Actively Recruiting
Butyrate-enriched Triglyceride and Diabetes Prevention
Led by Maastricht University Medical Center · Updated on 2024-10-26
48
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Butyrate-enriched Triglyceride and Diabetes Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20-70 years
- Body mass index (BMI) between 28 and less than 40 kg/m2
- Body weight stable for at least 3 months
- Normal blood pressure with systolic 100-140 mmHg and diastolic 60-90 mmHg
- One or more signs of disturbed glucose or insulin homeostasis: fasting glucose 5.6-6.9 mmol/L, two-hour glucose 7.8-11.1 mmol/L, HOMA-IR greater than or equal to 2.2, or HbA1c between 5.7% and 6.4%
You will not qualify if you...
- Diabetes mellitus type 1 or 2
- History of cardiovascular disease including myocardial infarction, heart failure, or arrhythmias
- History of pulmonary diseases such as chronic obstructive pulmonary disease, emphysema, bronchitis, or asthma
- Kidney or liver malfunction including kidney failure, cirrhosis, or non-alcoholic fatty liver disease
- Gastrointestinal diseases such as inflammatory bowel disease, irritable bowel syndrome, digestive disorders, or history of abdominal surgery except appendectomy and cholecystectomy
- Autoimmune disease
- Any disease affecting glucose or lipid metabolism or use of medication influencing these or inflammation
- Any ongoing disease or disease with life expectancy less than or equal to 5 years
- Abuse of alcohol (more than 15 units per week), drugs, or excessive nicotine use (more than 20 cigarettes per week)
- Regular use of pre- or probiotic supplements, antibiotics, or laxatives within 3 months before the study
- Intensive exercise training more than 3 hours per week
- Plans to lose weight or follow a low-calorie or vegetarian diet
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Maastricht University
Maastricht, Limburg, Netherlands, 5229 ER
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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