Butyrate-enriched Triglyceride and Diabetes Prevention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: butyrate/hexanoate-enriched triglycerides.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes, PreDiabetes, Obesity. Basic parameters: 20 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prevention of Diabetes with a Novel Butyrate-enriched Triglyceride
Overview
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.
Interventions
- Dietary supplement butyrate/hexanoate-enriched triglycerides
The oils are consumed two times a day for 24 weeks (six months).
Primary outcome measures
- Peripheral insulin sensitivity [Time frame: Before and 6 months after the start of the intervention]
Secondary outcome measures (12)
- hepatic insulin sensitivity [Time frame: Before and 6 months after the start of the intervention]
- adipose tissue insulin sensitivity [Time frame: Before and 6 months after the start of the intervention]
- Energy expenditure (indirect calorimetry) [Time frame: Before and 6 months after the start of the intervention]
- Substrate oxidation (indirect calorimetry) [Time frame: Before and 6 months after the start of the intervention]
- circulating SCFA [Time frame: Before and 6 months after the start of the intervention]
- Faecal SCFA [Time frame: Before and 6 months after the start of the intervention]
- Faecal microbiota composition [Time frame: Before and 6 months after the start of the intervention]
- Circulating hormones such as insulin [Time frame: Before and 6 months after the start of the intervention]
- Circulating metabolites such as glucose [Time frame: Before and 6 months after the start of the intervention]
- body composition [Time frame: Before and 6 months after the start of the intervention]
- body weight [Time frame: Before and 6 months after the start of the intervention]
- Gut permeability [Time frame: Before and 6 months after the start of the intervention]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
Netherlands · 1 center
- Maastricht University — Maastricht
Identifiers
NCT: NCT06384313 · NL86266.068.24