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The MEDGICarb-Study...
The MEDGICarb-Study: Design of a multi-center randomized controlled trial to determine the differential health-promoting effects of low- and high-glycemic index Mediterranean-style eating patterns
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Bergia, Robert E. (author)
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- Biskup, I. (author)
- Chalmers tekniska högskola,Chalmers University of Technology
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- Giacco, Rosalba (author)
- Universita Degli Studi Di Napoli Federico Ii,University of Naples Federico II,Consiglo Nazionale Delle Richerche
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- Costabile, Giuseppina (author)
- Universita Degli Studi Di Napoli Federico Ii,University of Naples Federico II
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Gray, Savanna (author)
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Wright, Amy (author)
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- Vitale, Marilena (author)
- Universita Degli Studi Di Napoli Federico Ii,University of Naples Federico II
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Campbell, Wayne W. (author)
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- Landberg, Rikard, 1981 (author)
- Chalmers tekniska högskola,Chalmers University of Technology
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- Riccardi, Gabriele (author)
- Consiglo Nazionale Delle Richerche
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(creator_code:org_t)
- Elsevier BV, 2020
- 2020
- English.
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In: Contemporary Clinical Trials Communications. - : Elsevier BV. - 2451-8654. ; 19
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Abstract
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- Adults with central adiposity and other features of the metabolic syndrome have a markedly elevated risk of developing type 2 diabetes (T2D) and cardiovascular disease (CVD). A Mediterranean-style healthy eating pattern (MED-HEP) and consumption of foods with a lower glycemic index (GI) are potential dietary approaches to curb the T2D and CVD epidemic. However, experimental evidence of the effectiveness of MED-HEP and of the contribution of GI towards improving indices of glucose homeostasis, especially among non-diabetic people, are lacking. Therefore, we developed the MedGI-Carb trial, a multi-center (Italy, Sweden, and United States) intervention in adults with at least two components of the metabolic syndrome (elevated waist circumference + one other component) that aims to improve markers of glucose homeostasis through dietary modification. All participants were randomized to consume an isocaloric high- or low-GI MED-HEP for 12 weeks. We hypothesized that indexes of insulinemia (primary outcome: postprandial insulin and glucose after standardized breakfast and lunch; secondary outcomes: fasting plasma glucose and insulin, HbA1c, 24-h continuous glucose monitoring) would be improved more with the low-GI versus the high-GI MED-HEP. Additionally, we hypothesized that consumption of a MED-HEP would improve other markers of cardiometabolic health and well-being (fasting blood pressure, fasting lipid profile, sleep quality, satiety, global metabolic alterations in the plasma metabolome, changes in the gut microbiota, subjective health and well-being), with no difference between groups. Collectively, the design of MEDGI-Carb allows several different research questions to be explored. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03410719.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Annan klinisk medicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Other Clinical Medicine (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Näringslära (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Nutrition and Dietetics (hsv//eng)
Keyword
- Mediterranean diet
- Glycaemia
- Glucose control
- Insulinemia
- Cardiometabolic health
Publication and Content Type
- art (subject category)
- ref (subject category)
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- By the author/editor
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Bergia, Robert E ...
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Biskup, I.
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Giacco, Rosalba
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Costabile, Giuse ...
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Gray, Savanna
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Wright, Amy
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show more...
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Vitale, Marilena
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Campbell, Wayne ...
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Landberg, Rikard ...
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Riccardi, Gabrie ...
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Endocrinology an ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Other Clinical M ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Health Sciences
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and Nutrition and Di ...
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Contemporary Cli ...
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Chalmers University of Technology