University of Navarra
Pamplona, Navarre, 31008, Spain
NCT Number: NCT01087086
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.
Looking for future studies?
Notify Me35 year–70 year
All sexes
Interventional
Not applicable
Pamplona, Navarre, 31008, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Waist circumference cutoffs (male ≥94 cm or female ≥80 cm) plus any two of the following four factors:
Exclusion criteria
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
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
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.
Time frame: One year
To evaluate lipid improvements the following measurements will be taking into account:
Time frame: One year
To evaluate glucose improvements the following measurements will be taking into account:
Time frame: One year
As secondary outcome some inflammatory markers will be analyzed:
Time frame: One year
As secondary outcome some oxidative stress markers will be analyzed:
Time frame: January 2010-November 2011
Time frame: March-April 2013
Time frame: April 2012-July 2014
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.
Clinica Universidad de Navarra, Universidad de Navarra
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT01630980
Body Weight, Cardiovascular Diseases
Toronto, Ontario, Canada
View Trial DetailsNCT02037321
Arthritis, Body Weight
Toronto, Ontario, Canada
View Trial DetailsNCT04392284
Body Weight, Cardiovascular Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT03191227
Behavior, Behavior, Animal
View Trial Details