Metabolic Disease
Conditions
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 further used for a long-term study.
Interventions
DIETARY_SUPPLEMENTPlacebo
acute intake of 0 mg butyrate and hexanoate
DIETARY_SUPPLEMENTbutyrate and hexanoate amount 1
acute intake of 650 mg butyrate and hexanoate
DIETARY_SUPPLEMENTbutyrate and hexanoate amount 2
acute intake of 1325 mg butyrate and hexanoate
DIETARY_SUPPLEMENTbutyrate and hexanoate amount 3
acute intake of 2000 mg butyrate and hexanoate
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
40 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma butyrate concentrations | Fasting and postprandial butyrate will be measured before and up to 6 hours after intake of the supplement | Plasma butyrate concentrations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Circulating Free Fatty Acids | Fasting and postprandial Free Fatty Acids will be measured before and up to 6 hours after intake of the supplement | Circulating Free Fatty Acids assessed in plasma |
| Circulating Glycerol | Fasting and postprandial Glycerol will be measured before and up to 6 hours after intake of the supplement | Circulating Glycerol assessed in plasma |
| Circulating Glucose | Fasting and postprandial glucose will be measured before and up to 6 hours after intake of the supplement | Circulating Glucose assessed in plasma |
| Circulating insulin | Fasting and postprandial insulin will be measured before and up to 6 hours after intake of the supplement | Circulating . insulin will be assessed in plasma |
| Breath H2 | Fasting and postprandial breath H2 will be measured before and up to 6 hours after intake of the supplement | Breath H2 using Gastrolyzer |
| Circulating Triglycerides (TG) | Fasting and postprandial TG will be measured before and up to 6 hours after intake of the supplement | Circulating Triglycerides assessed in plasma |
Countries
Netherlands
Outcome results
None listed