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Completed

NCT Number: NCT01087086

Reduction of the Metabolic Syndrome in Navarra-Spain

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

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

Treatment and study plan

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.

Other names: RYTHMONUTRITION, METABOLIC SYNDROME, OBESITY, DIABETES, CARDIOVASCULAR DISEASE, RESMENA-S

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.

Other names: RESMENA-A

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Collaborators

  • Hospital of Navarra

Registry information

Official study 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

Acronym: RESMENA-S

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Mar 15, 2010
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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