Butyrate-enriched Triglyceride and Diabetes Prevention

NCT06384313 | Recruiting

• 1 other identifier: NL86266.068.24
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; PreDiabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• hepatic insulin sensitivity

  Before and 6 months after the start of the intervention

• adipose tissue insulin sensitivity

  Before and 6 months after the start of the intervention

• Energy expenditure (indirect calorimetry)

  Before and 6 months after the start of the intervention

• Substrate oxidation (indirect calorimetry)

  Before and 6 months after the start of the intervention

• circulating SCFA

  Before and 6 months after the start of the intervention

Study Arms (2)

butyrate/hexanoate-enriched triglycerides

EXPERIMENTAL

Oil containing butyrate and hexanoate-enriched triglycerides

Dietary Supplement: butyrate/hexanoate-enriched triglycerides

placebo

PLACEBO COMPARATOR

Oil devoid of butyrate and hexanoate but with similar composition as the intervention oil

Dietary Supplement: butyrate/hexanoate-enriched triglycerides

Interventions

butyrate/hexanoate-enriched triglycerides DIETARY_SUPPLEMENT

The oils are consumed two times a day for 24 weeks (six months).

butyrate/hexanoate-enriched triglycerides; placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 5229 ER, Netherlands

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State; Obesity

Interventions

Butyrates

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: September 19, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)