NCT06384313

Butyrate-enriched Triglyceride and Diabetes Prevention

Prevention of Diabetes with a Novel Butyrate-enriched Triglyceride

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

Summary

A body of animal studies as well as observational studies in humans demonstrated that butyrate is one SCFA that has pronounced positive effects on body weight control, inflammation, and insulin resistance. Even though the SCFA hexanoate is less researched, it has been shown to be involved in anti-inflammatory processes. Of note, acute human studies showed that fibre-induced metabolic improvements are linked to higher SCFA levels in the systemic circulation. It has been shown that a butyrate/hexanoate-enriched triglyceride oil enhanced systemic butyrate and hexanoate concentrations for a prolonged time. Yet, it remains to be determined whether a chronic increase in circulating butyrate and hexanoate concentrations translate into long-term benefits. In this study it is hypothesized that a chronic increase of butyrate/hexanoate in the circulation may improve host metabolism and metabolic health by improving adipose tissue function, reducing systemic lipid overflow and inflammation thereby increasing peripheral insulin sensitivity in individual with overweight/obesity and prediabetes.

Conditions

• Type 2 Diabetes
• PreDiabetes
• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	butyrate/hexanoate-enriched triglycerides	The oils are consumed two times a day for 24 weeks (six months).

Timeline

• Start date: 2024-09-19
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2024-04-25
• Last updated: 2024-10-26

Locations

1 site across 1 country: Netherlands