We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Reduction of the Metabolic Syndrome in Navarra-Spain (RESMENA-S)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01087086
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Metabolic Syndrome Obesity Diabetes Cardiovascular Disease Behavioral: Crononutrition Behavioral: American Heart Association

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reduction of the Metabolic Syndrome in Navarra-Spain (RESMENA-S) Through an Innovative Multidisciplinary Strategy Based on the Crononutrition and Dietary Training Concepts, in Addition to Both Dietary and Psychological Control
Study Start Date : January 2010
Primary Completion Date : December 2010
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Crononutrition

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
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.
Other Names:
  • RYTHMONUTRITION
  • METABOLIC SYNDROME
  • OBESITY
  • DIABETES
  • CARDIOVASCULAR DISEASE
  • RESMENA-S
Placebo Comparator: American Heart Association

Dietary pattern:

  • Personalized diet
  • Caloric diet (-30% Total energy intake)
  • Macronutrients distribution according to the American Heart Association (AHA) guidelines
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.
Other Name: RESMENA-A


Outcome Measures

Primary Outcome Measures :
  1. Body fat [ Time Frame: One year ]

    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.


  2. Lipid profile [ Time Frame: One year ]

    To evaluate lipid improvements the following measurements will be taking into account:

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

  3. Glucose Profile [ Time Frame: One year ]

    To evaluate glucose improvements the following measurements will be taking into account:

    • Glucose
    • Insulin
    • HOMA


Secondary Outcome Measures :
  1. Inflammation state [ Time Frame: One year ]

    As secondary outcome some inflammatory markers will be analyzed:

    • CRP
    • IL-6
    • TNF-alpha
    • IL-18
    • PAI-1
    • Homocystein

  2. Oxidative stress [ Time Frame: One year ]

    As secondary outcome some oxidative stress markers will be analyzed:

    • MDA
    • LDL-OX
    • Total antioxidant capacity (TAC)

  3. Psychological tests [ Time Frame: January 2010-November 2011 ]
    • Beck Depression Inventory
    • Stai Trait Anxiety Inventory
    • Mood thermometer visual analogue scale
    • Anxiety thermometer visual analogue scale
    • NEO personality inventory-revised test

  4. Peripheral neurotransmitters [ Time Frame: March-April 2013 ]
    • Dopamine
    • Dopac
    • Serotonin
    • 5-Hydroxyindoleacetic acid
    • Noradrenaline

  5. Epigenetics [ Time Frame: April 2012-July 2014 ]
    • DNA methylation
    • microRNAs expression

  6. Fatty Liver biomarkers / Non invasive liver scoring system. [ Time Frame: May 2016- January 2017 ]

    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.



Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 35-70 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:

  1. Fasting glucose ≥5.55 mmol/L or use of antidiabetic medication
  2. Systolic BP ≥130 mm Hg, diastolic BP ≥85 mm Hg, or use of antihypertensive medication
  3. 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

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087086


Locations
Spain
University of Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Hospital of Navarra
Investigators
Principal Investigator: María Ángeles MA Zulet, PhD University of Navarra
Study Director: José Alfredo JA Martínez, PhD, RN University of Navarra
Study Chair: 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
More Information

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01087086     History of Changes
Other Study ID Numbers: RESMENA-S
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: November 2011

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
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

Additional relevant MeSH terms:
Syndrome
Cardiovascular Diseases
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs