Status:
COMPLETED
Butyrate/Hexanoate in Metabolic Health
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Metabolic Disease
Eligibility:
MALE
40-70 years
Phase:
NA
Brief Summary
In this study, we aim to identify a well consumable butyrate/hexanoate-enriched oil that increases circulating SCFA concentrations and improves postprandial substrate metabolism, which could be furthe...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Overweight/obese men (BMI ≥ 25 kg/m2 and ≤ 34.9 kg/m2);
- Aged 40 - 70 years;
- Caucasian;
- Normal blood pressure (systolic blood pressure 100-140mmHg, diastolic blood pressure 60-90 mmHg);
- Weight stable for at least 3 months (± 2 kg).
- Exclusion criteria
- Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.1 mmol/L)
- Gastroenterological diseases or abdominal surgery (gallbladder removal and appendix removal are allowed)
- Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
- Lactose intolerance or other disorders that affect digestion (such as celiac disease)
- Abuse of products; alcohol and drugs, excessive nicotine use defined as \>20 cigarettes per day; and excessive alcohol use defined as (\> 15 units/week)
- Plans to lose weight or following of a hypocaloric diet in the following three months;
- Regular supplementation of pre- or probiotic products (for example Yakult, Activia), 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. betablockers, corticosteroids, statins or NSAIDs);
- Regular use of laxation products in 3 months prior start of study or during study period;
- Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
- Follow a vegan diet or vegetarian diet.
Exclusion
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04662411
Start Date
January 13 2021
End Date
July 26 2021
Last Update
November 29 2021
Active Locations (1)
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1
Maastricht University Medical Centre
Maastricht, Netherlands