NCT02391701

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
5 years until next milestone

Results Posted

Study results publicly available

April 14, 2020

Completed
Last Updated

May 5, 2020

Status Verified

April 1, 2020

Enrollment Period

1.2 years

First QC Date

February 11, 2015

Results QC Date

April 2, 2020

Last Update Submit

April 24, 2020

Conditions

Cardiovascular DiseaseAdiposityHypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change From Baseline in Body Weight

    Baseline and 6 months

  • Change From Baseline in Body Mass Index (BMI)

    Baseline and 6 months

  • Change From Baseline in Hip/Waist Index

    Baseline and 6 months

  • Change From Baseline in Fasting Plasma Glucose

    Baseline and 6 months

Study Arms (2)

Diet group

EXPERIMENTAL

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.

Behavioral: Diet

Control

NO INTERVENTION

No intervention

Interventions

DietBEHAVIORAL

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)

Diet group

Eligibility Criteria

Age3 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • For the index subject:
  • Female or male.
  • years and older.
  • Living in a family unit with two or more people.
  • For the other family members:
  • Female or male.
  • Age between 3 to 85 years.

You may not qualify if:

  • For the index subject:
  • Alcoholism
  • Lipid treatment
  • Pregnant
  • Major cardiovascular disease
  • Dementia
  • Terminal disease
  • For the other family members:
  • Alcoholism
  • Pregnant
  • Major cardiovascular disease
  • Dementia
  • Terminal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico Universitario de Santiago

Santiago de Compostela, 15706, Spain

Location

Related Publications (2)

  • 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.

    PMID: 38324314DERIVED

  • 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.

    PMID: 27539113DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesObesityHypercholesterolemia

Interventions

Diet

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Results Point of Contact

Title
Dr. María del Mar Calvo Malvar
Organization
Hospital Clínico Universitario de Santiago
mariadelmar.calvo.malvar@sergas.es
34 981950395

Study Officials

  • Mar Calvo, PhD

    Servicio Galego de Saude (SERGAS)

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharmacy PhD, Specialist in Laboratory Medicine

Study Record Dates

First Submitted

February 11, 2015

First Posted

March 18, 2015

Study Start

March 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 5, 2020

Results First Posted

April 14, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)