Reduction of the Metabolic Syndrome in Navarra-Spain
מילות מפתח
תַקצִיר
תיאור
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.
תאריכים
| אומת לאחרונה: | 10/31/2011 |
| הוגש לראשונה: | 03/10/2010 |
| ההרשמה המשוערת הוגשה: | 03/11/2010 |
| פורסם לראשונה: | 03/14/2010 |
| העדכון האחרון הוגש: | 05/10/2016 |
| עדכון אחרון פורסם: | 05/11/2016 |
| תאריך תחילת לימוד בפועל: | 12/31/2009 |
| תאריך סיום משוער משוער: | 11/30/2010 |
| תאריך סיום משוער ללימודים: | 10/31/2011 |
מצב או מחלה
התערבות / טיפול
Behavioral: Crononutrition
Behavioral: American Heart Association
שלב
קבוצות זרועות
| זְרוֹעַ | התערבות / טיפול |
|---|---|
| Experimental: Crononutrition 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 | 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. |
| Placebo Comparator: American Heart Association Dietary pattern:
Personalized diet
Caloric diet (-30% Total energy intake)
Macronutrients distribution according to the American Heart Association (AHA) guidelines | Behavioral: 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. |
קריטריונים לזכאות
| גילאים הזכאים ללימודים | 35 Years ל 35 Years |
| מינים הזכאים ללימודים | All |
| מקבל מתנדבים בריאים | כן |
| קריטריונים | 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 |
תוֹצָאָה
מדדי תוצאות ראשוניים
1. Body fat [One year]
2. Lipid profile [One year]
3. Glucose Profile [One year]
אמצעי תוצאה משניים
1. Inflammation state [One year]
2. Oxidative stress [One year]
3. Psychological tests [January 2010-November 2011]
4. Peripheral neurotransmitters [March-April 2013]
5. Epigenetics [April 2012-July 2014]
6. Fatty Liver biomarkers / Non invasive liver scoring system. [May 2016- January 2017]
