N/A
N=720
Effect of an Atlantic Diet on Anthropometric Indices and Serum Lipid Profile
Cardiovascular Disease · Adiposity · Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT02391701 ↗Enrolled (actual)
720
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Changes in Total-cholesterol Levels — -6.9; -0.6 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Diet (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 3+ yrs
- Sex
- All
- Sponsor
- Hospital Clinico Universitario de Santiago
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Total-cholesterol Levels |
-6.9; -0.6 | — |
| SECONDARY Change From Baseline in Body Weight |
-0.32; 0.62 | — |
| SECONDARY Change From Baseline in Body Mass Index (BMI) |
-0.29; 0.17 | — |
| SECONDARY Change From Baseline in Hip/Waist Index |
-0.015; -0.003 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose |
-1.9; -2.6 | — |
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.
Eligibility 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
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02391701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.