Reduction of the Metabolic Syndrome in Navarra-Spain

NCT01087086 | Completed

• 1 other identifier: RESMENA-S
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome; Obesity; Diabetes; Cardiovascular Disease

Keywords

Metabolic syndrome; Oxidative stress; Proinflammatory state; Insulin resistance; Hypertension; Dyslipidemia; Mediterranean diet; Glycemic index; Hypocaloric diet; Hyperproteic diet; Macronutrient distribution; Antioxidant capacity of the diet; Crononutrition; Dietary and psychological support; Waist circumference

Outcome Measures

Primary Outcomes (3)

• 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: * Free fatty acids * Total cholesterol * HDL-cholesterol * LDL-cholesterol

  One year

• Glucose Profile

  To evaluate glucose improvements the following measurements will be taking into account: * Glucose * Insulin * HOMA

  One year

Secondary Outcomes (6)

• Inflammation state

  One year

• Oxidative stress

  One year

• Psychological tests

  January 2010-November 2011

• Peripheral neurotransmitters

  March-April 2013

• Epigenetics

  April 2012-July 2014

Study Arms (2)

Crononutrition

EXPERIMENTAL

Dietary pattern: * Personalized diet * Caloric restriction (-30% Total energy intake) * High adherence to the Mediterranean Diet * Macronutrient distribution (30% Protein, 40% Carbohydrates and 30% Fat) * Low glycemic index/load * Increased antioxidant capacity of the diet

Behavioral: Crononutrition

American Heart Association

PLACEBO COMPARATOR

Dietary pattern: * Personalized diet * Caloric diet (-30% Total energy intake) * Macronutrients distribution according to the American Heart Association (AHA) guidelines

Behavioral: American Heart Association

Interventions

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.

Also known as: RYTHMONUTRITION, METABOLIC SYNDROME, OBESITY, DIABETES, CARDIOVASCULAR DISEASE, RESMENA-S

Crononutrition

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.

Also known as: RESMENA-A

American Heart Association

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Both sexes: Male and Female
• Metabolic Syndrome according to the IDF(2005)criteria:
• Waist circumference cutoffs (male ≥94 cm or female ≥80 cm) plus any two of the following four factors:
• Fasting glucose ≥5.55 mmol/L or use of antidiabetic medication
• Systolic BP ≥130 mm Hg, diastolic BP ≥85 mm Hg, or use of antihypertensive medication
• Fasting triglycerides ≥1.7 mm/L; and HDL-C \<1.0 mm/L in men and \<1.3 mm/L in women or specific treatment for this lipid abnormality

You may not qualify if:

• Recent follow-up of diets designed for weight loss
• Unstable weight in the past 3 months
• Alcoholic and drug dependence
• Hormonal treatment
• No stable pharmacological treatment
• Eating-disordered behaviors
• Severe physical or mental disability
• Pregnancy
• Terminal disease
• Institutionalization

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Hospital of Navarra: collaborator

Study Sites (1)

University of Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (24)

• 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.

  PMID: 19816812 BACKGROUND

• 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.

  PMID: 19783122 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.

  PMID: 19766058 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.

  PMID: 19656442 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.

  PMID: 19457510 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.

  PMID: 18985060 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.

  PMID: 17970534 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.

  PMID: 19079872 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.

  PMID: 18702949 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.

  PMID: 18753667 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.

  PMID: 19176282 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.

  PMID: 19298202 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.

  PMID: 19246894 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.

  PMID: 18308431 BACKGROUND

• 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.

  PMID: 30026784 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.

  PMID: 26417268 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.

  PMID: 26197243 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.

  PMID: 25641909 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.

  PMID: 24762259 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.

  PMID: 24567125 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.

  PMID: 24314875 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.

  PMID: 24249967 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.

  PMID: 23406163 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.

  PMID: 21519726 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Diabetes Mellitus; Cardiovascular Diseases; Insulin Resistance; Hypertension; Dyslipidemias

Interventions

ANAPC16 protein, human; Adiposity; Heart Disease Risk Factors; American Heart Association

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endocrine System Diseases; Vascular Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena; Risk Factors; Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Causality; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health; Voluntary Health Agencies; Organizations, Nonprofit; Organizations; Health Care Economics and Organizations

Study Officials

• 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

  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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 15, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: November 1, 2011
• Last Updated: May 12, 2016

Record last verified: 2011-11

Locations

ES (1)