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| Name | Class |
|---|---|
| Top Institute Food and Nutrition | OTHER |
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Based on our hypothesis that orally administered GOS 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 a 12-week supplementation of GOS on peripheral insulin sensitivity and body weight control in obese adults with impaired glucose homeostasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galactooligosaccharide | Active Comparator | 5g 3x per day for 12 weeks |
|
| maltodextrin | Placebo Comparator | 3x per day for 12 weeks (isocaloric to intervention) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galactooligosaccharide | Dietary Supplement | The dietary fiber GOS will be supplemented in powder form to regular daily food intake three times per day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| systemic insulin sensitivity | change from baseline at 12 week supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| substrate oxidation and energy expenditure | change from baseline at 12 week supplementation | |
| plasma markers of substrate and energy metabolism | change from baseline at week 1 and at 12 week supplementation |
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Inclusion Criteria:
Overweight/obese (BMI ≥ 28 kg/m2 < 40 kg/m2) insulin impaired men and post-menopausal women with impaired glucose tolerance (IGT: 2h plasma glucose during 75g OGTT 7.8-11.1 mmol/l) and/or impaired fasting glucose (plasma glucose ≥ 5.6 mmol/l) aged 45-70 years will be included in the study.
In addition, subjects have to be weight-stable for at least 3 months prior to participation (no change in bodyweight, i.e. < 3kg).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen E Blaak | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Human Biology, Maastricht University Medical Centre | Maastricht | 6200MD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28396144 | Derived | Canfora EE, van der Beek CM, Hermes GDA, Goossens GH, Jocken JWE, Holst JJ, van Eijk HM, Venema K, Smidt H, Zoetendal EG, Dejong CHC, Lenaerts K, Blaak EE. Supplementation of Diet With Galacto-oligosaccharides Increases Bifidobacteria, but Not Insulin Sensitivity, in Obese Prediabetic Individuals. Gastroenterology. 2017 Jul;153(1):87-97.e3. doi: 10.1053/j.gastro.2017.03.051. Epub 2017 Apr 8. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C072242 | 4'-galactooligosaccharide |
| C008315 | maltodextrin |
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| maltodextrin | Dietary Supplement |
|
| fecal and plasma SCFA concentrations | change from baseline at week 1 and at 12 week supplementation |
| fecal microbiota composition | change from baseline at week 1 and at 12 week supplementation |
| skeletal muscle and adipose tissue gen and protein expression | change from baseline at week 1 and at 12 week supplementation |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |