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

NCT ID: NCT02391701

Last Updated: 2020-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-05-31

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.

Conditions

Cardiovascular Disease; Adiposity; Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Diet

Intervention Type: BEHAVIORAL

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)

Control

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministerio de Economía y Competitividad, Spain

OTHER_GOV

Sponsor Role: collaborator

Hospital Clinico Universitario de Santiago

OTHER

Sponsor Role: lead

Responsible Party

Maria del Mar Calvo Malvar

Pharmacy PhD, Specialist in Laboratory Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mar Calvo, PhD

Role: STUDY_CHAIR

Servicio Galego de Saude (SERGAS)

Locations

Hospital Clinico Universitario de Santiago

Santiago de Compostela, , Spain

Countries

Spain

References

Cambeses-Franco C, Gude F, Benitez-Estevez AJ, Gonzalez-Garcia S, Leis R, Sanchez-Castro J, Moreira MT, Feijoo G, Calvo-Malvar M. Traditional Atlantic Diet and Its Effect on Health and the Environment: A Secondary Analysis of the GALIAT Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e2354473. doi: 10.1001/jamanetworkopen.2023.54473.

Reference Type: DERIVED

PMID: 38324314 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27539113 (View on PubMed)

Other Identifiers

HCSantiago

Identifier Type: -

Identifier Source: org_study_id