The Impact of Daily Intake of Short-chain Fatty Acids on Cardiometabolic Risk Factors in Individuals at Risk for Metabolic Syndrome (12OATS)

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

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

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome; Body Composition; Blood Pressure; Anthropometry; Energy Expenditure; Metabolomics; Glycemia; Lipaemia
• Intervention / Treatment: Dietary supplement: with short-chain fatty acids enriched drink; Dietary supplement: unenriched oat drink

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 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).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristin Verbeke, Prof.; Email: kristin.verbeke@kuleuven.be
• Study Contact Backup: Name: Riet Rosseel, Msc; Phone Number: +3216373428; Email: riet.rosseel@kuleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • KU Leuven/ UZ Leuven
      • Contact: Kristin Verbeke, Prof.; Email: kristin.verbeke@kuleuven.be
      • Principal Investigator: Kristin Verbeke, Prof.
      • Contact: Riet Rosseel, Msc; Phone Number: +3216373428; Email: riet.rosseel@kuleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Drink enriched with short-chain fatty acids; Treatment with enriched drink	Dietary supplement: with short-chain fatty acids enriched drink; Oat-based drink enriched with 15 g/L short-chain fatty acids
Placebo Comparator: Control drink; Treatment with control drink	Dietary supplement: unenriched oat drink; Oat-based drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)
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)
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)
% 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)
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)
Fasting blood lipids	Total, HDL-, LDL-cholesterol (mg/dl) will be measured in fasting state	During study visit 1 (baseline) and 4 (12 weeks)
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)
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)

Collaborators and Investigators

• Sponsor: KU Leuven
• Investigators: Principal Investigator: Kristin Verbeke, Prof., KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: short-chain fatty acids; cardiometabolic health
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: S69712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD data will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No