Actively Recruiting
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
Led by KU Leuven · Updated on 2025-05-04
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effect of daily consumption of a drink enriched with short-chain fatty acids (SCFA) on cardiometabolic health in adults at risk for metabolic syndrome. This study focuses on individuals who are overweight with disrupted cholesterol levels, high blood pressure, or elevated blood glucose. The trial aims to understand how SCFA intake influences blood lipids, glucose levels, body measurements, blood pressure, and energy use. Participants will be randomly assigned to consume either an oat-based drink enriched with 15 g/L of short-chain fatty acids or a control oat drink daily for 12 weeks. The study includes four visits: baseline (visit 1), weeks 4 and 8 (short visits for measurements), and week 12 (final visit). During these visits, metabolic and anthropometric parameters, including body weight, waist and hip circumference, body composition, blood pressure, glucose, insulin, and blood lipids, will be assessed. Throughout the study, participants will undergo detailed evaluations such as fasting and post-meal blood tests, body composition analysis, energy expenditure measurements, appetite assessments, and physical activity monitoring. Researchers will measure fasting triglycerides at the start and end, along with many other secondary outcomes like insulin resistance, blood pressure changes, and gut hormones. The total participation lasts 12 weeks, with multiple assessments to track changes over time.
CONDITIONS
Brief Title
The Impact of Daily Intake of Short-chain Fatty Acids on Cardiometabolic Risk Factors in Individuals at Risk for Metabolic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants
- Central obesity (BMI of 25 kg/m² or higher or waist circumference of at least 80 cm for women or 94 cm for men)
- At least one additional risk factor for metabolic syndrome: insulin resistance (HOMA-IR ≥ 1.7 or fasting glucose ≥ 100 mg/dl), triglycerides ≥ 150 mg/dl, HDL-cholesterol < 40 mg/dl for women or < 50 mg/dl for men, or systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg
- Knowledge of English
You will not qualify if you...
- Gastrointestinal disorders such as inflammatory bowel disease, irritable bowel syndrome, celiac disease, chronic constipation, or chronic diarrhea
- History of abdominal surgery except appendectomy
- Use of antihypertensive, cholesterol-lowering, glucose-regulating drugs, or corticosteroids
- Use of antibiotics within 3 months before or during the study
- Use of probiotics or prebiotics within 2 weeks before or during the study
- Following a weight loss, gluten-free, lactose-free, or vegan diet
- Pregnancy, lactation, or desire to become pregnant
- Previous or current substance or alcohol dependence or abuse
- Hyperthyroidism or hypothyroidism
- Allergy or intolerance to oat milk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants consume a daily oat-based drink enriched with short-chain fatty acids or a control oat drink for 12 weeks. During this time, various health parameters including blood pressure, body composition, and metabolic markers are measured.
4 visits (in-person) at baseline, week 4, week 8, and week 12
Trial Site Locations
Total: 1 location
1
KU Leuven/ UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
R
Riet Rosseel, Msc
K
Kristin Verbeke, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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