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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02391701
Acronym
GALIAT
Enrollment
720
Registered
2015-03-18
Start date
2014-03-31
Completion date
2015-05-31
Last updated
2020-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adiposity, Cardiovascular Disease, Hypercholesterolemia

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

BEHAVIORALDiet

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

Ministerio de Economía y Competitividad, Spain
CollaboratorOTHER_GOV
Hospital Clinico Universitario de Santiago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 85 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Changes in Total-cholesterol Levelsbaseline and 6 monthsChange 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

MeasureTime frameDescription
Change From Baseline in Body WeightBaseline and 6 monthsMeasurements 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 monthsBMI 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 IndexBaseline and 6 monthsWaist 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 GlucoseBaseline and 6 monthsEnzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)

Countries

Spain

Participant flow

Participants by arm

ArmCount
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
Total720

Baseline characteristics

CharacteristicControlDiet GroupTotal
Age, Categorical
<=18 years
66 Participants80 Participants146 Participants
Age, Categorical
>=65 years
32 Participants49 Participants81 Participants
Age, Categorical
Between 18 and 65 years
255 Participants238 Participants493 Participants
Age, Continuous40.2 years
STANDARD_DEVIATION 20.8
38.6 years
STANDARD_DEVIATION 19.8
39.4 years
STANDARD_DEVIATION 20.3
Region of Enrollment
Spain
353 participants367 participants720 participants
Sex: Female, Male
Female
211 Participants214 Participants425 Participants
Sex: Female, Male
Male
142 Participants153 Participants295 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3670 / 353
other
Total, other adverse events
0 / 3670 / 353
serious
Total, serious adverse events
0 / 3670 / 353

Outcome results

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) \[Time Frame: 6 months \]

Time frame: baseline and 6 months

Population: Intent to treat population (all participants who were randomized)

ArmMeasureValue (MEAN)
Diet GroupChanges in Total-cholesterol Levels-6.9 mg/dl
ControlChanges in Total-cholesterol Levels-0.6 mg/dl
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.

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).

ArmMeasureValue (MEAN)
Diet GroupChange From Baseline in Body Mass Index (BMI)-0.29 Kg/m2
ControlChange From Baseline in Body Mass Index (BMI)0.17 Kg/m2
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.

Time frame: Baseline and 6 months

Population: Intent to treat population (all participants who were randomized)

ArmMeasureValue (MEAN)
Diet GroupChange From Baseline in Body Weight-0.32 Kg
ControlChange From Baseline in Body Weight0.62 Kg
Secondary

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)

ArmMeasureValue (MEAN)
Diet GroupChange From Baseline in Fasting Plasma Glucose-1.9 mg/dL
ControlChange From Baseline in Fasting Plasma Glucose-2.6 mg/dL
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.

Time frame: Baseline and 6 months

Population: Intent to treat population (all participants who were randomized)

ArmMeasureValue (MEAN)
Diet GroupChange From Baseline in Hip/Waist Index-0.015 Ratio
ControlChange From Baseline in Hip/Waist Index-0.003 Ratio

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026