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NCT Number: NCT06384313

Butyrate-enriched Triglyceride and Diabetes Prevention

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Limburg, 5229 ER, Netherlands

Location status: Recruiting

Location contact

Emanuel Canfora

CONTACT

[email protected]

+31 43 3881 669

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

butyrate/hexanoate-enriched triglycerides

Dietary Supplement

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

Primary outcomes

  1. Peripheral insulin sensitivity

    Time frame: Before and 6 months after the start of the intervention

    The change of peripheral insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp

Secondary outcomes

  1. hepatic insulin sensitivity

    Time frame: Before and 6 months after the start of the intervention

    The change in hepatic insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp

  2. adipose tissue insulin sensitivity

    Time frame: Before and 6 months after the start of the intervention

    The change in adipose tissue insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp

  3. Energy expenditure (indirect calorimetry)

    Time frame: Before and 6 months after the start of the intervention

    The change in energy expenditure as measured via ventilated hood system

  4. Substrate oxidation (indirect calorimetry)

    Time frame: Before and 6 months after the start of the intervention

    The change in substrate oxidation as measured via ventilated hood system

  5. circulating SCFA

    Time frame: Before and 6 months after the start of the intervention

    The change in concentrations of circulating SCFA

  6. Faecal SCFA

    Time frame: Before and 6 months after the start of the intervention

    The change in concentrations of faecal SCFA

  7. Faecal microbiota composition

    Time frame: Before and 6 months after the start of the intervention

    The change in faecal microbiota composition assessing abundances of bacteria and diversity indices as assessed via 16s rRNA gene

  8. Circulating hormones such as insulin

    Time frame: Before and 6 months after the start of the intervention

    The change in concentrations of circulating hormones in peripheral blood

  9. Circulating metabolites such as glucose

    Time frame: Before and 6 months after the start of the intervention

    The change in concentrations of metabolites in peripheral blood

  10. body composition

    Time frame: Before and 6 months after the start of the intervention

    The change in body composition as assessed using DEXA scans

  11. body weight

    Time frame: Before and 6 months after the start of the intervention

    The change in body weight in kg using a weight scale

  12. Gut permeability

    Time frame: Before and 6 months after the start of the intervention

    The change in gut permeability as assessed using a multi-sugar test

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Prevention of Diabetes with a Novel Butyrate-enriched Triglyceride

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 25, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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