Cardiovascular DiseaseGALIATNCT02391701
Effect of an Atlantic Diet on Anthropometric Indices and Serum Lipid Profile
A study testing Diet in people with Cardiovascular Disease and Adiposity, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 3 to 85 years
- Conditions the study is for
- Cardiovascular Disease, Adiposity, Hypercholesterolemia
- What is being tested?
- Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2014to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For the index subject:
- Female or male.
- 18 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.
Who cannot join
- For the index subject:
- Alcoholism
- Lipid treatment
- Pregnant
- Major cardiovascular disease
- Dementia
Show all 13Show fewer
- Terminal disease
- For the other family members:
- Alcoholism
- Pregnant
- Major cardiovascular disease
- Dementia
- Terminal disease
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clinico Universitario de Santiago
Santiago de Compostela, 15706
About this study
Official title: Effect of an Atlantic Diet on Anthropometric Indices and Serum Lipid Profile in a General Population: a Randomised Controlled Trial
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.
Read more
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.
Read the 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
- Being tested
- Diet
- Medical subject headings
- Cardiovascular Diseases, Obesity, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Diet |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ]
Measured: baseline and 6 months
Secondary outcomes (4)
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.
Measured: Baseline and 6 months
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.
Measured: Baseline and 6 months
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.
Measured: Baseline and 6 months
Change From Baseline in Fasting Plasma Glucose
Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startMar 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Universitario de Santiago
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Principal investigator, Maria del Mar Calvo Malvar, Hospital Clinico Universitario de Santiago
- Investigators
- Mar Calvo, PhD, Study chair, Servicio Galego de Saude (SERGAS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391701
- Sponsor's protocol ID
- HCSantiago
- Acronym
- GALIAT
- Status last verified
- Apr 2020
- First submitted
- 11 Feb 2015
- Last updated
- 5 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 38324314Calvo-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.
PubMed 27539113
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Atlantic Diet on Anthropometric Indices and Serum Lipid Profile in a General Population: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02391701
- Acronym / sponsor ID
- GALIAT / HCSantiago
- Conditions
- Cardiovascular Disease, Adiposity, Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Hospital Clinico Universitario de SantiagoUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- Mar 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Posted 14 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet group | Experimental | Behavioral: DietDiet 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. |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 3 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- For the index subject:
- For the other family members:
Key exclusion criteria (13 listed)
- For the index subject:
- For the other family members:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietdiet 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) | Behavioural | Diet group |
Primary outcome
Changes in Total-cholesterol Levels
Time frame: baseline and 6 months
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 ]
4 secondary outcomes
Change From Baseline in Body Weight
Time frame: Baseline and 6 months
Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline and 6 months
Change From Baseline in Hip/Waist Index
Time frame: Baseline and 6 months
Change From Baseline in Fasting Plasma Glucose
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38324314Cambeses-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.
- Derived from this study: PubMed 27539113Calvo-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mar Calvo, PhD study chair
Servicio Galego de Saude (SERGAS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Cardiovascular Disease and Adiposity, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Total-cholesterol Levels (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02391701, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.