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| Name | Class |
|---|---|
| Top Institute Food and Nutrition | OTHER |
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An increased body mass impairs vascular function (VF), an important characteristic of subjects suffering from type 2 diabetes and a risk marker for cardiovascular diseases. However, a wide variety of in vivo VF markers exists each measuring different aspects of VF. Each of these markers addresses a different aspect of the vasculature. Studies comparing under standardized conditions the differences and relationships of the many different VF measurements in lean and abdominally overweight / obese subjects are missing. Also, there is a great need to know which of these markers are sensitive to dietary challenges.
Therefore, it is imperative to conduct an extensive study on dietary effects and interrelationships of a broad spectrum of VF measurements and plasma biomarkers in lean and overweight / obese subjects. Focus will be on FMD, a well accepted biomarker for cardiovascular disease. The investigators propose to examine, in a two-way parallel-randomized human intervention study, the effects of weight-loss in abdominally overweight / obese men on VF markers and plasma biomarkers related to low-grade inflammation and vascular activity during the fasting and both the postprandial and hyperinsulinemic state. Furthermore, differences - and relations between - VF measurements and plasma biomarkers will be compared cross-sectionally between lean and abdominally overweight / obese male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight-loss treatment | Experimental | A very-low energy diet (Modifast Intensive) for 4-5 weeks providing 2.1 MJ/day in order to reduce body weight. After 4-5 weeks a mixed solid energy-restricted diet up to 4.2 MJ/day with a recommended composition for the following 1-2 weeks. Then, a diet matching their energy requirements to maintain newly achieved body weights (weight-stable conditions) for at least 2 weeks. |
|
| No-weight loss treatment | Other | Maintenance of habitual diet and physical activity for 8 weeks to maintain body weights. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight-loss treatment | Other | A very-low energy diet (Modifast Intensive) for 4-5 weeks providing 2.1 MJ/day in order to reduce body weight. After 4-5 weeks a mixed solid energy-restricted diet up to 4.2 MJ/day with a recommended composition for the following 1-2 weeks. Then, a diet matching their energy requirements to maintain newly achieved body weights (weight-stable conditions) for at least 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Vascular activity: differences between lean and abdominally overweight / obese men and effects of weight loss | Flow-mediated dilation (FMD) of the brachial artery. | Difference after weight-loss due to restriction of energy intake for 8 weeks and change from baseline at 2 hours after meal consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Vascular function markers related to the macrovasculature: differences between lean and abdominally overweight / obese men and effects of weight loss | Carotid-wall intima-media thickness (IMT), carotid compliance and distensibility, pulse wave velocity and analysis (PWV and PWA) and peripheral artery tonometry (PAT). | Difference after weight-loss due to restriction of energy intake for 8 weeks and change from baseline during the postprandial (at 2 hours after meal consumption) / hyperinsulinemic state (at 2 hours after initiation of the clamp) |
| Measure | Description | Time Frame |
|---|---|---|
| Body fat components and fat content of intra-abdominal organs: differences between lean and abdominally overweight / obese men and effects of weight loss | Dixon MRI measurements in order to quantify abdominal fat compartments (i.e. subcutaneous and visceral fat) and fat content of abdominal organs (i.e. liver). | Difference after weight-loss due to restriction of energy intake for 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald P Mensink, PhD | Maastricht University Medical Center | Principal Investigator |
| Casper G Schalkwijk, PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33933731 | Derived | Van den Eynde MDG, Kusters YHAM, Houben AJHM, Scheijen JLJM, van Duynhoven J, Fazelzadeh P, Joris PJ, Plat J, Mensink RP, Hanssen NMJ, Stehouwer CDA, Schalkwijk CG. Diet-induced weight loss reduces postprandial dicarbonyl stress in abdominally obese men: Secondary analysis of a randomized controlled trial. Clin Nutr. 2021 May;40(5):2654-2662. doi: 10.1016/j.clnu.2021.03.042. Epub 2021 Apr 15. | |
| 31982191 |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| D001835 | Body Weight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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|
| No-weight loss treatment | Other | Maintenance of habitual diet and physical activity for 8 weeks to maintain body weights. |
|
| Vascular function markers related to the microvasculature: differences between lean and abdominally overweight / obese men and effects of weight loss | Capillary video microscopy of the finger skin, skin microvascular vasomotion, glycocalyx thickness, retina photography, skin auto fluorescence and contrast enhanced ultrasound (CEUS) in skeletal muscle. | Difference after weight-loss due to restriction of energy intake for 8 weeks and change from baseline during the postprandial (at 1 and 3 hours after meal consumption) / hyperinsulinemic state (at 2 hours after initiation of the clamp) |
| Metabolic risk markers related to the metabolic syndrome: differences between lean and abdominally overweight / obese men and effects of weight loss | Biomarkers for low-grade inflammation and endothelial activation. | Difference after weight-loss due to restriction of energy intake for 8 weeks and change from baseline during the postprandial (during 4 hours after meal consumption) / hyperinsulinemic state (during 3 hours after initiation of the clamp) |
| Blood pressure: difference between lean and abdominally overweight / obese men and effects of weight loss | 24-hr ambulatory blood pressure | Difference after weight-loss due to restriction of energy intake for 8 weeks |
| Derived |
| Joris PJ, Plat J, Kusters YHAM, Houben AJHM, Stehouwer CDA, Schalkwijk CG, Mensink RP. Effects of diet-induced weight loss on postprandial vascular function after consumption of a mixed meal: Results of a randomized controlled trial with abdominally obese men. Clin Nutr. 2020 Oct;39(10):2998-3004. doi: 10.1016/j.clnu.2020.01.006. Epub 2020 Jan 13. |
| 30830386 | Derived | Fazelzadeh P, Hoefsloot HCJ, Hankemeier T, Most J, Kersten S, Blaak EE, Boekschoten M, van Duynhoven J. Global testing of shifts in metabolic phenotype. Metabolomics. 2018 Oct 4;14(10):139. doi: 10.1007/s11306-018-1435-8. |
| 30753672 | Derived | Telgenkamp I, Kusters YHAM, Schalkwijk CG, Houben AJHM, Kooi ME, Lindeboom L, Bons JAP, Schaper NC, Joris PJ, Plat J, Mensink RP, Stehouwer CDA, Brouwers MCGJ. Contribution of Liver Fat to Weight Loss-Induced Changes in Serum Hepatokines: A Randomized Controlled Trial. J Clin Endocrinol Metab. 2019 Jul 1;104(7):2719-2727. doi: 10.1210/jc.2018-02378. |
| 29211893 | Derived | Schutten MTJ, Kusters YHAM, Houben AJHM, Scheijen JLJM, van de Waarenburg MPH, Schalkwijk CG, Joris PJ, Plat J, Mensink RP, de Leeuw PW, Stehouwer CDA. Aldosterone Is Not Associated With Metabolic and Microvascular Insulin Sensitivity in Abdominally Obese Men. J Clin Endocrinol Metab. 2018 Feb 1;103(2):759-767. doi: 10.1210/jc.2017-01541. |
| 28679946 | Derived | Kusters YH, Schalkwijk CG, Houben AJ, Kooi ME, Lindeboom L, Op 't Roodt J, Joris PJ, Plat J, Mensink RP, Barrett EJ, Stehouwer CD. Independent tissue contributors to obesity-associated insulin resistance. JCI Insight. 2017 Jul 6;2(13):e89695. doi: 10.1172/jci.insight.89695. eCollection 2017 Jul 6. |
| 27881395 | Derived | Joris PJ, Plat J, Kusters YH, Houben AJ, Stehouwer CD, Schalkwijk CG, Mensink RP. Diet-induced weight loss improves not only cardiometabolic risk markers but also markers of vascular function: a randomized controlled trial in abdominally obese men. Am J Clin Nutr. 2017 Jan;105(1):23-31. doi: 10.3945/ajcn.116.143552. Epub 2016 Nov 23. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |