Clinical trial NCT06951386: The Impact of Daily Intake of Short-chain Fatty Acids on Cardiometabolic Risk Factors in Individuals at Risk for Metabolic Syndrome
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Energy Expenditure
Metabolic Syndrome
Anthropometry
Body Composition
Glycemia
Lipaemia
Metabolomics
Blood Pressure
Keywords: short-chain fatty acids
cardiometabolic health
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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).

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

Primary outcomes:
measure: Fasting triglycerides
timeFrame: During study visit 1(baseline) and visit 4 (end of intervention, week 12)
Secondary outcomes:
measure: Fasting glycemia
timeFrame: During study visit 1 (baseline) and 4 (12 weeks)
measure: Fasting energy expenditure
timeFrame: During study visit 1 (baseline) and 4 (12 weeks)
measure: Anthropometrics: body weight
timeFrame: Baseline, week 4, week 8 and week 12
measure: Blood pressure
timeFrame: Baseline, week 4, week 8 and week 12
measure: Insulin resistance: HOMA-IR
timeFrame: During study visit 1 (baseline) and 4 (12 weeks)
measure: HbA1c
timeFrame: During study visit 1 (baseline) and 4 (12 weeks)
measure: Short-chain fatty acids in stool
timeFrame: Within 2 days prior to study visit 1 (baseline) and 4 (12 weeks)
measure: Incretin hormone GLP1
timeFrame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
measure: Cytokines
timeFrame: During study visit 1 (baseline) and 4 (12 weeks)
measure: 24 hour diet recall
timeFrame: Before the intervention and during week 4, 8 and 12 of the intervention
measure: Postprandial glycemia
timeFrame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
measure: Postprandial lipaedemia: triglycerides
timeFrame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
measure: Short-chain fatty acids in blood
timeFrame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
measure: Appetite measurements
timeFrame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
measure: Physical activity measurement
timeFrame: At the end of study visit 1 (baseline) and 4 (12 weeks)
measure: Postprandial energy expenditure
timeFrame: During study visit 1 (baseline) and 4 (12 weeks) (up to 3 hours)
measure: Fasting blood lipids
timeFrame: During study visit 1 (baseline) and 4 (12 weeks)
measure: Metabolomics
timeFrame: During study visit 1 (baseline) and 4 (12 weeks)
measure: Fasting insulinemic response
timeFrame: During study visit 1 (baseline) and 4 (12 weeks)
measure: Anthropometrics: waist and hip circumference
timeFrame: Baseline, week 4, week 8 and week 12
measure: Gut hormone: PYY
timeFrame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
measure: LBP
timeFrame: During study visit 1 (baseline) and 4 (12 weeks)
measure: HOMA-B
timeFrame: During study visit 1 (baseline) and 4 (12 weeks)
measure: Insulinogenic index
timeFrame: During study visit 1 (baseline) and 4 (12 weeks)
measure: Postprandial insulin
timeFrame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
measure: Postprandial lipaedemia: total, LDL and HDL cholesterol
timeFrame: During study 1 (baseline) and study 4 (12 weeks) (up to 6 hours)
measure: Postprandial lipaedemia: free fatty acids
timeFrame: During study 1 (baseline) and study 4 (12 weeks) (up to 6 hours)
measure: % fat mass
timeFrame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
measure: kg fat mass
timeFrame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
measure: fat free mass (kg)
timeFrame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
measure: Dry lean weight (kg)
timeFrame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
measure: Water percentage
timeFrame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
measure: Total body water (L)
timeFrame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
measure: Average energy requirements
timeFrame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
measure: Basal metabolic rate
timeFrame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
measure: basal metabolic rate (BMR)/ body weight
timeFrame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
measure: BMI
timeFrame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
measure: Waist to hip ratio
timeFrame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
measure: Resistance during bioelectrical impedance
timeFrame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
measure: Free fatty acids in fasting state
timeFrame: During study visit 1 (baseline) and 4 (after 12 weeks)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven/ UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Kristin Verbeke, Prof.
role: PRINCIPAL_INVESTIGATOR
References: