Butyrate-enriched Triglyceride and Diabetes Prevention

Obesity Clinical Trial

Official title:

Prevention of Diabetes With a Novel Butyrate-enriched Triglyceride

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384313
• Other study ID #: NL86266.068.24
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: September 1, 2027

Study information

• Verified date: April 2024
• Source: Maastricht University Medical Center
• Contact: Emanuel E Canfora, PhD
• Phone: 01733061283
• Email: e.canfora[@]freenet.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity
• PreDiabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

Dietary Supplement:
• butyrate/hexanoate-enriched triglycerides
The oils are consumed two times a day for 24 weeks (six months).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral insulin sensitivity	The change of peripheral insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp	Before and 6 months after the start of the intervention
Secondary	hepatic insulin sensitivity	The change in hepatic insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp	Before and 6 months after the start of the intervention
Secondary	adipose tissue insulin sensitivity	The change in adipose tissue insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp	Before and 6 months after the start of the intervention
Secondary	Energy expenditure (indirect calorimetry)	The change in energy expenditure as measured via ventilated hood system	Before and 6 months after the start of the intervention
Secondary	Substrate oxidation (indirect calorimetry)	The change in substrate oxidation as measured via ventilated hood system	Before and 6 months after the start of the intervention
Secondary	circulating SCFA	The change in concentrations of circulating SCFA	Before and 6 months after the start of the intervention
Secondary	Faecal SCFA	The change in concentrations of faecal SCFA	Before and 6 months after the start of the intervention
Secondary	Faecal microbiota composition	The change in faecal microbiota composition assessing abundances of bacteria and diversity indices as assessed via 16s rRNA gene	Before and 6 months after the start of the intervention
Secondary	Circulating hormones such as insulin	The change in concentrations of circulating hormones in peripheral blood	Before and 6 months after the start of the intervention
Secondary	Circulating metabolites such as glucose	The change in concentrations of metabolites in peripheral blood	Before and 6 months after the start of the intervention
Secondary	body composition	The change in body composition as assessed using DEXA scans	Before and 6 months after the start of the intervention
Secondary	body weight	The change in body weight in kg using a weight scale	Before and 6 months after the start of the intervention
Secondary	Gut permeability	The change in gut permeability as assessed using a multi-sugar test	Before and 6 months after the start of the intervention