Actively Recruiting
Prevention of Diabetes with a Novel Butyrate-enriched Triglyceride
Led by Maastricht University Medical Center · Updated on 2024-10-26
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether increasing levels of butyrate and hexanoate, two short-chain fatty acids (SCFAs), in the bloodstream can improve metabolism and help prevent diabetes in people who are overweight or obese and have prediabetes. Animal and human studies suggest these SCFAs have positive effects on body weight control, inflammation, and insulin resistance. This study aims to see if long-term increases in these SCFAs improve fat tissue function, reduce inflammation, and increase insulin sensitivity. Participants will be randomly assigned to receive either an oil enriched with butyrate and hexanoate triglycerides or a placebo oil without these SCFAs but otherwise similar in composition. The oils are taken twice daily for 24 weeks (six months). The study uses a double-blind design, meaning neither the participants nor the researchers know who receives which oil until the end of the trial. During the study, participants will undergo various assessments before and after the six-month intervention. These include tests for insulin sensitivity in peripheral tissue, liver, and fat tissue, energy expenditure and substrate oxidation measurements, blood and stool tests for SCFA levels and microbiota composition, hormone and metabolite analysis, body composition and weight checks, and gut permeability assessment. The total participation lasts at least six months, with continuous monitoring of metabolic health and safety.
CONDITIONS
Brief Title
Butyrate-enriched Triglyceride and Diabetes Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 to 70 years
- Body mass index (BMI) between 28 and less than 40 kg/m2
- Stable weight for at least 3 months
- Normal blood pressure (systolic 100-140 mmHg, diastolic 60-90 mmHg)
- Evidence of disturbed glucose or insulin regulation including one or more of: fasting glucose 5.6-6.9 mmol/L, two-hour glucose 7.8-11.1 mmol/L, HOMA-IR ≥ 2.2, or HbA1c 5.7-6.4%
You will not qualify if you...
- Diagnosis of diabetes mellitus type 1 or type 2
- History of cardiovascular disease including myocardial infarction, heart failure, or arrhythmias
- History of chronic pulmonary diseases such as COPD, emphysema, bronchitis, or asthma
- Kidney or liver malfunction including cirrhosis or non-alcoholic fatty liver disease
- Gastrointestinal diseases including inflammatory bowel disease, irritable bowel syndrome, digestive disorders, or history of abdominal surgery except appendectomy and cholecystectomy
- Autoimmune diseases
- Any diseases or medications affecting glucose or fat metabolism and inflammation
- Ongoing serious illness or life expectancy of 5 years or less
- Alcohol abuse (more than 15 units per week), drug abuse, or heavy smoking (more than 20 cigarettes per week)
- 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 hypocaloric or vegetarian diet
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants consume butyrate/hexanoate-enriched triglyceride oils or placebo twice daily.
1 baseline visit and 1 follow-up visit at 6 months
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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