Clinical trial NCT04795804: Human Milk Oligossaccharide and Acetate Production in Vivo
Official title: The Effects of Human-like Milk Oligosaccharide and Resistant Starch on Acetate Production and Human Substrate Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 19
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Plasma acetate concentrations.
timeFrame: plasma acetate will be sampled during the CID before the consumption of a liquid high fat mixed meal
measure: Plasma acetate concentrations.
timeFrame: plasma acetate will be sampled during the CID at t=60 minutes after consumption of a liquid high fat mixed meal
measure: Plasma acetate concentrations.
timeFrame: plasma acetate will be sampled during the CID at t=120 minutes after consumption of a liquid high fat mixed meal
measure: Plasma acetate concentrations.
timeFrame: plasma acetate will be sampled during the CID at t=240 minutes after consumption of a liquid high fat mixed meal
measure: Faecal acetate concentrations.
timeFrame: Fecal acetate will be sampled in the morning before the testday
measure: Plasma butyrate concentrations.
timeFrame: plasma butyrate will be sampled during the CID before the consumption of a liquid high fat mixed meal
measure: Plasma butyrate concentrations.
timeFrame: plasma butyrate will be sampled during the CID at t=60 after consumption of a liquid high fat mixed meal
measure: Plasma butyrate concentrations.
timeFrame: plasma butyrate will be sampled during the CID at t=120 after consumption of a liquid high fat mixed meal
measure: Plasma butyrate concentrations.
timeFrame: plasma butyrate will be sampled during the CID at t=240 minutes after consumption of a liquid high fat mixed meal
measure: Fecal butyrate concentrations.
timeFrame: Fecal butyrate will be sampled in the morning before the testday
measure: Plasma propionate concentrations.
timeFrame: Plasma propionate will be sampled during the CID before the consumption of a liquid high fat mixed meal
measure: Plasma propionate concentrations.
timeFrame: Plasma propionate will be sampled during the CID t=60 minutes after the consumption of a liquid high fat mixed meal
measure: Plasma propionate concentrations.
timeFrame: Plasma propionate will be sampled during the CID t=120 minutes after the consumption of a liquid high fat mixed meal
measure: Plasma propionate concentrations.
timeFrame: Plasma propionate will be sampled during the CID t=240 minutes after the consumption of a liquid high fat mixed meal
measure: Faecal propionate concentrations.
timeFrame: Fecal propionate will be sampled in the morning before the testday
Secondary outcomes:
measure: Energy expenditure, fat and carbohydrate oxidation
timeFrame: Indirect calorimetry will be measured before and for 4 hours after the consumption of the liquid high-fat mixed meal during the whole CID
measure: Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK).
timeFrame: 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
measure: Plasma glucose concentrations
timeFrame: 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
measure: Plasma insulin concentrations
timeFrame: 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
measure: Plasma FFA concentrations
timeFrame: 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
measure: Faecal microbiota composition
timeFrame: Faecal microbiota composition will be sampled in the morning before the testday
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
References: