An interventional study of Human Milk Oligossaccharide and Maltodextrin in Obesity and Insulin Resistance, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to male participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-03.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Basic science
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.
1,960 studies on the registry are indexed under Insulin Resistance; 305 are open to participants now.
This study's enrollment of 19 is below the median of 40 across 1,535 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
11.43 g (3 x 3.81 g) maltodextrin the day before the clinical investigation day
Dietary Supplement: Maltodextrin
12 g (3 x 4 g) of the human milk-like oligosaccharide the day before the clinical investigation day
Dietary Supplement: Human Milk Oligossaccharide
12 g (3 x 4 g) of the human milk-like oligosaccharide and 7.5g resistant starch (3 x 2.5 g) the day before the clinical investigation day
Dietary Supplement: Human Milk Oligossaccharide and resistant starch
The day before the CIDs, the participants receive the supplements 3x a day in randomized order
The day before the CIDs, the participants receive the supplements 3x a day in randomized order
The day before the CIDs, the participants receive the supplements 3x a day in randomized order
Plasma acetate concentrations.
During the clinical investigation day plasma acetate will be sampled
Time frame: plasma acetate will be sampled during the CID before the consumption of a liquid high fat mixed meal
Plasma acetate concentrations.
During the clinical investigation day plasma acetate will be sampled
Time frame: plasma acetate will be sampled during the CID at t=60 minutes after consumption of a liquid high fat mixed meal
Plasma acetate concentrations.
During the clinical investigation day plasma acetate will be sampled
Time frame: plasma acetate will be sampled during the CID at t=120 minutes after consumption of a liquid high fat mixed meal
Plasma acetate concentrations.
During the clinical investigation day plasma acetate will be sampled
Time frame: plasma acetate will be sampled during the CID at t=240 minutes after consumption of a liquid high fat mixed meal
Faecal acetate concentrations.
On the day of clinical investigation day, fecal acetate will be sampled
Time frame: Fecal acetate will be sampled in the morning before the testday
Plasma butyrate concentrations.
During the clinical investigation day, plasma butyrate will be sampled
Time frame: plasma butyrate will be sampled during the CID before the consumption of a liquid high fat mixed meal
Plasma butyrate concentrations.
During the clinical investigation day, plasma butyrate will be sampled
Time frame: plasma butyrate will be sampled during the CID at t=60 after consumption of a liquid high fat mixed meal
Plasma butyrate concentrations.
During the clinical investigation day, plasma butyrate will be sampled
Time frame: plasma butyrate will be sampled during the CID at t=120 after consumption of a liquid high fat mixed meal
Plasma butyrate concentrations.
During the clinical investigation day, plasma butyrate will be sampled
Time frame: plasma butyrate will be sampled during the CID at t=240 minutes after consumption of a liquid high fat mixed meal
Fecal butyrate concentrations.
On the day of clinical investigation day, fecal butyrate will be sampled
Time frame: Fecal butyrate will be sampled in the morning before the testday
Plasma propionate concentrations.
During the clinical investigation day, plasma propionate will be sampled
Time frame: Plasma propionate will be sampled during the CID before the consumption of a liquid high fat mixed meal
Plasma propionate concentrations.
During the clinical investigation day, plasma propionate will be sampled
Time frame: Plasma propionate will be sampled during the CID t=60 minutes after the consumption of a liquid high fat mixed meal
Plasma propionate concentrations.
During the clinical investigation day, plasma propionate will be sampled
Time frame: Plasma propionate will be sampled during the CID t=120 minutes after the consumption of a liquid high fat mixed meal
Plasma propionate concentrations.
During the clinical investigation day, plasma propionate will be sampled
Time frame: Plasma propionate will be sampled during the CID t=240 minutes after the consumption of a liquid high fat mixed meal
Faecal propionate concentrations.
On the day of clinical investigation day, fecal propionate will be sampled
Time frame: Fecal propionate will be sampled in the morning before the testday
Energy expenditure, fat and carbohydrate oxidation
Energy expenditure, fat and carbohydrate oxidation will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands);
Time frame: Indirect calorimetry will be measured before and for 4 hours after the consumption of the liquid high-fat mixed meal during the whole CID
Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK).
Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK).
Time frame: 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
Plasma glucose concentrations
Plasma glucose concentrations
Time frame: 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 insulin concentrations
Plasma insulin concentrations
Time frame: 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 FFA concentrations
Plasma FFA concentrations
Time frame: 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
Faecal microbiota composition
Faecal microbiota composition will be assessed via16S rRNA gene sequencing
Time frame: Faecal microbiota composition will be sampled in the morning before the testday
Plan to share: Undecided
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Maastricht University Medical Center