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NCT Number: NCT06951386

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

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

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Key information

Conditions

Energy Expenditure Anthropometry Blood Pressure Body Composition Dyslipidemias Glucose Metabolism Disorders Glycemia Hyperinsulinism Hyperlipidemias Insulin Resistance Lipaemia Lipid Metabolism Disorders Metabolic Diseases Metabolic Syndrome Metabolomics Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven/ UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location status: Recruiting

Location contact

Kristin Verbeke, Prof.

CONTACT

[email protected]

Kristin Verbeke, Prof.

PRINCIPAL_INVESTIGATOR

Riet Rosseel, Msc

CONTACT

[email protected]

+3216373428

About this study

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 syndrome. This means the investigators are looking for people with overweight and disrupted cholesterol, high blood pressure or elevated blood glucose. The individuals will consume for 12 weeks a drink either enriched with SCFA or a control drink (randomly allocated). Before and after this period (study visit 1 and 4), a study visit will take place in which metabolic parameters will be measured such as blood pressure, body weight, waist- and hip circumference, body composition, energy expenditure, glucose, insulin and blood lipids. After 4 and 8 weeks, anthropometrics, blood pressure and body composition will be measured during a short study visit (study visit 2 and 3).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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 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

Treatment and study plan

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

Primary outcomes

  1. Fasting triglycerides

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

    Triglyceride concentrations will be measured in fasting state

Secondary outcomes

  1. Fasting glycemia

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

    In fasting state glucose will be measured

  2. Fasting energy expenditure

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

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

  3. Anthropometrics: body weight

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

    Body weight will be measured at the start of the visit

  4. Blood pressure

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

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

  5. Insulin resistance: HOMA-IR

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

    HOMA-IR will be determined using fasting and postprandial (after 30 min) glucose and insulin levels.

  6. HbA1c

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

    Glycosylated hemoglobin HbA1c will be measured in fasting state

  7. Short-chain fatty acids in stool

    Time frame: Within 2 days prior to study visit 1 (baseline) and 4 (12 weeks)

    Short-chain fatty acids in stool will be measured before and after the intervention

  8. Incretin hormone GLP1

    Time frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)

    GLP-1 will be measured in fasting and postprandial state (30, 60, 90, 120, 150,180, 240, 300, 360 min)

  9. Cytokines

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

    Cytokines such as IL-1β, IL-6, IL-10, TNF-alpha, IL-13 and interferon (IFN)-γ will be measured in fasting state (unit: pg/ml)

  10. 24 hour diet recall

    Time frame: Before the intervention and during week 4, 8 and 12 of the intervention

    Subjects will complete an online 24 hour diet recall

  11. Postprandial glycemia

    Time frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)

    Glucose concentrations will be measured 30,60,90,120,150,180,240,300 and 360 min after a mixed meal tolerance test

  12. Postprandial lipaedemia: triglycerides

    Time frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)

    Triglycerides will be measured after a mixed meal tolerance test (30, 60, 90, 120, 150, 180, 240, 300, 360 min)

  13. Short-chain fatty acids in blood

    Time frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)

    Short-chain fatty acids (acetate, propionate and butyrate) concentrations will be measured in fasting and postprandial state (30, 60, 90, 120, 180, 240, 300, 360 min).

  14. Appetite measurements

    Time frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)

    Appetite in response to mixed meal tolerance test, will be measured using 100 millimeter (mm) Visual Analogue Scale (indicating score on line of 100 mm, 0 mm: don't agree, 100 mm: totally agree) in fasting (i.e. 0 minute) and postprandial state (30, 60, 90, 120,150, 180, 240, 300 and 360 min).

  15. Physical activity measurement

    Time frame: At the end of study visit 1 (baseline) and 4 (12 weeks)

    Individuals complete the short form of the international physical activity questionnaire (IPAQ) before and after the intervention. In the IPAQ participants fill in the number of days/ week they spent doing vigorous, moderate activity and walking and how long (hours and minutes) per day they do this. It also includes a question about how long they sit on a day.

  16. Postprandial energy expenditure

    Time frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 3 hours)

    Energy expenditure will be measured for 3 hours after the mixed meal tolerance test

  17. Fasting blood lipids

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

    Total, HDL-, LDL-cholesterol (mg/dl) will be measured in fasting state

  18. Metabolomics

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

    Untargeted metabolomics analysis will be performed on fasting blood sample

  19. Fasting insulinemic response

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

    In fasting state the insulin concentration will be measured

  20. Anthropometrics: waist and hip circumference

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

    Waist- and hip circumference will be measured at the start of the visit

  21. Gut hormone: PYY

    Time frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)

    PYY will be measured in postprandial state at 30, 60, 90, 120, 180, 240, 300 and 360 min

  22. LBP

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

    LBP will be measured in fasting state

  23. HOMA-B

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

    HOMA-B will be measured in fasting state

  24. Insulinogenic index

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

    IGI will be measured in fasting state. IGI is ratio of (postprandial insulin (30 min) -fasting insulin (mU/L)) over (postprandial glucose (30 min) - fasting glucose (mmol/L))

  25. Postprandial insulin

    Time frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)

    Insulin concentrations will be measured 30,60,90,120,150,180,240,300 and 360 min after a mixed meal tolerance test

  26. Postprandial lipaedemia: total, LDL and HDL cholesterol

    Time frame: During study 1 (baseline) and study 4 (12 weeks) (up to 6 hours)

    Total, HDL and LDL cholesterol will be measured after 30,60,90,120,150,180,240,300 and 360 min (mg/dl)

  27. Postprandial lipaedemia: free fatty acids

    Time frame: During study 1 (baseline) and study 4 (12 weeks) (up to 6 hours)

    Free fatty acids will be measured at 30,60,90,120,150,180,240,300 and 360 min (µmol/l)

  28. % fat mass

    Time frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)

    % fat mass is measured using a bodystat bioelectrical impedance device, expressed in %

  29. kg fat mass

    Time frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)

    kg fat mass is measured using a bodystat bioelectrical impedance device, expressed in kg

  30. fat free mass (kg)

    Time frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)

    Fat free mass is measured using a bodystat bioelectrical impedance device, expressed in kg

  31. Dry lean weight (kg)

    Time frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)

    Dry lean weight is measured using a bodystat bioelectrical impedance device, expressed in kg

  32. Water percentage

    Time frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)

    % water in body is measured using a bodystat bioelectrical impedance device, expressed in %

  33. Total body water (L)

    Time frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)

    Volume of body water is measured using a bodystat bioelectrical impedance device, expressed in liters

  34. Average energy requirements

    Time frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)

    Average energy requirements is measured using a bodystat bioelectrical impedance device, expressed in kcal/day

  35. Basal metabolic rate

    Time frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)

    Basal metabolic rate (BMR) is measured using a bodystat bioelectrical impedance device, expressed in kcal/day

  36. basal metabolic rate (BMR)/ body weight

    Time frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)

    BMR/body weight is measured using a bodystat bioelectrical impedance device, expressed in kcal/kg

  37. BMI

    Time frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)

    BMI is measured using a bodystat bioelectrical impedance device, expressed in kg/m²

  38. Waist to hip ratio

    Time frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)

    Waist to hip ratio is measured using a bodystat bioelectrical impedance device

  39. Resistance during bioelectrical impedance

    Time frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)

    Resistance is measured using a bodystat bioelectrical impedance device, expressed in Ohm

  40. Free fatty acids in fasting state

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

    Free fatty acids will be measured in fasted state (µmol/l)

Study contacts

Contact information is provided by the study sponsor or research team.

Kristin Verbeke, Prof.

CONTACT

[email protected]

Riet Rosseel, Msc

CONTACT

[email protected]

+3216373428

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

The Impact of 12 Weeks Intervention With Plant-based Oat Drink Rich in Short-chain Fatty Acids on Postprandial Lipidemia in Individuals at Risk for Metabolic Syndrome

Acronym: 12OATS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 30, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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