The Impact of Daily Intake of Short-chain Fatty Acids on Cardiometabolic Risk Factors in Individuals at Risk for Metabolic Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: with short-chain fatty acids enriched drink, unenriched oat drink.
- Who it may be relevant to
- Registry conditions: Energy Expenditure, Metabolic Syndrome, Anthropometry, Body Composition. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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).
Interventions
- Dietary supplement with short-chain fatty acids enriched drink
Oat-based drink enriched with 15 g/L short-chain fatty acids - Dietary supplement unenriched oat drink
Oat-based drink
Primary outcome measures
- Fasting triglycerides [Time frame: During study visit 1(baseline) and visit 4 (end of intervention, week 12)]
Secondary outcome measures (12)
- Fasting glycemia [Time frame: During study visit 1 (baseline) and 4 (12 weeks)]
- Fasting energy expenditure [Time frame: During study visit 1 (baseline) and 4 (12 weeks)]
- Anthropometrics: body weight [Time frame: Baseline, week 4, week 8 and week 12]
- Blood pressure [Time frame: Baseline, week 4, week 8 and week 12]
- Insulin resistance: HOMA-IR [Time frame: During study visit 1 (baseline) and 4 (12 weeks)]
- HbA1c [Time frame: During study visit 1 (baseline) and 4 (12 weeks)]
- Short-chain fatty acids in stool [Time frame: Within 2 days prior to study visit 1 (baseline) and 4 (12 weeks)]
- Incretin hormone GLP1 [Time frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)]
- Cytokines [Time frame: During study visit 1 (baseline) and 4 (12 weeks)]
- 24 hour diet recall [Time frame: Before the intervention and during week 4, 8 and 12 of the intervention]
- Postprandial glycemia [Time frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)]
- Postprandial lipaedemia: triglycerides [Time frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)]
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:
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
Belgium · 1 center
- KU Leuven/ UZ Leuven — Leuven
Identifiers
NCT: NCT06951386 · S69712