Inulin and Acetate Production and Human Substrate Metabolism

Study Overview
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Brief Summary
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Based on our hypothesis that orally administered resistant starch and inulin/beta glucan will be fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective: To investigate the effects of an acute administration of inulin/beta glucan in combination with resistant starch on fecal and plasma acetate, as well as on fasting and postprandial substrate and energy metabolism in lean normoglycemic men and obese, prediabetic men.

Official Title
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The Effects of Inulin on Acetate Production and Human Substrate Metabolism

Conditions
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Obesity, Pre Diabetes

Intervention / Treatment
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* Dietary Supplement: Inulin and Resistant Starch
* Dietary Supplement: Inulin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: lean (BMI ≥ 20kg/m2 and ≤ 24.9kg/m2) normoglycemic aged 30 - 65 years OR overweight/obese (BMI ≥ 25kg/m2 and ≤ 34.9kg/m2) pre-diabetes aged between 30 - 65 years. Exclusion Criteria: diabetes mellitus gastroenterological diseases or major abdominal surgery (allowed i.e.: - appendectomy, cholecystectomy) lactose intolerance and other digestive disorders cardiovascular disease, cancer, liver or kidney malfunction (determined -based on ALAT and creatinine levels, respectively) disease with a life expectancy shorter than 5 years Use of antibiotics 3 months prior inclusion Use of probiotics or prebiotics

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>isocaloric maltodextrin the day before CIDs | Dietary Supplement: Placebo<br>* isocaloric maltodextrin before test day<br>|
| Active Comparator: Inulin<br>12 g of inulin + isocaloric maltodextrin the day before CID | Dietary Supplement: Inulin<br>* 12g per inulin in combination with maltodextrin per day the day before the CID<br>|
| Experimental: Inulin and Resistant Starch<br>12 g inulin + 7.5 g resistant starch the day before CID | Dietary Supplement: Inulin and Resistant Starch<br>* 12g per inulin in combination 7.5 g resistant starch per day the day before the CID Resistant starch 7.5 g<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma acetate concentrations (microM) |  | At baseline and up to four hours after a high-fat mixed meal of each CID | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy expenditure (in kJ/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands) |  | At baseline and up to four hours after a high-fat mixed meal of each CID | 
| Fat oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands) |  | At baseline and up to four hours after a high-fat mixed meal of each CID | 
| Carbohydrate oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands) |  | At baseline and up to four hours after a high-fat mixed meal of each CID | 
| Circulating hormone concentrations (Insulin, GLP-1, PYY) |  | At baseline and up to four hours after a high-fat mixed meal of each CID | 
| Circulating metabolite concentrations (Glucose, Free Fatty Acids, Triglycerides) |  | At baseline and up to four hours after a high-fat mixed meal of each CID | 
| Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK) |  | At baseline and up to four hours after a high-fat mixed meal of each CID |