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Search / Trial NCT06951386

The Impact of Daily Intake of Short-chain Fatty Acids on Cardiometabolic Risk Factors in Individuals at Risk for Metabolic Syndrome

Launched by KU LEUVEN · Apr 22, 2025

Trial Information

Current as of June 04, 2025

Recruiting

Keywords

Short Chain Fatty Acids Cardiometabolic Health

ClinConnect Summary

This clinical trial is studying how daily intake of short-chain fatty acids, which are a type of healthy fat, can affect various health factors in people at risk for metabolic syndrome. Metabolic syndrome is a group of conditions that increase the risk of heart disease and diabetes, and it can include issues like high blood sugar, high cholesterol, and high blood pressure. The researchers want to see if these short-chain fatty acids can improve energy use in the body, help with fat and sugar levels in the blood, and lower blood pressure.

To participate in this study, individuals must be between 65 and 74 years old and have central obesity, meaning they have a higher than normal body weight or waist size. They should also have at least one other risk factor for metabolic syndrome, such as high blood sugar or high triglycerides (a type of fat in the blood). However, people with certain health conditions, those taking specific medications, or those following particular diets may not be eligible. Participants will be asked to take part in the study for a certain period, and they can expect to help researchers learn more about how diet can impact health, potentially leading to better treatments for those at risk for metabolic syndrome.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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:
  • 1. Insulin resistance (HOMA-IR ≥ 1.7 or fasting glucose ≥ 100 mg/dl)
  • 2. Triglyceride concentration ≥ 150 mg/dl
  • 3. HDL-cholesterol \< 40 mg/dl for women/ \< 50 mg/dl for men
  • 4. Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg
  • knowledge of English
  • Exclusion Criteria:
  • 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

About Ku Leuven

KU Leuven, a prestigious research university located in Belgium, is renowned for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, KU Leuven integrates cutting-edge research with clinical practice, facilitating the development of new therapeutic strategies and medical technologies. The institution's robust infrastructure and expertise in various fields, including biotechnology, pharmacology, and public health, position it as a leader in conducting high-quality clinical research that adheres to rigorous ethical standards and regulatory requirements. Through its clinical trials, KU Leuven aims to contribute significantly to the global biomedical landscape and enhance health outcomes for diverse populations.

Locations

Leuven, Vlaams Brabant, Belgium

Patients applied

0 patients applied

Trial Officials

Kristin Verbeke, Prof.

Principal Investigator

KU Leuven

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported