Effect of an Atlantic Diet on Anthropometric Indices and Serum Lipid Profile

Cardiovascular Disease Clinical Trial

— GALIAT  

Official title:

Effect of an Atlantic Diet on Anthropometric Indices and Serum Lipid Profile in a General Population: a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391701
• Other study ID #: HCSantiago
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: May 2015

Study information

• Verified date: April 2020
• Source: Hospital Clinico Universitario de Santiago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adiposity
• Cardiovascular Disease
• Cardiovascular Diseases
• Hypercholesterolemia

Intervention

Behavioral:
• 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)

Locations

Country	Name	City	State
Spain	Hospital Clinico Universitario de Santiago	Santiago de Compostela

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinico Universitario de Santiago	Centre for the Development of Industrial Technology (CDTI)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ]	baseline and 6 months
Secondary	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.	Baseline and 6 months
Secondary	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.	Baseline and 6 months
Secondary	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.	Baseline and 6 months
Secondary	Change From Baseline in Fasting Plasma Glucose	Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)	Baseline and 6 months