Status:
COMPLETED
Human Milk Oligossaccharide and Acetate Production in Vivo
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Obesity
Insulin Resistance
Eligibility:
MALE
30-65 years
Phase:
NA
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 branchi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04795804
Start Date
February 4 2020
End Date
October 15 2021
Last Update
November 3 2021
Active Locations (1)
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1
Maastricht University
Maastricht, Limburg, Netherlands, 5229ER