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

KU Leuven50 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Energy Expenditure Metabolic Syndrome

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Fasting triglycerides

Triglyceride concentrations will be measured in fasting state

Time frame: During study visit 1(baseline) and visit 4 (end of intervention, week 12)

Secondary Outcomes

Fasting glycemia

In fasting state glucose will be measured

Time frame: 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

Time frame: During study visit 1 (baseline) and 4 (12 weeks)

Anthropometrics: body weight

Body weight will be measured at the start of the visit

Time frame: Baseline, week 4, week 8 and week 12

Blood pressure

Systolic and diastolic blood pressure will be measured at the start of the visit

Time frame: 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.

Time frame: During study visit 1 (baseline) and 4 (12 weeks)

HbA1c

Glycosylated hemoglobin HbA1c will be measured in fasting state

Time frame: 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

Time frame: 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)

Time frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)

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)

Time frame: During study visit 1 (baseline) and 4 (12 weeks)

24 hour diet recall

Subjects will complete an online 24 hour diet recall

Time frame: 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

Time frame: 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)

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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

Time frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 3 hours)

Fasting blood lipids

Total, HDL-, LDL-cholesterol (mg/dl) will be measured in fasting state

Time frame: During study visit 1 (baseline) and 4 (12 weeks)

Metabolomics

Untargeted metabolomics analysis will be performed on fasting blood sample

Time frame: During study visit 1 (baseline) and 4 (12 weeks)

Fasting insulinemic response

In fasting state the insulin concentration will be measured

Time frame: 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

Time frame: 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

Time frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)

LBP

LBP will be measured in fasting state

Time frame: During study visit 1 (baseline) and 4 (12 weeks)

HOMA-B

HOMA-B will be measured in fasting state

Time frame: 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))

Time frame: 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

Time frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)

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)

Time frame: 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)

Time frame: During study 1 (baseline) and study 4 (12 weeks) (up to 6 hours)

% fat mass

% fat mass is measured using a bodystat bioelectrical impedance device, expressed in %