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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04795804
Other study ID # NL71611.068.19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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