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

Chalmers University of Technology

Status: Enrolling

Conditions: Metabolic Cardiovascular Syndrome

Treatments: Other: Habitual diet; Dietary Supplement: Non-fermented plant-based foods; Dietary Supplement: Fermented plant-based foods

Study type: Interventional

Funder types: Other

Identifiers

NCT06587958

Chalmers-FermDiHealth

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Fermented plant-based foods

Experimental group

Treatment:

Dietary Supplement: Fermented plant-based foods

Non-fermented plant-based foods

Active Comparator group

Treatment:

Dietary Supplement: Non-fermented plant-based foods

Habitual diet

Other group

Treatment:

Other: Habitual diet