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The study investigators hypothesize (1) that the SCFA/acetate metabolism differs between metabolic phenotypes and (2) that using a mixture of fibres that differ in degree of polymerization and branching namely a resistant starch and a human-like milk oligosaccharide enhance the acetate availability in the distal colon and systemic circulation, consequently leading to its metabolic effects.
To study this, the investigators will supplement lean, normoglycaemic vs. overweight/obese, prediabetic men with the fibre mixture the day before the clinical investigation day (CID) and study during the CID its effects on fasting and postprandial substrate and energy metabolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 11.43 g (3 x 3.81 g) maltodextrin the day before the clinical investigation day |
|
| Human milk-like oligosaccharide alone | Active Comparator | 12 g (3 x 4 g) of the human milk-like oligosaccharide the day before the clinical investigation day |
|
| Human milk-like oligosaccharide and resistant starch | Experimental | 12 g (3 x 4 g) of the human milk-like oligosaccharide and 7.5g resistant starch (3 x 2.5 g) the day before the clinical investigation day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Milk Oligossaccharide | Dietary Supplement | The day before the CIDs, the participants receive the supplements 3x a day in randomized order |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma acetate concentrations. | During the clinical investigation day plasma acetate will be sampled | plasma acetate will be sampled during the CID before the consumption of a liquid high fat mixed meal |
| Plasma acetate concentrations. | During the clinical investigation day plasma acetate will be sampled | plasma acetate will be sampled during the CID at t=60 minutes after consumption of a liquid high fat mixed meal |
| Plasma acetate concentrations. | During the clinical investigation day plasma acetate will be sampled | plasma acetate will be sampled during the CID at t=120 minutes after consumption of a liquid high fat mixed meal |
| Plasma acetate concentrations. | During the clinical investigation day plasma acetate will be sampled | plasma acetate will be sampled during the CID at t=240 minutes after consumption of a liquid high fat mixed meal |
| Faecal acetate concentrations. | On the day of clinical investigation day, fecal acetate will be sampled | Fecal acetate will be sampled in the morning before the testday |
| Plasma butyrate concentrations. | During the clinical investigation day, plasma butyrate will be sampled | plasma butyrate will be sampled during the CID before the consumption of a liquid high fat mixed meal |
| Plasma butyrate concentrations. |
| Measure | Description | Time Frame |
|---|---|---|
| Energy expenditure, fat and carbohydrate oxidation | Energy expenditure, fat and carbohydrate oxidation will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands); | Indirect calorimetry will be measured before and for 4 hours after the consumption of the liquid high-fat mixed meal during the whole CID |
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Inclusion criteria:
Lean (BMI ≥ 20kg/m2 and ≤ 24.9kg/m2) healthy men aged 30 - 65 years
as well as
overweight/obese (BMI ≥ 25kg/m2 and ≤ 34.9kg/m2) prediabetic men aged between 30 - 65 years
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Maastricht | Limburg | 5229ER | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37529001 | Derived | Canfora EE, Vliex LMM, Wang T, Nauta A, Bouwman FG, Holst JJ, Venema K, Zoetendal EG, Blaak EE. 2'-fucosyllactose alone or combined with resistant starch increases circulating short-chain fatty acids in lean men and men with prediabetes and obesity. Front Nutr. 2023 Jul 17;10:1200645. doi: 10.3389/fnut.2023.1200645. eCollection 2023. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
| D000084922 | Resistant Starch |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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| Maltodextrin | Dietary Supplement | The day before the CIDs, the participants receive the supplements 3x a day in randomized order |
|
| Human Milk Oligossaccharide and resistant starch | Dietary Supplement | The day before the CIDs, the participants receive the supplements 3x a day in randomized order |
|
During the clinical investigation day, plasma butyrate will be sampled
| plasma butyrate will be sampled during the CID at t=60 after consumption of a liquid high fat mixed meal |
| Plasma butyrate concentrations. | During the clinical investigation day, plasma butyrate will be sampled | plasma butyrate will be sampled during the CID at t=120 after consumption of a liquid high fat mixed meal |
| Plasma butyrate concentrations. | During the clinical investigation day, plasma butyrate will be sampled | plasma butyrate will be sampled during the CID at t=240 minutes after consumption of a liquid high fat mixed meal |
| Fecal butyrate concentrations. | On the day of clinical investigation day, fecal butyrate will be sampled | Fecal butyrate will be sampled in the morning before the testday |
| Plasma propionate concentrations. | During the clinical investigation day, plasma propionate will be sampled | Plasma propionate will be sampled during the CID before the consumption of a liquid high fat mixed meal |
| Plasma propionate concentrations. | During the clinical investigation day, plasma propionate will be sampled | Plasma propionate will be sampled during the CID t=60 minutes after the consumption of a liquid high fat mixed meal |
| Plasma propionate concentrations. | During the clinical investigation day, plasma propionate will be sampled | Plasma propionate will be sampled during the CID t=120 minutes after the consumption of a liquid high fat mixed meal |
| Plasma propionate concentrations. | During the clinical investigation day, plasma propionate will be sampled | Plasma propionate will be sampled during the CID t=240 minutes after the consumption of a liquid high fat mixed meal |
| Faecal propionate concentrations. | On the day of clinical investigation day, fecal propionate will be sampled | Fecal propionate will be sampled in the morning before the testday |
| Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK). | Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK). | Breath H2 will be sampled during the CID before and at t=30, t=60, t=90, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal |
| Plasma glucose concentrations | Plasma glucose concentrations | Plasma glucose concentrations will be sampled during the CID before and t=0, t=30, t=60, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal |
| Plasma insulin concentrations | Plasma insulin concentrations | Plasma insulin concentrations will be sampled during the CID before and at t=0, t=30, t=60, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal |
| Plasma FFA concentrations | Plasma FFA concentrations | Plasma FFA concentrations will be sampled during the CID before and at t=0, t=30, t=60, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal |
| Faecal microbiota composition | Faecal microbiota composition will be assessed via16S rRNA gene sequencing | Faecal microbiota composition will be sampled in the morning before the testday |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| Macromolecular Substances |
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |