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

This study has been completed.
Sponsor:
Collaborator:
Hospital of Navarra
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01087086
First received: March 11, 2010
Last updated: March 20, 2014
Last verified: November 2011
  Purpose

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 Intervention
Metabolic Syndrome
Obesity
Diabetes
Cardiovascular Disease
Behavioral: Crononutrition
Behavioral: American Heart Association

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • Body fat [ Time Frame: One year ] [ Designated as safety issue: Yes ]

    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.


  • Lipid profile [ Time Frame: One year ] [ Designated as safety issue: Yes ]

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

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

  • Glucose Profile [ Time Frame: One year ] [ Designated as safety issue: Yes ]

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

    • Glucose
    • Insulin
    • HOMA


Secondary Outcome Measures:
  • Inflammation state [ Time Frame: One year ] [ Designated as safety issue: Yes ]

    As secondary outcome some inflammatory markers will be analyzed:

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

  • Oxidative stress [ Time Frame: One year ] [ Designated as safety issue: Yes ]

    As secondary outcome some oxidative stress markers will be analyzed:

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

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

  • Peripheral neurotransmitters [ Time Frame: March-April 2013 ] [ Designated as safety issue: Yes ]
    • Dopamine
    • Dopac
    • Serotonin
    • 5-Hydroxyindoleacetic acid
    • Noradrenaline


Enrollment: 109
Study Start Date: January 2010
Study Completion Date: November 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • CRONONUTRITION
  • 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

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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:

Additional 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
Study First Received: March 11, 2010
Last Updated: March 20, 2014
Health Authority: Spain: Ethics Committee
Spain: Ministry of Health

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:
Cardiovascular Diseases
Obesity
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014