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Reduction of the Metabolic Syndrome in Navarra-Spain

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01087086
Acronym
RESMENA-S
Enrollment
109
Registered
2010-03-15
Start date
2010-01-31
Completion date
2011-11-30
Last updated
2016-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Diabetes, Metabolic Syndrome, Obesity

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

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.

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.

Interventions

BEHAVIORALCrononutrition

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.

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

Hospital of Navarra
CollaboratorOTHER
Clinica Universidad de Navarra, Universidad de Navarra
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Body fatOne yearThrough 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 profileOne yearTo evaluate lipid improvements the following measurements will be taking into account: * Free fatty acids * Total cholesterol * HDL-cholesterol * LDL-cholesterol
Glucose ProfileOne yearTo evaluate glucose improvements the following measurements will be taking into account: * Glucose * Insulin * HOMA

Secondary

MeasureTime frameDescription
Peripheral neurotransmittersMarch-April 2013* Dopamine * Dopac * Serotonin * 5-Hydroxyindoleacetic acid * Noradrenaline
Inflammation stateOne yearAs secondary outcome some inflammatory markers will be analyzed: * CRP * IL-6 * TNF-alpha * IL-18 * PAI-1 * Homocystein
Fatty Liver biomarkers / Non invasive liver scoring system.May 2016- January 2017Measurements 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.
EpigeneticsApril 2012-July 2014* DNA methylation * microRNAs expression
Oxidative stressOne yearAs secondary outcome some oxidative stress markers will be analyzed: * MDA * LDL-OX * Total antioxidant capacity (TAC)
Psychological testsJanuary 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026