Clinical trial NCT02391701: Effect of an Atlantic Diet on Anthropometric Indices and Serum Lipid Profile
Official title: Effect of an Atlantic Diet on Anthropometric Indices and Serum Lipid Profile in a General Population: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Adiposity
Hypercholesterolemia
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2015-03-18
Enrollment: 720
Sex: ALL
Minimum age (years): 3
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Changes in Total-cholesterol Levels
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Change From Baseline in Body Weight
timeFrame: Baseline and 6 months
measure: Change From Baseline in Body Mass Index (BMI)
timeFrame: Baseline and 6 months
measure: Change From Baseline in Hip/Waist Index
timeFrame: Baseline and 6 months
measure: Change From Baseline in Fasting Plasma Glucose
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
Study officials:
affiliation: Servicio Galego de Saude (SERGAS)
name: Mar Calvo, PhD
role: STUDY_CHAIR
References:
citation: Calvo-Malvar Mdel M, Leis R, Benitez-Estevez AJ, Sanchez-Castro J, Gude F. A randomised, family-focused dietary intervention to evaluate the Atlantic diet: the GALIAT study protocol. BMC Public Health. 2016 Aug 18;16(1):820. doi: 10.1186/s12889-016-3441-y.