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| Name | Class |
|---|---|
| Hospital of Navarra | OTHER |
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The purpose of this study is to determine whether a dietary pattern based on crononutrition and dietary training, together with dietary and psychological control, can reduce the body weight, improve the oxidative and inflammatory state in subjects with diagnosed metabolic syndrome features and can reduce the prevalence of the Metabolic syndrome in the population.
The dietary pattern that characterizes the present nutritional intervention study is based on personalized diet, by elaborating tailoring-diets for each subject regarding his energetic needs and assuring a high adherence to the Mediterranean Diet. Moreover, the diet to be performed will be a hyperproteic diet to guarantee a satiety effect and a lower recovery of the lost weight, in accordance with the results derived from the main European study about nutrition (DIOGENES). The glycemic index/load will be also controlled in the study diet. The increase of the antioxidant capacity of the diet will be increased by the intake of fruits, walnuts and virgin olive oil among other antioxidant containing foods.
The present initiative, based on the traditional diet, aims to integrate the main results obtained from diverse observational epidemiological studies and interventional studies in the dietary pattern of the present study. At the same time, the study will apply the concept of crononutrition by selecting and distributing the foods thorough the day according the physiological needs of each individual.
In addition to the quantitative and qualitative composition of the diet, the study will take into account other important factors such as the behavior habits regarding the food, the frequency of consumption, the size of the eating portions, the distribution of the portions along the day, the feeling of fullness, the eating speed and so on. The aforementioned factors have recently been shown to be related to the gain of weight.
Other non dietary factors, such as smoking habits, sedentary life, socio-economic level, will be also controlled in the present study. Moreover, the project will integrate the dietary support together with psychological support due to the fact that the state of mind has been shown to be associated with the MS in some scientific publications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crononutrition | Experimental | Dietary pattern:
|
|
| American Heart Association | Placebo Comparator | Dietary pattern:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crononutrition | Behavioral | After the recruitment and selection of the study participants, the study will consists of a 2-month nutritional intervention (Crononutrition versus AHA) followed by second 6-month period ("autonomy phase") in which the subjects of the study will continue with their ruled dietary patterns, but without any dietary or psychological support. |
| Measure | Description | Time Frame |
|---|---|---|
| Body fat | Through this specific nutritional intervention program we will try to reduce the metabolic syndrome features such as waist circumference, body weight and adiposity. To evaluate the body composition, bioimpedance, DEXA and anthropometry methodology will be used at the beginning and after two months of intervention. | One year |
| Lipid profile | To evaluate lipid improvements the following measurements will be taking into account:
| One year |
| Glucose Profile | To evaluate glucose improvements the following measurements will be taking into account:
| One year |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation state | As secondary outcome some inflammatory markers will be analyzed:
| One year |
| Oxidative stress | As secondary outcome some oxidative stress markers will be analyzed:
|
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Inclusion Criteria:
Waist circumference cutoffs (male ≥94 cm or female ≥80 cm) plus any two of the following four factors:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| María Ángeles MA Zulet, PhD | University of Navarra | Principal Investigator |
| José Alfredo JA Martínez, PhD, RN | University of Navarra | Study Director |
| Itziar I Abete, PhD | University of Navarra | Study Chair |
| Lluis L Forga, PhD | Hospital of Navarra | Study Chair |
| Blanca Esther BE Martínez de Morentin, MD | University of Navarra | Study Chair |
| Santiago S Navas-Carretero, PhD | University of Navarra | Study Chair |
| Rocío R de la Iglesia, M.Sc | University of Navarra | Study Chair |
| Patricia P López Legarrea, M.Sc | University of Navarra | Study Chair |
| Isabel I Bondia-Pons, PhD | University of Navarra | Study Chair |
| Aurora A Perez Cornago, M.Sc |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Navarra | Pamplona | Navarre | 31008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19816812 | Background | Hermsdorff HH, Zulet MA, Abete I, Martinez JA. Discriminated benefits of a Mediterranean dietary pattern within a hypocaloric diet program on plasma RBP4 concentrations and other inflammatory markers in obese subjects. Endocrine. 2009 Dec;36(3):445-51. doi: 10.1007/s12020-009-9248-1. | |
| 19783122 | Background |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D002318 | Cardiovascular Diseases |
| D007333 | Insulin Resistance |
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C539689 | ANAPC16 protein, human |
| D050154 | Adiposity |
| D000082742 | Heart Disease Risk Factors |
| D000572 | American Heart Association |
| ID | Term |
|---|---|
| D050218 | Body Fat Distribution |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
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|
|
| American Heart Association | Behavioral | After the recruitment and selection of the study participants, the study will consists of a 2-month nutritional intervention (Crononutrition versus AHA) followed by second 6-month period ("autonomy phase") in which the subjects of the study will continue with their ruled dietary patterns, but without any dietary or psychological support. |
|
|
| One year |
| Psychological tests |
| January 2010-November 2011 |
| Peripheral neurotransmitters |
| March-April 2013 |
| Epigenetics |
| April 2012-July 2014 |
| Fatty Liver biomarkers / Non invasive liver scoring system. | Measurements in fatty liver biomarkers: Serum transaminases (AST & ALT (U/L)), GGT (U/L) and CK18 (U/L) concentrations will be measured in a fasting state at the beginning, at 2 months and at the end of the intervention. - A specificif Fatty Liver Index was calculated at the begining, at 2 months and at the end of the intervention. | May 2016- January 2017 |
| University of Navarra |
| Study Chair |
| José Luiz JL Marques-Rocha, M.Sc | Universidade Federal de Viçosa | Study Chair |
| Marcos M García-Lacarte, M.Sc | University of Navarra | Study Chair |
| Irene I Cantero, M.Sc | University of Navarra | Study Chair |
| Puchau B, Zulet MA, de Echavarri AG, Hermsdorff HH, Martinez JA. Dietary total antioxidant capacity is negatively associated with some metabolic syndrome features in healthy young adults. Nutrition. 2010 May;26(5):534-41. doi: 10.1016/j.nut.2009.06.017. Epub 2009 Sep 26. |
| 19766058 | Background | Perez-Matute P, Zulet MA, Martinez JA. Reactive species and diabetes: counteracting oxidative stress to improve health. Curr Opin Pharmacol. 2009 Dec;9(6):771-9. doi: 10.1016/j.coph.2009.08.005. Epub 2009 Sep 18. |
| 19656442 | Background | Toledo E, de A Carmona-Torre F, Alonso A, Puchau B, Zulet MA, Martinez JA, Martinez-Gonzalez MA. Hypothesis-oriented food patterns and incidence of hypertension: 6-year follow-up of the SUN (Seguimiento Universidad de Navarra) prospective cohort. Public Health Nutr. 2010 Mar;13(3):338-49. doi: 10.1017/S1368980009991066. Epub 2009 Aug 6. |
| 19457510 | Background | Sotos-Prieto M, Zulet MA, Corella D. [Scientific evidence of the mediterranean diet effects in determining intermediate and final cardiovascular disease phenotypes]. Med Clin (Barc). 2010 Jan 23;134(1):22-9. doi: 10.1016/j.medcli.2009.01.033. Epub 2009 May 19. Spanish. |
| 18985060 | Background | Puchau B, Zulet MA, Gonzalez de Echavarri A, Navarro-Blasco I, Martinez JA. Selenium intake reduces serum C3, an early marker of metabolic syndrome manifestations, in healthy young adults. Eur J Clin Nutr. 2009 Jul;63(7):858-64. doi: 10.1038/ejcn.2008.48. Epub 2008 Nov 5. |
| 17970534 | Background | Zulet MA, Puchau B, Navarro C, Marti A, Martinez JA. [Inflammatory biomarkers: the link between obesity and associated pathologies]. Nutr Hosp. 2007 Sep-Oct;22(5):511-27. Spanish. |
| 19079872 | Background | Abete I, Parra MD, Zulet MA, Martinez JA. Different dietary strategies for weight loss in obesity: role of energy and macronutrient content. Nutr Res Rev. 2006 Jun;19(1):5-17. doi: 10.1079/NRR2006112. |
| 18702949 | Background | Martinez MA, Puig JG, Mora M, Aragon R, O'Dogherty P, Anton JL, Sanchez-Villares T, Rubio JM, Rosado J, Torres R, Marcos J, Pallardo LF, Banegas JR; MAPA (Monitorizacion Ambulatoria de la Presion Arterial) Working Group. Metabolic syndrome: prevalence, associated factors, and C-reactive protein: the MADRIC (MADrid RIesgo Cardiovascular) Study. Metabolism. 2008 Sep;57(9):1232-40. doi: 10.1016/j.metabol.2008.04.017. |
| 18753667 | Background | Sanchez-Chaparro MA, Calvo-Bonacho E, Gonzalez-Quintela A, Fernandez-Labandera C, Cabrera M, Sainz JC, Fernandez-Meseguer A, Banegas JR, Ruilope LM, Valdivielso P, Roman-Garcia J; Ibermutuamur Cardiovascular Risk Assessment (ICARIA) Study Group. Occupation-related differences in the prevalence of metabolic syndrome. Diabetes Care. 2008 Sep;31(9):1884-5. doi: 10.2337/dc08-0431. Epub 2008 Jun 20. |
| 19176282 | Background | Babio N, Bullo M, Basora J, Martinez-Gonzalez MA, Fernandez-Ballart J, Marquez-Sandoval F, Molina C, Salas-Salvado J; Nureta-PREDIMED Investigators. Adherence to the Mediterranean diet and risk of metabolic syndrome and its components. Nutr Metab Cardiovasc Dis. 2009 Oct;19(8):563-70. doi: 10.1016/j.numecd.2008.10.007. Epub 2009 Jan 26. |
| 19298202 | Background | Abete I, Parra D, Martinez JA. Legume-, fish-, or high-protein-based hypocaloric diets: effects on weight loss and mitochondrial oxidation in obese men. J Med Food. 2009 Feb;12(1):100-8. doi: 10.1089/jmf.2007.0700. |
| 19246894 | Background | Goyenechea E, Parra D, Crujeiras AB, Abete I, Martinez JA. A nutrigenomic inflammation-related PBMC-based approach to predict the weight-loss regain in obese subjects. Ann Nutr Metab. 2009;54(1):43-51. doi: 10.1159/000205319. Epub 2009 Feb 27. |
| 18308431 | Background | Abete I, Parra D, Martinez JA. Energy-restricted diets based on a distinct food selection affecting the glycemic index induce different weight loss and oxidative response. Clin Nutr. 2008 Aug;27(4):545-51. doi: 10.1016/j.clnu.2008.01.005. Epub 2008 Mar 4. |
| 30026784 | Derived | Cantero I, Abete I, Del Bas JM, Caimari A, Arola L, Zulet MA, Martinez JA. Changes in lysophospholipids and liver status after weight loss: the RESMENA study. Nutr Metab (Lond). 2018 Jul 17;15:51. doi: 10.1186/s12986-018-0288-5. eCollection 2018. |
| 26417268 | Derived | de la Iglesia R, Mansego ML, Sanchez-Muniz FJ, Zulet MA, Martinez JA. Arylesterase activity is associated with antioxidant intake and paraoxonase-1 (PON1) gene methylation in metabolic syndrome patients following an energy restricted diet. EXCLI J. 2014 Apr 9;13:416-26. eCollection 2014. |
| 26197243 | Derived | Garcia-Lacarte M, Milagro FI, Zulet MA, Martinez JA, Mansego ML. LINE-1 methylation levels, a biomarker of weight loss in obese subjects, are influenced by dietary antioxidant capacity. Redox Rep. 2016 Mar;21(2):67-74. doi: 10.1179/1351000215Y.0000000029. Epub 2016 Feb 15. |
| 25641909 | Derived | Bondia-Pons I, Martinez JA, de la Iglesia R, Lopez-Legarrea P, Poutanen K, Hanhineva K, Zulet Mde L. Effects of short- and long-term Mediterranean-based dietary treatment on plasma LC-QTOF/MS metabolic profiling of subjects with metabolic syndrome features: The Metabolic Syndrome Reduction in Navarra (RESMENA) randomized controlled trial. Mol Nutr Food Res. 2015 Apr;59(4):711-28. doi: 10.1002/mnfr.201400309. Epub 2015 Feb 5. |
| 24762259 | Derived | Perez-Cornago A, de la Iglesia R, Lopez-Legarrea P, Abete I, Navas-Carretero S, Lacunza CI, Lahortiga F, Martinez-Gonzalez MA, Martinez JA, Zulet MA. A decline in inflammation is associated with less depressive symptoms after a dietary intervention in metabolic syndrome patients: a longitudinal study. Nutr J. 2014 Apr 24;13:36. doi: 10.1186/1475-2891-13-36. |
| 24567125 | Derived | Lopez-Legarrea P, de la Iglesia R, Crujeiras AB, Pardo M, Casanueva FF, Zulet MA, Martinez JA. Higher baseline irisin concentrations are associated with greater reductions in glycemia and insulinemia after weight loss in obese subjects. Nutr Diabetes. 2014 Feb 24;4(2):e110. doi: 10.1038/nutd.2014.7. |
| 24314875 | Derived | Perez-Cornago A, Lopez-Legarrea P, de la Iglesia R, Lahortiga F, Martinez JA, Zulet MA. Longitudinal relationship of diet and oxidative stress with depressive symptoms in patients with metabolic syndrome after following a weight loss treatment: the RESMENA project. Clin Nutr. 2014 Dec;33(6):1061-7. doi: 10.1016/j.clnu.2013.11.011. Epub 2013 Nov 22. |
| 24249967 | Derived | Lopez-Legarrea P, Mansego ML, Zulet MA, Martinez JA. SERPINE1, PAI-1 protein coding gene, methylation levels and epigenetic relationships with adiposity changes in obese subjects with metabolic syndrome features under dietary restriction. J Clin Biochem Nutr. 2013 Nov;53(3):139-44. doi: 10.3164/jcbn.13-54. Epub 2013 Oct 31. |
| 23406163 | Derived | Lopez-Legarrea P, de la Iglesia R, Abete I, Bondia-Pons I, Navas-Carretero S, Forga L, Martinez JA, Zulet MA. Short-term role of the dietary total antioxidant capacity in two hypocaloric regimes on obese with metabolic syndrome symptoms: the RESMENA randomized controlled trial. Nutr Metab (Lond). 2013 Feb 13;10(1):22. doi: 10.1186/1743-7075-10-22. |
| 21519726 | Derived | Zulet MA, Bondia-Pons I, Abete I, de la Iglesia R, Lopez-Legarrea P, Forga L, Navas-Carretero S, Martinez JA. The reduction of the metabolyc syndrome in Navarra-Spain (RESMENA-S) study: a multidisciplinary strategy based on chrononutrition and nutritional education, together with dietetic and psychological control. Nutr Hosp. 2011 Jan-Feb;26(1):16-26. |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D001823 | Body Composition |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D008660 | Metabolism |
| D010829 | Physiological Phenomena |
| D012307 | Risk Factors |
| D012306 | Risk |
| D011336 | Probability |
| D013223 | Statistics as Topic |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D015984 | Causality |
| D015981 | Epidemiologic Factors |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D014837 | Voluntary Health Agencies |
| D009939 | Organizations, Nonprofit |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |