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| Name | Class |
|---|---|
| Top Institute Food and Nutrition | OTHER |
| Center for Translational Molecular Medicine | OTHER |
A growing body of evidence demonstrates that increased adipose mass, especially visceral adipose tissue, contributes directly towards an increase in systemic inflammation, (micro-)vascular dysfunction and the burden of cardiovascular disease (CVD), insulin resistance and type 2 diabetes. Advanced glycation/lipoxidation endproducts (AGEs/ALEs) are a heterogeneous family of unavoidable by-products, which are formed by reactive metabolic intermediates derived from glucose and lipid oxidation. In addition to the overwhelming amount of data demonstrating the role of AGEs/ALEs in the development of (micro-)vascular dysfunction and disease, accumulation of AGEs/ALEs in the expanding adipose tissue contributes to the dysregulation of adipokines and the development of insulin resistance.
The investigators want to examine, in a double-blind randomized placebo controlled parallel study, the physiological effect of a dietary intervention with pyridoxamine in abdominally obese persons.
A sub-study is implemented next to the clinical trial. The objective of the sub-study is to measure the metabolization and kinetics of pyridoxamine in plasma and urine with UPLC-MS/MS. The sub-study comprises of 5 additional healthy volunteers, with pyridoxamine as an oral supplement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pyridoxamine (1) | Active Comparator | Subjects will be asked to consume dietary supplements containing pyridoxamine (dosage 1), three times daily during 8 weeks. |
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| Pyridoxamine (2) | Active Comparator | Subjects will be asked to consume dietary supplements containing pyridoxamine (dosage 2), three times daily during 8 weeks |
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| Placebo | Placebo Comparator | Subjects will be asked to consume dietary supplements containing placebo (amylum solani), three times daily during 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pyridoxamine | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | Assessed by hyperinsulinemic-euglycemic clamp | Difference after 8 weeks of intervention |
| Microvascular function | Assessed by contrast-enhanced ultrasound (CEUS) in skeletal muscle | Difference after 8 weeks of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Casper G Schalkwijk, PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | 6200MD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34229268 | Derived | Van den Eynde MDG, Scheijen JLJM, Stehouwer CDA, Miyata T, Schalkwijk CG. Quantification of the B6 vitamers in human plasma and urine in a study with pyridoxamine as an oral supplement; pyridoxamine as an alternative for pyridoxine. Clin Nutr. 2021 Jul;40(7):4624-4632. doi: 10.1016/j.clnu.2021.05.028. Epub 2021 Jun 10. |
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| ID | Term |
|---|---|
| C535554 | Abdominal obesity metabolic syndrome |
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| ID | Term |
|---|---|
| D011733 | Pyridoxamine |
| ID | Term |
|---|---|
| D025101 | Vitamin B 6 |
| D010847 | Picolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Dietary Supplement |
|
| D006571 |
| Heterocyclic Compounds |