Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT06587958
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT06587958
Study Brief:
Protocol Section:
NCT06587958