Phase
Condition
High Cholesterol (Hyperlipidemia)
Diabetes Prevention
Metabolic Syndrome
Treatment
Fermented plant-based foods
Habitual diet
Non-fermented plant-based foods
Clinical Study ID
Ages 20-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Exclusion Criteria:
Blood donation or participation in a clinical study with blood sampling within 30days prior to screening visit and throughout the study.
Following any weight reduction program or having followed one during the last 6months
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 themedical 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 priorto baseline.
Type I diabetes
Small bowel bacterial overgrowth
Diarrheal disease
Receiving pharmacological treatment for type II diabetes (treatments based onlifestyle interventions are acceptable, as long as it is compatible with the studyprotocol)
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
Connect with a study center
Sahlgrenska University Hospital, Wallenberg Lab
Gothenburg, Ästra Götaland 41346
SwedenSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.