  6 weeks

• Gut microbiome profiles

  6 weeks

• Transit time

  5-days

Study Arms (3)

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

Interventions

Fermented plant-based foods DIETARY_SUPPLEMENT

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

Fermented plant-based foods

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.

Non-fermented plant-based foods

Habitual diet OTHER

Participants will follow their habitual diet.

Habitual diet

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Chalmers University of Technology: lead
• KU Leuven: collaborator
• Göteborg University: collaborator

Study Sites (1)

Sahlgrenska University Hospital, Wallenberg Lab

Gothenburg, Ästra Götaland, 41346, Sweden

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Rikard Landberg, PhD

  Chalmers Univeristy of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: October 28, 2024
• Primary Completion: December 18, 2025
• Study Completion: December 19, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

SE (1)