Clinical trial NCT04662411: Butyrate/Hexanoate in Metabolic Health
Official title: Butyrate/Hexanoate-enriched Triglycerides for Metabolic Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disease
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 14
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Plasma butyrate concentrations
timeFrame: Fasting and postprandial butyrate will be measured before and up to 6 hours after intake of the supplement
Secondary outcomes:
measure: Circulating Glucose
timeFrame: Fasting and postprandial glucose will be measured before and up to 6 hours after intake of the supplement
measure: Circulating Free Fatty Acids
timeFrame: Fasting and postprandial Free Fatty Acids will be measured before and up to 6 hours after intake of the supplement
measure: Circulating Glycerol
timeFrame: Fasting and postprandial Glycerol will be measured before and up to 6 hours after intake of the supplement
measure: Circulating Triglycerides (TG)
timeFrame: Fasting and postprandial TG will be measured before and up to 6 hours after intake of the supplement
measure: Circulating insulin
timeFrame: Fasting and postprandial insulin will be measured before and up to 6 hours after intake of the supplement
measure: Breath H2
timeFrame: Fasting and postprandial breath H2 will be measured before and up to 6 hours after intake of the supplement
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
References: