Prevention of Diabetes with a Novel Butyrate-enriched Triglyceride

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 70
Healthy Volunteers: t
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∙ 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%)

Locations
Other Locations
Netherlands
Maastricht University
RECRUITING
Maastricht
Time Frame
Start Date: 2024-09-19
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 48
Treatments
Experimental: butyrate/hexanoate-enriched triglycerides
Oil containing butyrate and hexanoate-enriched triglycerides
Placebo_comparator: placebo
Oil devoid of butyrate and hexanoate but with similar composition as the intervention oil
Related Therapeutic Areas
Sponsors
Leads: Maastricht University Medical Center

This content was sourced from clinicaltrials.gov