Butyrate/hexanoate-enriched triglycerides for metabolic health

Completed

• Conditions: obesity; overweight; 10003018

• Registration Number: NL-OMON49589
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary parameters:<br /><br>The effects of acute supplementation of four different concentrations of<br /><br>butyrate/hexanoate-enriched oil on plasma SCFA availability<br /><br><br /><br>Primary endpoint: Plasma SCFA concentrations.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Circulating hormone concentrations (Insulin, GLP-1)<br /><br>- Circulating metabolite concentrations (Glucose, Free Fatty Acids, Glycerol<br /><br>and Triglycerides (TG));<br /><br>- Circulating inflammatory markers (TNFa, IL1&beta;, IL6 and IL8)<br /><br>- Appetite (Visual Analog Scales (VAS)-scoring system for hunger and satiety).<br /><br>- Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK).<br /><br>- Three-day food record. A three-day food record will be completed three days<br /><br>prior to each clinical investigation day.<br /><br>- Gastrointestinal Symptom Rating Scale (GSRS) questionnaire.</p><br>