Human Milk Oligossaccharide and Acetate Production in Vivo

Obesity Clinical Trial

Official title:

The Effects of Human-like Milk Oligosaccharide and Resistant Starch on Acetate Production and Human Substrate Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04795804
• Other study ID #: NL71611.068.19
• Status: Completed
• Phase: N/A
• Start date: February 4, 2020
• Est. completion date: October 15, 2021

Study information

• Verified date: March 2021
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Dietary Supplement:
• Human Milk Oligossaccharide
The day before the CIDs, the participants receive the supplements 3x a day in randomized order
• Maltodextrin
The day before the CIDs, the participants receive the supplements 3x a day in randomized order
• Human Milk Oligossaccharide and resistant starch
The day before the CIDs, the participants receive the supplements 3x a day in randomized order

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma acetate concentrations.	During the clinical investigation day plasma acetate will be sampled	plasma acetate will be sampled during the CID before the consumption of a liquid high fat mixed meal
Primary	Plasma acetate concentrations.	During the clinical investigation day plasma acetate will be sampled	plasma acetate will be sampled during the CID at t=60 minutes after consumption of a liquid high fat mixed meal
Primary	Plasma acetate concentrations.	During the clinical investigation day plasma acetate will be sampled	plasma acetate will be sampled during the CID at t=120 minutes after consumption of a liquid high fat mixed meal
Primary	Plasma acetate concentrations.	During the clinical investigation day plasma acetate will be sampled	plasma acetate will be sampled during the CID at t=240 minutes after consumption of a liquid high fat mixed meal
Primary	Faecal acetate concentrations.	On the day of clinical investigation day, fecal acetate will be sampled	Fecal acetate will be sampled in the morning before the testday
Primary	Plasma butyrate concentrations.	During the clinical investigation day, plasma butyrate will be sampled	plasma butyrate will be sampled during the CID before the consumption of a liquid high fat mixed meal
Primary	Plasma butyrate concentrations.	During the clinical investigation day, plasma butyrate will be sampled	plasma butyrate will be sampled during the CID at t=60 after consumption of a liquid high fat mixed meal
Primary	Plasma butyrate concentrations.	During the clinical investigation day, plasma butyrate will be sampled	plasma butyrate will be sampled during the CID at t=120 after consumption of a liquid high fat mixed meal
Primary	Plasma butyrate concentrations.	During the clinical investigation day, plasma butyrate will be sampled	plasma butyrate will be sampled during the CID at t=240 minutes after consumption of a liquid high fat mixed meal
Primary	Fecal butyrate concentrations.	On the day of clinical investigation day, fecal butyrate will be sampled	Fecal butyrate will be sampled in the morning before the testday
Primary	Plasma propionate concentrations.	During the clinical investigation day, plasma propionate will be sampled	Plasma propionate will be sampled during the CID before the consumption of a liquid high fat mixed meal
Primary	Plasma propionate concentrations.	During the clinical investigation day, plasma propionate will be sampled	Plasma propionate will be sampled during the CID t=60 minutes after the consumption of a liquid high fat mixed meal
Primary	Plasma propionate concentrations.	During the clinical investigation day, plasma propionate will be sampled	Plasma propionate will be sampled during the CID t=120 minutes after the consumption of a liquid high fat mixed meal
Primary	Plasma propionate concentrations.	During the clinical investigation day, plasma propionate will be sampled	Plasma propionate will be sampled during the CID t=240 minutes after the consumption of a liquid high fat mixed meal
Primary	Faecal propionate concentrations.	On the day of clinical investigation day, fecal propionate will be sampled	Fecal propionate will be sampled in the morning before the testday
Secondary	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);	Indirect calorimetry will be measured before and for 4 hours after the consumption of the liquid high-fat mixed meal during the whole CID
Secondary	Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK).	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
Secondary	Plasma glucose concentrations	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
Secondary	Plasma insulin 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
Secondary	Plasma FFA 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
Secondary	Faecal microbiota composition	Faecal microbiota composition will be assessed via16S rRNA gene sequencing	Faecal microbiota composition will be sampled in the morning before the testday