Status:
RECRUITING
Fermented Plant-based Portfolio Diet 4 Metabolic Health
Lead Sponsor:
Chalmers University of Technology
Collaborating Sponsors:
KU Leuven
Göteborg University
Conditions:
Metabolic Cardiovascular Syndrome
Eligibility:
All Genders
20-70 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06587958
Start Date
October 28 2024
End Date
December 31 2025
Last Update
May 4 2025
Active Locations (1)
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1
Sahlgrenska University Hospital, Wallenberg Lab
Gothenburg, Ästra Götaland, Sweden, 41346