Reduction of the Metabolic Syndrome in Navarra-Spain (RESMENA-S)

University of Navarra

Status: Completed

Conditions: Diabetes; Obesity; Metabolic Syndrome; Cardiovascular Disease

Treatments: Behavioral: American Heart Association; Behavioral: Crononutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT01087086

RESMENA-S

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 2 patient groups, including a placebo group

Crononutrition

Experimental group

Description:

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

Treatment:

Behavioral: Crononutrition

American Heart Association

Placebo Comparator group

Description:

Dietary pattern: * Personalized diet * Caloric diet (-30% Total energy intake) * Macronutrients distribution according to the American Heart Association (AHA) guidelines

Treatment:

Behavioral: American Heart Association