Human Milk Oligossaccharide and Acetate Production in Vivo

Not Applicable

Completed

• Conditions: Insulin Resistance; Obesity
• Interventions: Dietary Supplement: Human Milk Oligossaccharide; Dietary Supplement: Human Milk Oligossaccharide and resistant starch; Dietary Supplement: Maltodextrin

• Registration Number: NCT04795804
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-04
• Study First Submitted: 2020-12-04
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-12
• Primary Completion: 2021-10-15
• Study Completion: 2021-10-15
• Last Update Submitted: 2021-11-02
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Human milk-like oligosaccharide alone	Human Milk Oligossaccharide	12 g (3 x 4 g) of the human milk-like oligosaccharide the day before the clinical investigation day
Human milk-like oligosaccharide and resistant starch	Human Milk Oligossaccharide and resistant starch	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
Placebo	Maltodextrin	11.43 g (3 x 3.81 g) maltodextrin the day before the clinical investigation day

Primary Outcome Measures

Name	Time	Method
Plasma acetate concentrations.	plasma acetate will be sampled during the CID at t=240 minutes after 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 at t=240 minutes after 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 t=240 minutes after the consumption of a liquid high fat mixed meal	During the clinical investigation day, plasma propionate will be sampled
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

Secondary Outcome Measures

Name	Time	Method
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);
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
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
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

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Limburg, Netherlands