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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| butyrate/hexanoate-enriched triglycerides | Experimental | Oil containing butyrate and hexanoate-enriched triglycerides |
|
| placebo | Placebo Comparator | Oil devoid of butyrate and hexanoate but with similar composition as the intervention oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| butyrate/hexanoate-enriched triglycerides | Dietary Supplement | The oils are consumed two times a day for 24 weeks (six months). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| adipose tissue insulin sensitivity |
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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
Exclusion Criteria:
Diabetes mellitus (type 1 or 2)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Recruiting | Maastricht | Limburg | 5229 ER | Netherlands |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D011236 | Prediabetic State |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002087 | Butyrates |
| ID | Term |
|---|---|
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
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The change in adipose tissue insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp
| Before and 6 months after the start of the intervention |
| 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 |
| 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 |
| circulating SCFA | The change in concentrations of circulating SCFA | Before and 6 months after the start of the intervention |
| Faecal SCFA | The change in concentrations of faecal SCFA | Before and 6 months after the start of the intervention |
| 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 |
| 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 |
| Circulating metabolites such as glucose | The change in concentrations of metabolites in peripheral blood | Before and 6 months after the start of the intervention |
| body composition | The change in body composition as assessed using DEXA scans | Before and 6 months after the start of the intervention |
| body weight | The change in body weight in kg using a weight scale | Before and 6 months after the start of the intervention |
| Gut permeability | The change in gut permeability as assessed using a multi-sugar test | Before and 6 months after the start of the intervention |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |