Insulin Resistance, Obesity
Conditions
Brief summary
The study investigators hypothesize (1) that the SCFA/acetate metabolism differs between metabolic phenotypes and (2) that using a mixture of fibres that differ in degree of polymerization and branching namely a resistant starch and a human-like milk oligosaccharide enhance the acetate availability in the distal colon and systemic circulation, consequently leading to its metabolic effects. To study this, the investigators will supplement lean, normoglycaemic vs. overweight/obese, prediabetic men with the fibre mixture the day before the clinical investigation day (CID) and study during the CID its effects on fasting and postprandial substrate and energy metabolism.
Interventions
DIETARY_SUPPLEMENTHuman Milk Oligossaccharide
The day before the CIDs, the participants receive the supplements 3x a day in randomized order
DIETARY_SUPPLEMENTMaltodextrin
The day before the CIDs, the participants receive the supplements 3x a day in randomized order
DIETARY_SUPPLEMENTHuman Milk Oligossaccharide and resistant starch
The day before the CIDs, the participants receive the supplements 3x a day in randomized order
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Lean (BMI ≥ 20kg/m2 and ≤ 24.9kg/m2) healthy men aged 30 - 65 years as well as overweight/obese (BMI ≥ 25kg/m2 and ≤ 34.9kg/m2) prediabetic men aged between 30 - 65 years
Exclusion criteria
* Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.1 mmol/L and 2h glucose ≥ 11.1 mmol/L) * Gastroenterological diseases or abdominal surgery; * Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years; * Abuse of products; alcohol and drugs, excessive nicotine use defined as \>20 cigarettes per day; * Plans to lose weight or following of a hypocaloric diet; * Regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study; * Intensive exercise training more than three hours a week; * Use of any medication that influences glucose or fat metabolism and inflammation (i.e. NSAIDs); * Regular use of laxation products; * Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition). * Follow a vegan diet.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Faecal propionate concentrations. | Fecal propionate will be sampled in the morning before the testday | On the day of clinical investigation day, fecal propionate will be sampled |
| Plasma acetate concentrations. | plasma acetate will be sampled during the CID before the consumption of a liquid high fat mixed meal | During the clinical investigation day plasma acetate will be sampled |
| Faecal acetate concentrations. | Fecal acetate will be sampled in the morning before the testday | On the day of clinical investigation day, fecal acetate will be sampled |
| Plasma butyrate concentrations. | plasma butyrate will be sampled during the CID before the consumption of a liquid high fat mixed meal | During the clinical investigation day, plasma butyrate will be sampled |
| Fecal butyrate concentrations. | Fecal butyrate will be sampled in the morning before the testday | On the day of clinical investigation day, fecal butyrate will be sampled |
| Plasma propionate concentrations. | Plasma propionate will be sampled during the CID before the consumption of a liquid high fat mixed meal | During the clinical investigation day, plasma propionate will be sampled |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Energy expenditure, fat and carbohydrate oxidation | Indirect calorimetry will be measured before and for 4 hours after the consumption of the liquid high-fat mixed meal during the whole CID | Energy expenditure, fat and carbohydrate oxidation will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands); |
| Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK). | Breath H2 will be sampled during the CID before and at t=30, t=60, t=90, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal | Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK). |
| Plasma glucose concentrations | Plasma glucose concentrations will be sampled during the CID before and t=0, t=30, t=60, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal | Plasma glucose concentrations |
| Plasma insulin concentrations | Plasma insulin concentrations will be sampled during the CID before and at t=0, t=30, t=60, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal | Plasma insulin concentrations |
| Plasma FFA concentrations | Plasma FFA concentrations will be sampled during the CID before and at t=0, t=30, t=60, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal | Plasma FFA concentrations |
| Faecal microbiota composition | Faecal microbiota composition will be sampled in the morning before the testday | Faecal microbiota composition will be assessed via16S rRNA gene sequencing |
Countries
Netherlands
Outcome results
None listed