Reduction of the Metabolic Syndrome in Navarra-Spain

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

Interventions

BEHAVIORAL

Crononutrition

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.

BEHAVIORAL

American Heart Association

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.

Sponsors & Collaborators

• Hospital of Navarra

  collaborator OTHER

• Clinica Universidad de Navarra, Universidad de Navarra

  lead OTHER

Principal Investigators

• María Ángeles MA Zulet, PhD · University of Navarra

• José Alfredo JA Martínez, PhD, RN · University of Navarra

• Itziar I Abete, PhD · University of Navarra

• Lluis L Forga, PhD · Hospital of Navarra

• Blanca Esther BE Martínez de Morentin, MD · University of Navarra

• Santiago S Navas-Carretero, PhD · University of Navarra

• Rocío R de la Iglesia, M.Sc · University of Navarra

• Patricia P López Legarrea, M.Sc · University of Navarra

• Isabel I Bondia-Pons, PhD · University of Navarra

• Aurora A Perez Cornago, M.Sc · University of Navarra

• José Luiz JL Marques-Rocha, M.Sc · Universidade Federal de Viçosa

• Marcos M García-Lacarte, M.Sc · University of Navarra

• Irene I Cantero, M.Sc · University of Navarra

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2010-12-31

Completion

2011-11-30

Countries

• Spain

Study Locations