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During this study, the effect of short-chain fatty acids on blood lipaedemia, glycemia, anthropometrics, blood pressure and energy expenditure will be investigated.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drink enriched with short-chain fatty acids | Active Comparator | Treatment with enriched drink |
|
| Control drink | Placebo Comparator | Treatment with control drink |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| with short-chain fatty acids enriched drink | Dietary Supplement | Oat-based drink enriched with 15 g/L short-chain fatty acids |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting triglycerides | Triglyceride concentrations will be measured in fasting state | During study visit 1(baseline) and visit 4 (end of intervention, week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting glycemia | In fasting state glucose will be measured | During study visit 1 (baseline) and 4 (12 weeks) |
| Fasting energy expenditure | Energy expenditure will be measured for 30 minutes in fasting state using indirect calorimetry |
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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:
knowledge of English
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Riet Rosseel, Msc | Contact | +3216373428 | riet.rosseel@kuleuven.be | |
| Kristin Verbeke, Prof. | Contact | kristin.verbeke@kuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Kristin Verbeke, Prof. | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KU Leuven/ UZ Leuven | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
No IPD data will be shared with other researchers.
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| unenriched oat drink | Dietary Supplement | Oat-based drink |
|
| During study visit 1 (baseline) and 4 (12 weeks) |
| Anthropometrics: body weight | Body weight will be measured at the start of the visit | Baseline, week 4, week 8 and week 12 |
| Blood pressure | Systolic and diastolic blood pressure will be measured at the start of the visit | Baseline, week 4, week 8 and week 12 |
| Insulin resistance: HOMA-IR | HOMA-IR will be determined using fasting and postprandial (after 30 min) glucose and insulin levels. | During study visit 1 (baseline) and 4 (12 weeks) |
| HbA1c | Glycosylated hemoglobin HbA1c will be measured in fasting state | During study visit 1 (baseline) and 4 (12 weeks) |
| Short-chain fatty acids in stool | Short-chain fatty acids in stool will be measured before and after the intervention | Within 2 days prior to study visit 1 (baseline) and 4 (12 weeks) |
| Incretin hormone GLP1 | GLP-1 will be measured in fasting and postprandial state (30, 60, 90, 120, 150,180, 240, 300, 360 min) | During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours) |
| Cytokines | 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) | During study visit 1 (baseline) and 4 (12 weeks) |
| 24 hour diet recall | Subjects will complete an online 24 hour diet recall | Before the intervention and during week 4, 8 and 12 of the intervention |
| Postprandial glycemia | Glucose concentrations will be measured 30,60,90,120,150,180,240,300 and 360 min after a mixed meal tolerance test | During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours) |
| Postprandial lipaedemia: triglycerides | Triglycerides will be measured after a mixed meal tolerance test (30, 60, 90, 120, 150, 180, 240, 300, 360 min) | During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours) |
| Short-chain fatty acids in blood | 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). | During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours) |
| Appetite measurements | 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). | During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours) |
| Physical activity measurement | 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. | At the end of study visit 1 (baseline) and 4 (12 weeks) |
| Postprandial energy expenditure | Energy expenditure will be measured for 3 hours after the mixed meal tolerance test | During study visit 1 (baseline) and 4 (12 weeks) (up to 3 hours) |
| Fasting blood lipids | Total, HDL-, LDL-cholesterol (mg/dl) will be measured in fasting state | During study visit 1 (baseline) and 4 (12 weeks) |
| Metabolomics | Untargeted metabolomics analysis will be performed on fasting blood sample | During study visit 1 (baseline) and 4 (12 weeks) |
| Fasting insulinemic response | In fasting state the insulin concentration will be measured | During study visit 1 (baseline) and 4 (12 weeks) |
| Anthropometrics: waist and hip circumference | Waist- and hip circumference will be measured at the start of the visit | Baseline, week 4, week 8 and week 12 |
| Gut hormone: PYY | PYY will be measured in postprandial state at 30, 60, 90, 120, 180, 240, 300 and 360 min | During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours) |
| LBP | LBP will be measured in fasting state | During study visit 1 (baseline) and 4 (12 weeks) |
| HOMA-B | HOMA-B will be measured in fasting state | During study visit 1 (baseline) and 4 (12 weeks) |
| Insulinogenic index | 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)) | During study visit 1 (baseline) and 4 (12 weeks) |
| Postprandial insulin | Insulin concentrations will be measured 30,60,90,120,150,180,240,300 and 360 min after a mixed meal tolerance test | During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours) |
| Postprandial lipaedemia: total, LDL and HDL cholesterol | Total, HDL and LDL cholesterol will be measured after 30,60,90,120,150,180,240,300 and 360 min (mg/dl) | During study 1 (baseline) and study 4 (12 weeks) (up to 6 hours) |
| Postprandial lipaedemia: free fatty acids | Free fatty acids will be measured at 30,60,90,120,150,180,240,300 and 360 min (µmol/l) | During study 1 (baseline) and study 4 (12 weeks) (up to 6 hours) |
| % fat mass | % fat mass is measured using a bodystat bioelectrical impedance device, expressed in % | During all 4 study visits (0, 4,8 and 12 weeks) (fasted state) |
| kg fat mass | kg fat mass is measured using a bodystat bioelectrical impedance device, expressed in kg | During all 4 study visits (0, 4,8 and 12 weeks) (fasted state) |
| fat free mass (kg) | Fat free mass is measured using a bodystat bioelectrical impedance device, expressed in kg | During all 4 study visits (0, 4,8 and 12 weeks) (fasted state) |
| Dry lean weight (kg) | Dry lean weight is measured using a bodystat bioelectrical impedance device, expressed in kg | During all 4 study visits (0, 4,8 and 12 weeks) (fasted state) |
| Water percentage | % water in body is measured using a bodystat bioelectrical impedance device, expressed in % | During all 4 study visits (0, 4,8 and 12 weeks) (fasted state) |
| Total body water (L) | Volume of body water is measured using a bodystat bioelectrical impedance device, expressed in liters | During all 4 study visits (0, 4,8 and 12 weeks) (fasted state) |
| Average energy requirements | Average energy requirements is measured using a bodystat bioelectrical impedance device, expressed in kcal/day | During all 4 study visits (0, 4,8 and 12 weeks) (fasted state) |
| Basal metabolic rate | Basal metabolic rate (BMR) is measured using a bodystat bioelectrical impedance device, expressed in kcal/day | During all 4 study visits (0, 4,8 and 12 weeks) (fasted state) |
| basal metabolic rate (BMR)/ body weight | BMR/body weight is measured using a bodystat bioelectrical impedance device, expressed in kcal/kg | During all 4 study visits (0, 4,8 and 12 weeks) (fasted state) |
| BMI | BMI is measured using a bodystat bioelectrical impedance device, expressed in kg/m² | During all 4 study visits (0, 4,8 and 12 weeks) (fasted state) |
| Waist to hip ratio | Waist to hip ratio is measured using a bodystat bioelectrical impedance device | During all 4 study visits (0, 4,8 and 12 weeks) (fasted state) |
| Resistance during bioelectrical impedance | Resistance is measured using a bodystat bioelectrical impedance device, expressed in Ohm | During all 4 study visits (0, 4,8 and 12 weeks) (fasted state) |
| Free fatty acids in fasting state | Free fatty acids will be measured in fasted state (µmol/l) | During study visit 1 (baseline) and 4 (after 12 weeks) |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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