Metabolic SyndromeRESMENA-SNCT01087086
Reduction of the Metabolic Syndrome in Navarra-Spain
A study testing Crononutrition and American Heart Association in people with Metabolic Syndrome and Obesity, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Metabolic Syndrome, Obesity, Diabetes
- What is being tested?
- Crononutrition and American Heart Association
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Severe physical or mental disability
- Pregnancy
- Terminal disease
- Institutionalization
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Metabolic Syndrome, Obesity, Diabetes, Cardiovascular Disease
- Being tested
- Crononutrition, American Heart Association
- 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
- Medical subject headings
- Metabolic Syndrome, Obesity, Diabetes Mellitus, Cardiovascular Diseases, Insulin Resistance, Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrononutritionBehavioural
Also called RYTHMONUTRITION, METABOLIC SYNDROME, OBESITY, DIABETES
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 AssociationBehavioural
Also called RESMENA-A
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.
| Study group | Role | What they receive |
|---|---|---|
| Crononutrition | Experimental | 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 Receives: Behavioral: Crononutrition |
| American Heart Association | Placebo comparator | Dietary pattern:
* Personalized diet
* Caloric diet (-30% Total energy intake)
* Macronutrients distribution according to the American Heart Association (AHA) guidelines Receives: Behavioral: American Heart Association |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Lipid profile
To evaluate lipid improvements the following measurements will be taking into account:
- Free fatty acids
- Total cholesterol
- HDL-cholesterol
- LDL-cholesterol
Measured: One year
Glucose Profile
To evaluate glucose improvements the following measurements will be taking into account:
- Glucose
- Insulin
- HOMA
Measured: One year
Secondary outcomes (6)
Inflammation state
As secondary outcome some inflammatory markers will be analyzed:
- CRP
- IL-6
- TNF-alpha
- IL-18
- PAI-1
- Homocystein
Measured: One year
Oxidative stress
As secondary outcome some oxidative stress markers will be analyzed:
- MDA
- LDL-OX
- Total antioxidant capacity (TAC)
Measured: One year
Psychological tests
- Beck Depression Inventory
- Stai Trait Anxiety Inventory
- Mood thermometer visual analogue scale
- Anxiety thermometer visual analogue scale
- NEO personality inventory-revised test
Measured: January 2010-November 2011
Peripheral neurotransmitters
- Dopamine
- Dopac
- Serotonin
- 5-Hydroxyindoleacetic acid
- Noradrenaline
Measured: March-April 2013
Epigenetics
- DNA methylation
- microRNAs expression
Measured: April 2012-July 2014
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.
Measured: May 2016- January 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital of Navarra
- Responsible party
- Sponsor
- Investigators
- María Ángeles MA Zulet, PhD, Principal investigator, University of NavarraJosé Alfredo JA Martínez, PhD, RN, Study director, University of NavarraItziar I Abete, PhD, Study chair, University of NavarraLluis L Forga, PhD, Study chair, Hospital of NavarraBlanca Esther BE Martínez de Morentin, MD, Study chair, University of NavarraSantiago S Navas-Carretero, PhD, Study chair, University of NavarraRocío R de la Iglesia, M.Sc, Study chair, University of NavarraPatricia P López Legarrea, M.Sc, Study chair, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087086
- Sponsor's protocol ID
- RESMENA-S
- Acronym
- RESMENA-S
- Status last verified
- Nov 2011
- First submitted
- 11 Mar 2010
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hermsdorff HH, Zulet MA, Abete I, Martinez 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.
PubMed 19816812Puchau B, Zulet MA, de Echavarri AG, Hermsdorff HH, Martinez 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.
PubMed 19783122Perez-Matute P, Zulet MA, Martinez 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.
PubMed 19766058Toledo 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.
PubMed 19656442Sotos-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. Spanish.
PubMed 19457510Puchau B, Zulet MA, Gonzalez de Echavarri A, Navarro-Blasco I, Martinez 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.
PubMed 18985060Zulet MA, Puchau B, Navarro C, Marti A, Martinez JA. [Inflammatory biomarkers: the link between obesity and associated pathologies]. Nutr Hosp. 2007 Sep-Oct;22(5):511-27. Spanish.
PubMed 17970534Abete I, Parra MD, Zulet MA, Martinez 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.
PubMed 19079872Martinez MA, Puig JG, Mora M, Aragon R, O'Dogherty P, Anton JL, Sanchez-Villares T, Rubio JM, Rosado J, Torres R, Marcos J, Pallardo LF, Banegas JR; MAPA (Monitorizacion Ambulatoria de la Presion 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.
PubMed 18702949Sanchez-Chaparro MA, Calvo-Bonacho E, Gonzalez-Quintela A, Fernandez-Labandera C, Cabrera M, Sainz JC, Fernandez-Meseguer A, Banegas JR, Ruilope LM, Valdivielso P, Roman-Garcia 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.
PubMed 18753667Babio N, Bullo M, Basora J, Martinez-Gonzalez MA, Fernandez-Ballart J, Marquez-Sandoval F, Molina C, Salas-Salvado 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.
PubMed 19176282Abete 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.
PubMed 19298202Goyenechea E, Parra D, Crujeiras AB, Abete I, Martinez 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.
PubMed 19246894Abete 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.
PubMed 18308431Cantero I, Abete I, Del Bas JM, Caimari A, Arola L, Zulet MA, Martinez JA. Changes in lysophospholipids and liver status after weight loss: the RESMENA study. Nutr Metab (Lond). 2018 Jul 17;15:51. doi: 10.1186/s12986-018-0288-5. eCollection 2018.
PubMed 30026784
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01087086
- Acronym / sponsor ID
- RESMENA-S / RESMENA-S
- Conditions
- Metabolic Syndrome, Obesity, Diabetes, Cardiovascular Disease
- Keywords
- Metabolic syndrome, Oxidative stress, Proinflammatory state, Insulin resistance, Hypertension, Dyslipidemia, Mediterranean diet, Glycemic index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Hospital of Navarra
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 15 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crononutrition | Experimental | Behavioral: CrononutritionDietary 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 |
| American Heart Association | Placebo comparator | Behavioral: American Heart AssociationDietary pattern: * Personalized diet * Caloric diet (-30% Total energy intake) * Macronutrients distribution according to the American Heart Association (AHA) guidelines |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CrononutritionAlso: RYTHMONUTRITION, METABOLIC SYNDROME, OBESITY, DIABETESAfter 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. | Behavioural | Crononutrition |
| American Heart AssociationAlso: RESMENA-AAfter 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. | Behavioural | American Heart Association |
Primary outcome
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.
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
Glucose Profile
Time frame: One year
To evaluate glucose improvements the following measurements will be taking into account: * Glucose * Insulin * HOMA
6 secondary outcomes
Inflammation state
Time frame: One year
Oxidative stress
Time frame: One year
Psychological tests
Time frame: January 2010-November 2011
Peripheral neurotransmitters
Time frame: March-April 2013
Epigenetics
Time frame: April 2012-July 2014
Fatty Liver biomarkers / Non invasive liver scoring system.
Time frame: May 2016- January 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Background: PubMed 19816812Hermsdorff HH, Zulet MA, Abete I, Martinez 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.
- Background: PubMed 19783122Puchau B, Zulet MA, de Echavarri AG, Hermsdorff HH, Martinez 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.
- Background: PubMed 19766058Perez-Matute P, Zulet MA, Martinez 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.
- Background: PubMed 19656442Toledo 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.
- Background: PubMed 19457510Sotos-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. Spanish.
- Background: PubMed 18985060Puchau B, Zulet MA, Gonzalez de Echavarri A, Navarro-Blasco I, Martinez 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.
- Background: PubMed 17970534Zulet MA, Puchau B, Navarro C, Marti A, Martinez JA. [Inflammatory biomarkers: the link between obesity and associated pathologies]. Nutr Hosp. 2007 Sep-Oct;22(5):511-27. Spanish.
- Background: PubMed 19079872Abete I, Parra MD, Zulet MA, Martinez 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.
- Background: PubMed 18702949Martinez MA, Puig JG, Mora M, Aragon R, O'Dogherty P, Anton JL, Sanchez-Villares T, Rubio JM, Rosado J, Torres R, Marcos J, Pallardo LF, Banegas JR; MAPA (Monitorizacion Ambulatoria de la Presion 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.
- Background: PubMed 18753667Sanchez-Chaparro MA, Calvo-Bonacho E, Gonzalez-Quintela A, Fernandez-Labandera C, Cabrera M, Sainz JC, Fernandez-Meseguer A, Banegas JR, Ruilope LM, Valdivielso P, Roman-Garcia 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.
- Background: PubMed 19176282Babio N, Bullo M, Basora J, Martinez-Gonzalez MA, Fernandez-Ballart J, Marquez-Sandoval F, Molina C, Salas-Salvado 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.
- Background: PubMed 19298202Abete 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.
- European Master´s Degree in Feeding, Nutrition and MetabolismLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Ángeles MA Zulet, PhD principal investigator
University of Navarra
José Alfredo JA Martínez, PhD, RN study director
University of Navarra
Itziar I Abete, PhD study chair
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crononutrition and American Heart Association in people with Metabolic Syndrome and Obesity, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body fat (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01087086, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.