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

Catholic University (KU) of Leuven

Status: Enrolling

Conditions: Metabolomics; Anthropometry; Lipaemia; Energy Expenditure; Blood Pressure; Body Composition; Metabolic Syndrome; Glycemia

Treatments: Dietary Supplement: unenriched oat drink; Dietary Supplement: with short-chain fatty acids enriched drink

Study type: Interventional

Funder types: Other

Identifiers

NCT06951386

S69712

Details and patient eligibility

About

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

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Drink enriched with short-chain fatty acids

Active Comparator group

Description:

Treatment with enriched drink

Treatment:

Dietary Supplement: with short-chain fatty acids enriched drink

Control drink

Placebo Comparator group

Description:

Treatment with control drink

Treatment:

Dietary Supplement: unenriched oat drink