Reduction of the Metabolic Syndrome in Navarra-Spain

Obesity Clinical Trial

— RESMENA-S  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087086
• Other study ID #: RESMENA-S
• Status: Completed
• Phase: N/A
• First received: March 11, 2010
• Last updated: May 11, 2016
• Start date: January 2010
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: November 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	University of Navarra	Pamplona	Navarra

Sponsors (2)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	Hospital of Navarra

Country where clinical trial is conducted

Spain, 

References & Publications (14)

Abete I, Parra D, Martinez JA. Energy-restricted diets based on a distinct food selection affecting the glycemic index induce different weight loss and oxidative response. Clin Nutr. 2008 Aug;27(4):545-51. doi: 10.1016/j.clnu.2008.01.005. Epub 2008 Mar 4. — View Citation

Abete I, Parra D, Martinez JA. Legume-, fish-, or high-protein-based hypocaloric diets: effects on weight loss and mitochondrial oxidation in obese men. J Med Food. 2009 Feb;12(1):100-8. doi: 10.1089/jmf.2007.0700. — View Citation

Abete I, Parra MD, Zulet MA, Martínez JA. Different dietary strategies for weight loss in obesity: role of energy and macronutrient content. Nutr Res Rev. 2006 Jun;19(1):5-17. doi: 10.1079/NRR2006112. — View Citation

Babio N, Bulló M, Basora J, Martínez-González MA, Fernández-Ballart J, Márquez-Sandoval F, Molina C, Salas-Salvadó J; Nureta-PREDIMED Investigators. Adherence to the Mediterranean diet and risk of metabolic syndrome and its components. Nutr Metab Cardiovasc Dis. 2009 Oct;19(8):563-70. doi: 10.1016/j.numecd.2008.10.007. Epub 2009 Jan 26. — View Citation

Goyenechea E, Parra D, Crujeiras AB, Abete I, Martínez JA. A nutrigenomic inflammation-related PBMC-based approach to predict the weight-loss regain in obese subjects. Ann Nutr Metab. 2009;54(1):43-51. doi: 10.1159/000205319. Epub 2009 Feb 27. — View Citation

Hermsdorff HH, Zulet MÁ, Abete I, Martínez JA. Discriminated benefits of a Mediterranean dietary pattern within a hypocaloric diet program on plasma RBP4 concentrations and other inflammatory markers in obese subjects. Endocrine. 2009 Dec;36(3):445-51. doi: 10.1007/s12020-009-9248-1. — View Citation

Martínez MA, Puig JG, Mora M, Aragón R, O'Dogherty P, Antón JL, Sánchez-Villares T, Rubio JM, Rosado J, Torres R, Marcos J, Pallardo LF, Banegas JR; MAPA (Monitorización Ambulatoria de la Presión Arterial) Working Group. Metabolic syndrome: prevalence, associated factors, and C-reactive protein: the MADRIC (MADrid RIesgo Cardiovascular) Study. Metabolism. 2008 Sep;57(9):1232-40. doi: 10.1016/j.metabol.2008.04.017. — View Citation

Pérez-Matute P, Zulet MA, Martínez JA. Reactive species and diabetes: counteracting oxidative stress to improve health. Curr Opin Pharmacol. 2009 Dec;9(6):771-9. doi: 10.1016/j.coph.2009.08.005. Epub 2009 Sep 18. Review. — View Citation

Puchau B, Zulet MA, de Echávarri AG, Hermsdorff HH, Martínez JA. Dietary total antioxidant capacity is negatively associated with some metabolic syndrome features in healthy young adults. Nutrition. 2010 May;26(5):534-41. doi: 10.1016/j.nut.2009.06.017. Epub 2009 Sep 26. — View Citation

Puchau B, Zulet MA, González de Echávarri A, Navarro-Blasco I, Martínez JA. Selenium intake reduces serum C3, an early marker of metabolic syndrome manifestations, in healthy young adults. Eur J Clin Nutr. 2009 Jul;63(7):858-64. doi: 10.1038/ejcn.2008.48. Epub 2008 Nov 5. — View Citation

Sánchez-Chaparro MA, Calvo-Bonacho E, González-Quintela A, Fernández-Labandera C, Cabrera M, Sáinz JC, Fernández-Meseguer A, Banegas JR, Ruilope LM, Valdivielso P, Román-García J; Ibermutuamur Cardiovascular Risk Assessment (ICARIA) Study Group. Occupation-related differences in the prevalence of metabolic syndrome. Diabetes Care. 2008 Sep;31(9):1884-5. doi: 10.2337/dc08-0431. Epub 2008 Jun 20. — View Citation

Sotos-Prieto M, Zulet MA, Corella D. [Scientific evidence of the mediterranean diet effects in determining intermediate and final cardiovascular disease phenotypes]. Med Clin (Barc). 2010 Jan 23;134(1):22-9. doi: 10.1016/j.medcli.2009.01.033. Epub 2009 May 19. Review. Spanish. — View Citation

Toledo E, de A Carmona-Torre F, Alonso A, Puchau B, Zulet MA, Martinez JA, Martinez-Gonzalez MA. Hypothesis-oriented food patterns and incidence of hypertension: 6-year follow-up of the SUN (Seguimiento Universidad de Navarra) prospective cohort. Public Health Nutr. 2010 Mar;13(3):338-49. doi: 10.1017/S1368980009991066. Epub 2009 Aug 6. — View Citation

Zulet MA, Puchau B, Navarro C, Martí A, Martínez JA. [Inflammatory biomarkers: the link between obesity and associated pathologies]. Nutr Hosp. 2007 Sep-Oct;22(5):511-27. Review. Spanish. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body fat	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.	One year	Yes
Primary	Lipid profile	To evaluate lipid improvements the following measurements will be taking into account: Free fatty acids; Total cholesterol; HDL-cholesterol; LDL-cholesterol	One year	Yes
Primary	Glucose Profile	To evaluate glucose improvements the following measurements will be taking into account: Glucose; Insulin; HOMA	One year	Yes
Secondary	Inflammation state	As secondary outcome some inflammatory markers will be analyzed: CRP; IL-6; TNF-alpha; IL-18; PAI-1; Homocystein	One year	Yes
Secondary	Oxidative stress	As secondary outcome some oxidative stress markers will be analyzed: MDA; LDL-OX; Total antioxidant capacity (TAC)	One year	Yes
Secondary	Psychological tests	Beck Depression Inventory; Stai Trait Anxiety Inventory; Mood thermometer visual analogue scale; Anxiety thermometer visual analogue scale; NEO personality inventory-revised test	January 2010-November 2011	Yes
Secondary	Peripheral neurotransmitters	Dopamine; Dopac; Serotonin; 5-Hydroxyindoleacetic acid; Noradrenaline	March-April 2013	Yes
Secondary	Epigenetics	DNA methylation; microRNAs expression	April 2012-July 2014	Yes
Secondary	Fatty Liver biomarkers / Non invasive liver scoring system.	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.	May 2016- January 2017	Yes

External Links

•   Department of Nutrition, Food Science, Physiology and Toxicology
•   European Master´s Degree in Feeding, Nutrition and Metabolism