Beta Glucan and Acetate Production

Study Overview
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Brief Summary
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Based on our hypothesis that orally administered resistant starch and 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 Beta Glucan on Acetate Production and Human Substrate Metabolism

Conditions
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Pre Diabetes, Obesity

Intervention / Treatment
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* Dietary Supplement: beta glucan and resistant starch
* Dietary Supplement: Placebo
* Dietary Supplement: beta gluten


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> | Dietary Supplement: Placebo<br>* isocaloric maltodextrin before the CID<br>|
| Active Comparator: beta glucan<br> | Dietary Supplement: beta gluten<br>* 12 g beta gluten there day before the CID<br>|
| Experimental: beta glucan and Resistant Starch<br> | Dietary Supplement: beta glucan and resistant starch<br>* 12g 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 (before a high-fat mixed meal) | 
| Plasma acetate concentrations (microM) |  | four hours after a high fat mixed meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy expenditure (kJ/min) will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands) |  | at baseline and four hours after a high fat mixed meal | 
| fat oxidation (g/min) will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands) |  | at baseline and four hours after a high fat mixed meal | 
| carbohydrate oxidation (g/min) will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands) |  | at baseline and four hours after a high fat mixed meal | 
| Circulating hormone concentrations (Insulin, GLP-1, PYY) |  | at baseline and four hours after a high fat mixed meal | 
| Circulating metabolite concentrations (Glucose, Free Fatty Acids, Triglycerides) |  | at baseline and four hours after a high fat mixed meal | 
| Plasma glucose (mmol/L) |  | at baseline and four hours after a high fat mixed meal | 
| Free Fatty Acids (micromol/L) |  | at baseline and four hours after a high fat mixed meal | 
| Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK) |  | at baseline and four hours after a high fat mixed meal |