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In this project the investigators intend to study the therapeutic potential of a personalized fibre mixture in individuals at high risk of developing T2DM, and aim to address the following key objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| isocaloric fermentable oligosaccaride | Active Comparator | isocaloric fermentable oligosaccaride |
|
| Personalized fiber mixture | Experimental | 12 g for 2 weeks, followed by 24 g for 10 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fermentable oligosaccharide | Dietary Supplement | Supplementation period 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral insulin sensitivity | The change of peripheral insulin sensitivity (m-value) as assessed by a hyperinsulinaemic-euglycemic clamp | Before and 12 week after the start of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Energy expenditure (indirect calorimetry) | The change in energy expenditure as measured via ventilated hood system | Before and 12 week after the start of the intervention |
| Substrate oxidation (indirect calorimetry) |
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Inclusion Criteria:
Overweight/obese insulin resistant/prediabetic participants (age 30-70 y, BMI ≥ 28 kg/m2 < 40 kg/m2)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Maastricht | Limburg | 5229ER | Netherlands |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Personalized fiber mixture | Dietary Supplement | Supplementation period 12 weeks |
|
The change in substrate oxidation as measured via ventilated hood system
| Before and 12 week after the start of the intervention |
| circulating SCFA | The change in concentrations of circulating SCFA | Before and 12 week after the start of the intervention |
| Faecal SCFA | The change in concentrations of faecal SCFA | Before and 12 week after the start of the intervention |
| Faecal microbiota composition and in vitro microbial activity testing | The change in faecal microbiota composition assessing abundances of bacteria and diversity indices as assessed via 16s rRNA gene | Before and 12 week after the start of the intervention |
| Circulating hormones such as insulin | The change in concentrations of circulating hormones in peripheral blood | Before and 12 week after the start of the intervention |
| Circulating metabolites such as glucose | The change in concentrations of metabolites in peripheral blood | Before and 12 week after the start of the intervention |
| body fat percentage | The change in body fat percentage as assessed using DEXA scans | Before and 12 week after the start of the intervention |
| fat mass | The change in fat mass in kg as assessed using DEXA scans | Before and 12 week after the start of the intervention |
| lean mass | The change in lean mass in kg as assessed using DEXA scans | Before and 12 week after the start of the intervention |
| visceral fat | The change in visceral fat in gram as assessed using DEXA scans | Before and 12 week after the start of the intervention |
| body weight | The change in body weight in kg using a weight scale | Before and 12 week after the start of the intervention |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |