Maastricht University
Maastricht, Limburg, 5229 ER, Netherlands
Location status: Recruiting
NCT Number: NCT06384313
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.
Interested in participating?
Request Info20 year–70 year
All sexes
Interventional
Not applicable
Maastricht, Limburg, 5229 ER, Netherlands
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Exclusion criteria
The oils are consumed two times a day for 24 weeks (six months).
Time frame: Before and 6 months after the start of the intervention
The change of peripheral insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp
Time frame: Before and 6 months after the start of the intervention
The change in hepatic insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp
Time frame: Before and 6 months after the start of the intervention
The change in adipose tissue insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp
Time frame: Before and 6 months after the start of the intervention
The change in energy expenditure as measured via ventilated hood system
Time frame: Before and 6 months after the start of the intervention
The change in substrate oxidation as measured via ventilated hood system
Time frame: Before and 6 months after the start of the intervention
The change in concentrations of circulating SCFA
Time frame: Before and 6 months after the start of the intervention
The change in concentrations of faecal SCFA
Time frame: Before and 6 months after the start of the intervention
The change in faecal microbiota composition assessing abundances of bacteria and diversity indices as assessed via 16s rRNA gene
Time frame: Before and 6 months after the start of the intervention
The change in concentrations of circulating hormones in peripheral blood
Time frame: Before and 6 months after the start of the intervention
The change in concentrations of metabolites in peripheral blood
Time frame: Before and 6 months after the start of the intervention
The change in body composition as assessed using DEXA scans
Time frame: Before and 6 months after the start of the intervention
The change in body weight in kg using a weight scale
Time frame: Before and 6 months after the start of the intervention
The change in gut permeability as assessed using a multi-sugar test
Maastricht University Medical Center
Other
Prevention of Diabetes with a Novel Butyrate-enriched Triglyceride
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