Status:
RECRUITING
The Impact of Daily Intake of Short-chain Fatty Acids on Cardiometabolic Risk Factors in Individuals at Risk for Metabolic Syndrome
Lead Sponsor:
KU Leuven
Conditions:
Energy Expenditure
Metabolic Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
During this study, the effect of short-chain fatty acids on blood lipaedemia, glycemia, anthropometrics, blood pressure and energy expenditure will be investigated.
Detailed Description
The goal of this study is to investigate the impact of consuming every day a drink enriched with short-chain fatty acids for 12 weeks on the cardiometabolic health in individuals at risk of metabolic ...
Eligibility Criteria
Inclusion
- male and female participants
- central obesity ( BMI ≥ 25 kg/m² or waist circumference ≥ 80 cm for women/ ≥ 94 cm for men)
- One additional risk factor for metabolic syndrome:
- Insulin resistance (HOMA-IR ≥ 1.7 or fasting glucose ≥ 100 mg/dl)
- Triglyceride concentration ≥ 150 mg/dl
- HDL-cholesterol \< 40 mg/dl for women/ \< 50 mg/dl for men
- Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg
- knowledge of English
Exclusion
- gastrointestinal disorders such as IBD, IBS, celiac disease, chronic constipation, chronic diarrhoea
- history of abdominal surgery, except for appendectomy
- Use of antihypertensive, cholesterol lowering, glucose-regulating drugs and corticosteroids
- Use of antibiotics 3 months prior to the start or during the study
- Use of probiotics and prebiotics 2 weeks prior to the start of the study/ during the study
- Being on weight loss, gluten-free, lactose-free or vegan diet
- Pregnancy, lactation or wish to become pregnant
- Previous or current substance/ alcohol dependence or abuse
- Hyper- or hypothyroidism
- Allergy or intolerance to oat milk
Key Trial Info
Start Date :
February 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06951386
Start Date
February 11 2025
End Date
February 28 2026
Last Update
May 4 2025
Active Locations (1)
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1
KU Leuven/ UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000