obesity overweight
Conditions
Interventions
During the clinical investigation day, participants will ingest a liquid
high-fat mixed meal enriched with four different concentrations of a
butyrate/hexanoate-enriched oil:
1. Placebo: 0 mg butyr
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Overweight/obese men (BMI >= 25 kg/m2 and
Exclusion criteria
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
Secondary
| Measure | Time frame |
|---|---|
| - Circulating hormone concentrations (Insulin, GLP-1) - Circulating metabolite concentrations (Glucose, Free Fatty Acids, Glycerol and Triglycerides (TG)); - Circulating inflammatory markers (TNFa, IL1β, IL6 and IL8) - Appetite (Visual Analog Scales (VAS)-scoring system for hunger and satiety). - Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK). - Three-day food record. A three-day food record will be completed three days prior to each clinical investigation day. - Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. | — |
Primary
| Measure | Time frame |
|---|---|
| Primary parameters: The effects of acute supplementation of four different concentrations of butyrate/hexanoate-enriched oil on plasma SCFA availability Primary endpoint: Plasma SCFA concentrations. | — |
Countries
Netherlands
Outcome results
None listed