Fermented Plant-based Portfolio Diet 4 Metabolic Health

Not Applicable

Recruiting

• Conditions: Metabolic Cardiovascular Syndrome

• Registration Number: NCT06587958
• Lead Sponsor: Chalmers University of Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-05
• Study First Posted: 2024-09-19
• Study Start: 2024-10-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
C-reactive protein	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 Outcome Measures

Name	Time	Method
Glucose	6 weeks	Investigate if glucose differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.
Insulin	6 weeks	Investigate if insulin differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.
Liver parameters	6 weeks	Investigate if liver parameters differ between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.
Glycaemic variability	2 weeks	Investigate if glycaemic variability differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.
Mixed meal tolerance test	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
Gut microbiome	6 weeks	Investigate if the fecal microbiome differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.
Blood pressure	6 weeks	Investigate if blood pressure differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.
Blood lipid profile	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.

Trial Locations

Locations (1)

Sahlgrenska University Hospital, Wallenberg Lab; 🇸🇪 Gothenburg, ästra Götaland, Sweden