Butyrate-enriched triglycerides for preventing diabetes
Prevention of Diabetes with a Novel Butyrate-enriched Triglyceride
This study is testing if eating special fats that contain butyrate and hexanoate can help people at risk for type 2 diabetes and obesity improve their metabolic health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT06384313 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of butyrate and hexanoate-enriched triglycerides on metabolic health in individuals at risk for type 2 diabetes and obesity. It is based on previous animal and observational studies suggesting that these short-chain fatty acids can improve body weight control, inflammation, and insulin resistance. Participants will consume the enriched triglycerides to assess whether chronic increases in butyrate and hexanoate levels can lead to long-term metabolic benefits. The study aims to determine the impact of these compounds on adipose tissue function and systemic lipid levels.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-70 with a BMI between 28 and 40 who are stable in weight and show signs of disturbed glucose or insulin homeostasis.
Not a fit: Patients with existing diabetes, cardiovascular disease, pulmonary disease, kidney or liver malfunction, or gastrointestinal disorders are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel dietary intervention for preventing type 2 diabetes and improving metabolic health.
How similar studies have performed: While there is promising evidence from animal and observational studies, this specific approach using butyrate and hexanoate-enriched triglycerides has not been extensively tested in human trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Age 20-70 years * BMI ≥ 28 and \< 40 kg/m2 * Weight stable for at least 3 months * Normal blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg) * One or more of the following criteria to determine disturbed glucose/insulin homeostasis * Fasting glucose 5.6-6.9 mmol/L * Two-hour glucose of 7.8-11.1 mmol/L * HOMA-IR ≥ 2.2 * HbA1c (5.7-6.4%) Exclusion Criteria: * Diabetes mellitus (type 1 or 2) * Cardiovascular disease: including no history or myocardial infarction, heart failure, arrhythmias * Pulmonary disease: no history of chronic obstructive pulmonary disease, emphysema, bronchitis, asthma * Kidney (e.g. kidney failure) or liver (e.g. cirrhosis, non-alcoholic fatty acid) malfunction * Gastrointestinal disease (no inflammatory bowel disease, irritable bowel syndrome or digestive disorders) or a history of abdominal surgery (except appendectomy and cholecystectomy) * Autoimmune disease * Any other diseases affecting glucose and/or lipid metabolism or use of any medication that influence glucose or fat metabolism and inflammation * Ongoing disease or any disease with a life expectancy ≤ 5 years * Abuse of products; alcohol (\>15 units per week) and drugs, excessive nicotine use defined as \>20 cigarettes per week * Regular supplementation of pre- or probiotic products, use of pre- or probiotics, antibiotics and laxatives 3 months prior to the start of the study * Intensive exercise training more than three hours a week * Plan to lose weight or to follow a hypocaloric diet or vegetarian diet * Pregnancy
Where this trial is running
Maastricht, Limburg
- Maastricht University — Maastricht, Limburg, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.