Health TrialsbyHealthPanel

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

ConditionsEnergy ExpenditureMetabolic SyndromeAnthropometryBody CompositionGlycemiaLipaemiaMetabolomicsBlood Pressure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKU Leuven

About this trial

During this study, the effect of short-chain fatty acids on blood lipaedemia, glycemia, anthropometrics, blood pressure and energy expenditure will be investigated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

male and female participants

central obesity ( BMI ≥ 25 kg/m² or waist circumference ≥ 80 cm for women/ ≥ 94 cm for men)

Insulin resistance (HOMA-IR ≥ 1.7 or fasting glucose ≥ 100 mg/dl)

Triglyceride concentration ≥ 150 mg/dl

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • with short-chain fatty acids enriched drink

    Dietary supplement

    Oat-based drink enriched with 15 g/L short-chain fatty acids

  • unenriched oat drink

    Dietary supplement

    Oat-based drink

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Drink enriched with short-chain fatty acidsActive comparator 1 intervention
Group B: Control drinkPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fasting triglycerides

Triglyceride concentrations will be measured in fasting state

Time frame
During study visit 1(baseline) and visit 4 (end of intervention, week 12)

Secondary outcomes

1

Fasting glycemia

In fasting state glucose will be measured

Time frame
During study visit 1 (baseline) and 4 (12 weeks)
2

Fasting energy expenditure

Energy expenditure will be measured for 30 minutes in fasting state using indirect calorimetry

Time frame
During study visit 1 (baseline) and 4 (12 weeks)
3

Anthropometrics: body weight

Body weight will be measured at the start of the visit

Time frame
Baseline, week 4, week 8 and week 12
4

Blood pressure

Systolic and diastolic blood pressure will be measured at the start of the visit

Time frame
Baseline, week 4, week 8 and week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

KU Leuven

Lead sponsor

Source ClinicalTrials.gov
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