Butyrate-enriched Triglyceride and Diabetes Prevention

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Apr 22, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a special oil enriched with two types of fatty acids, butyrate and hexanoate, can help prevent type 2 diabetes and improve metabolic health in individuals who are overweight or at risk for diabetes. The researchers believe that increasing levels of these fatty acids in the body could lead to better fat storage and reduced inflammation, which may help the body respond better to insulin—a hormone that regulates blood sugar levels.

To participate in the study, you need to be between 20 and 70 years old, have a body mass index (BMI) between 28 and 40, and have stable weight for at least three months. You should also show signs of glucose management issues, but cannot have diabetes or certain other medical conditions. If you qualify, you will help researchers understand the potential long-term benefits of this oil on your health. Participants can expect regular follow-ups and monitoring throughout the trial, and it’s an opportunity to contribute to important research aimed at preventing diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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%)
• Exclusion Criteria:
• • Diabetes mellitus (type 1 or 2)
• • Cardiovascular disease: including no history or myocardial infarction, heart failure, arrhythmias
• • Pulmonary disease: no history of chronic obstructive pulmonary disease, emphysema, bronchitis, asthma
• • Kidney (e.g. kidney failure) or liver (e.g. cirrhosis, non-alcoholic fatty acid) malfunction
• • Gastrointestinal disease (no inflammatory bowel disease, irritable bowel syndrome or digestive disorders) or a history of abdominal surgery (except appendectomy and cholecystectomy)
• • Autoimmune disease
• • Any other diseases affecting glucose and/or lipid metabolism or use of any medication that influence glucose or fat metabolism and inflammation
• • Ongoing disease or any disease with a life expectancy ≤ 5 years
• • Abuse of products; alcohol (\>15 units per week) and drugs, excessive nicotine use defined as \>20 cigarettes per week
• • Regular supplementation of pre- or probiotic products, use of pre- or probiotics, antibiotics and laxatives 3 months prior to the start of the study
• • Intensive exercise training more than three hours a week
• • Plan to lose weight or to follow a hypocaloric diet or vegetarian diet
• • Pregnancy