Adiposity, Cardiovascular Disease, Hypercholesterolemia
Conditions
Brief summary
BACKGROUND: The Southern European Atlantic Diet (SEAD) is the traditional diet of Northern Portugal and Galicia, a region in northwest Spain. The SEAD has been associated with a lower risk of non-fatal acute myocardial infarction. Possible mechanisms of this association may be related with a lower concentration of markers of inflammation and with reduced triglycerides, insulin, insulin resistance, and systolic blood pressure. Aim: To evaluate the effect of an Atlantic Diet on i) lipid profile, ii) markers of inflammation, and iii) anthropometric indices in a population-based study METHODS: This is a non-pharmacological clinical trial study which is performed on a family-oriented basis. 250 families (\ 750 children and adults, older than 3 years) were selected to participate in the study and randomized into Atlantic Diet (AD) (n=125 families) and control (n=125 families) groups. The AD groups participate in a diet program 1 day a month for 3 months in 120-minute diet sessions and freely receive AD food, characterized by a high intake of vegetables, cheese, olive oil, mussels and by wine consumption during meals. Control group subjects do not participate in any regular diet activity during this period and did not receive additional food. Exclusion criteria are alcoholism, lipid treatment, dementia, and terminal disease. Weight, BMI, waist circumference (WC), skin folds, nutrient intake from 3-day recalls, food frequency questionnaire, physical activity, blood pressure, metabolic function (fasting blood glucose, HBA1c, insulin resistance and lipid profile), and inflammation markers (c-reactive protein, interleukin 6 and tumor necrosis factor-alpha) are measured at baseline, 3 and 6 months. Mixed effect models will be performed to assess the significance of changes in the cardiometabolic parameters. The primary end point is the change in lipid profile compared with baseline and the control group arm at the end of Month 6. The secondary exploratory end points were change in anthropometric indices and inflammation markers at Month 6.
Detailed description
The intervention period lasted 6 months. At the baseline visit all AD subjects received information on the Atlantic diet and how to follow it; the nutritionists' messages were adapted to the clinical condition of each subject, his/her preferences, needs, beliefs and culture. Special care was taken with patients who were obese, had diabetes or who had high blood cholesterol; conflicts with recommendations made by subjects' own doctors or nutritionists were avoided. All questionnaires (see below) were filled out in the presence of the nutritionists, except for 3-day food records which the subjects handed in completed. The latter were reviewed in the presence of the subjects in order to correct any errors or add missing information. At the 3 and 6 month visits, the nutritionists reminded the subjects about the Atlantic diet and the helped them complete their questionnaires. Foods were provided to the families of the AD group. Wine was provided only to non-tee-total adults. Food packages were delivered every three weeks to the family home. The food included in the package was calculated for the total number of family members, even if not all were taking part in the study. At delivery, a form was filled in to verify that the previous lot of food had been consumed, and to note any problems.
Interventions
diet program 1 day a month for 3 months in 120-minute diet sessions + freely receive Atlantic Diet food (vegetables, cheese, olive oil, mussels and wine)
Sponsors
Study design
Eligibility
Inclusion criteria
A random sample of the population 18 years and older was drawn from the National Health System Register in order to select the index subjects.These individuals (index subjects) and all family members sharing the same house were invited to participate in the study. Inclusion Criteria: 1. For the index subject: * Female or male. * 18 years and older. * Living in a family unit with two or more people. 2. For the other family members: * Female or male. * Age between 3 to 85 years.
Exclusion criteria
1. For the index subject: * Alcoholism * Lipid treatment * Pregnant * Major cardiovascular disease * Dementia * Terminal disease 2. For the other family members: * Alcoholism * Pregnant * Major cardiovascular disease * Dementia * Terminal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Total-cholesterol Levels | baseline and 6 months | Change from baseline in total cholesterol: Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics) \[Time Frame: 6 months \] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Body Weight | Baseline and 6 months | Measurements will be made in triplicate and recorded by standard methods using a SECA 813 digital balance with the subjects in underwear and barefoot. Body weight will be measured to the nearest 0.1 kg. |
| Change From Baseline in Body Mass Index (BMI) | Baseline and 6 months | BMI will be calculated as body weight (kg) divided by height (m) squared. The BMI of subjects under 18 years of age will be standardised using World Health Organization (WHO) reference data. |
| Change From Baseline in Hip/Waist Index | Baseline and 6 months | Waist circumference will be measured at the narrowest point between the bottom rib and the top of the iliac crest using a SECA 201 flexible, non-elastic tape. Hip circumference will be measured at the point of greatest prominence of the gluteal muscles using a SECA 201 flexible, non-elastic tape. |
| Change From Baseline in Fasting Plasma Glucose | Baseline and 6 months | Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics) |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diet Group Diet program 1 day a month for 3 months in 120-minute diet sessions + Freely they receive AD food: vegetables, cheese, olive oil, mussels and wine.
Diet: diet program 1 day a month for 3 months in 120-minute diet sessions + freely receive Atlantic Diet food (vegetables, cheese, olive oil, mussels and wine) | 367 |
| Control No intervention | 353 |
| Total | 720 |
Baseline characteristics
| Characteristic | Control | Diet Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 66 Participants | 80 Participants | 146 Participants |
| Age, Categorical >=65 years | 32 Participants | 49 Participants | 81 Participants |
| Age, Categorical Between 18 and 65 years | 255 Participants | 238 Participants | 493 Participants |
| Age, Continuous | 40.2 years STANDARD_DEVIATION 20.8 | 38.6 years STANDARD_DEVIATION 19.8 | 39.4 years STANDARD_DEVIATION 20.3 |
| Region of Enrollment Spain | 353 participants | 367 participants | 720 participants |
| Sex: Female, Male Female | 211 Participants | 214 Participants | 425 Participants |
| Sex: Female, Male Male | 142 Participants | 153 Participants | 295 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 367 | 0 / 353 |
| other Total, other adverse events | 0 / 367 | 0 / 353 |
| serious Total, serious adverse events | 0 / 367 | 0 / 353 |
Outcome results
Changes in Total-cholesterol Levels
Change from baseline in total cholesterol: Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics) \[Time Frame: 6 months \]
Time frame: baseline and 6 months
Population: Intent to treat population (all participants who were randomized)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet Group | Changes in Total-cholesterol Levels | -6.9 mg/dl |
| Control | Changes in Total-cholesterol Levels | -0.6 mg/dl |
Change From Baseline in Body Mass Index (BMI)
BMI will be calculated as body weight (kg) divided by height (m) squared. The BMI of subjects under 18 years of age will be standardised using World Health Organization (WHO) reference data.
Time frame: Baseline and 6 months
Population: Intent to treat population (all adult participants who were randomized). The BMI of subjects under 18 years of age were not included (80 participants in the Diet Group and 66 participants in the Control Group).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet Group | Change From Baseline in Body Mass Index (BMI) | -0.29 Kg/m2 |
| Control | Change From Baseline in Body Mass Index (BMI) | 0.17 Kg/m2 |
Change From Baseline in Body Weight
Measurements will be made in triplicate and recorded by standard methods using a SECA 813 digital balance with the subjects in underwear and barefoot. Body weight will be measured to the nearest 0.1 kg.
Time frame: Baseline and 6 months
Population: Intent to treat population (all participants who were randomized)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet Group | Change From Baseline in Body Weight | -0.32 Kg |
| Control | Change From Baseline in Body Weight | 0.62 Kg |
Change From Baseline in Fasting Plasma Glucose
Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)
Time frame: Baseline and 6 months
Population: Intent to treat population (all participants who were randomized)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet Group | Change From Baseline in Fasting Plasma Glucose | -1.9 mg/dL |
| Control | Change From Baseline in Fasting Plasma Glucose | -2.6 mg/dL |
Change From Baseline in Hip/Waist Index
Waist circumference will be measured at the narrowest point between the bottom rib and the top of the iliac crest using a SECA 201 flexible, non-elastic tape. Hip circumference will be measured at the point of greatest prominence of the gluteal muscles using a SECA 201 flexible, non-elastic tape.
Time frame: Baseline and 6 months
Population: Intent to treat population (all participants who were randomized)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet Group | Change From Baseline in Hip/Waist Index | -0.015 Ratio |
| Control | Change From Baseline in Hip/Waist Index | -0.003 Ratio |