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Numerous evidences suggest an important role of short-chain fatty acids, produced by the intestinal fermentation of dietary fibers by the intestinal microbiota, in the modulation of various biological functions relevant to human health. In particular, butyrate, in addition to its trophic action on enterocytes, could improve insulin sensitivity and increase GLP-1 secretion, suggesting a possible role in the modulation of glucose metabolism. However, to date, very few randomized controlled trials (RCTs) have observed a significant increase in plasma butyrate concentrations in humans after nutritional interventions with high-fiber diets or foods. Butyrate occurs naturally in some foods, such as milk and dairy products, where it is often associated with sodium, becoming sodium butyrate. Therefore, recent studies suggest the use of oral sodium butyrate supplements in order to obtain a significant increase in butyrate plasma concentrations able to exert the potential beneficial effects related to them. To date, few studies have investigated the effect of oral sodium butyrate supplementation on glucose metabolism in healthy or overweight individuals, individuals at high cardiometabolic risk, and individuals with type 2 diabetes. Therefore, the purpose of this pilot study is to evaluate the effects of oral sodium butyrate supplementation, versus placebo, on glucose tolerance and insulin sensitivity in a group of overweight/obese individuals and the mechanisms underlying these effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral sodium-butyrrate supplementation | Experimental | Participants consumed 8 capsules of sodium butyrate per day for a week. The capsules were consumed with main meals (2 for breakfast, 2 for lunch and 2 for dinner). Each capsule contained 200 mg of sodium butyrate, for a total of 1.6 grams of sodium butyrate per day. |
|
| Placebo | Placebo Comparator | Participants consumed 8 capsules of placebo. The capsules were consumed with main meals (2 for breakfast, 2 for lunch and 2 for dinner). Each capsule contained cornstarch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplementation with sodium- butyrrate | Dietary Supplement | Oral supplementation with sodium butyrrate capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma glucose | The primary outcome of the study is the improvement of the glucose response during an oral glucose tolerance test (OGTT) after the supplementation with sodium butyrate, without changes in body weight | one week |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma insulin | The secondary outcome of the study is the improvement of the insulin response during an oral glucose tolerance test (OGTT) after the supplementation with sodium butyrate, without changes in body weightglycemic and insulinemic response during an OGTT separately in men and women | one week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Albarosa Rivellese, PO | Federico II University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federico II University, Department of Clinical Medicine and Surgery | Naples | 80131 | Italy |
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| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D050177 | Overweight |
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Placebo | Dietary Supplement | Oral supplementation with placebo capsules |
|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |