Effect of an Atlantic Diet on Anthropometric Indices and Serum Lipid Profile
NCT02391701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 720
Last updated 2020-05-05
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.
Conditions
- Cardiovascular Disease
- Adiposity
- Hypercholesterolemia
Interventions
- BEHAVIORAL
-
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)
Sponsors & Collaborators
-
Ministerio de Economía y Competitividad, Spain
collaborator OTHER_GOV -
Hospital Clinico Universitario de Santiago
lead OTHER
Principal Investigators
-
Mar Calvo, PhD · Servicio Galego de Saude (SERGAS)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 3 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-03-31
- Primary Completion
- 2015-05-31
- Completion
- 2015-05-31
Countries
- Spain
Study Locations
More Related Trials
-
Sustainable Diets and Cardiometabolic Health
NCT07189676 ·Status: RECRUITING ·Phase: NA
-
The Effect of Fatty Acid Composition on Energy Intake and Satiety
NCT00242021 ·Status: COMPLETED ·Phase: NA
-
Unsaturated Fatty Acids Enriched-diet to Improve Cardiorespiratory Fitness, Metabolic Flexibility and Glucose Tolerance in Obese Patients
NCT03310099 ·Status: COMPLETED ·Phase: NA
-
Diets With a Spectrum of Fat Intake for Preventing Obesity: A Randomized Controlled-feeding Trial
NCT02355795 ·Status: COMPLETED ·Phase: NA
-
Trial of Different Dietary Fats on Blood Lipids and Metabolic Measures in Healthy Participants
NCT03105947 ·Status: COMPLETED ·Phase: NA
-
Brazilian Cardioprotective Nutritional Program Trial
NCT01620398 ·Status: COMPLETED ·Phase: NA
-
Mediterranean Diet and Endothelial Function
NCT01797211 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of a Vegan Diet Versus a Mediterranean Diet. Assessing Health Outcomes
NCT06008886 ·Status: COMPLETED ·Phase: NA
-
Dietary Treatment of Hyperlipidemia in Women vs. Men
NCT00005336 ·Status: COMPLETED
-
Does the Advice to Eat a Mediterranean Diet With Low Carbohydrate Intake, Compared With a Low-fat Diet, Reduce Diabetes and Cardiovascular Disease?
NCT02938832 ·Status: UNKNOWN ·Phase: PHASE4
-
The Effect of Medium-chain Fatty Acids on Cardiac Function
NCT06399354 ·Status: COMPLETED ·Phase: NA
-
Cardiovascular Risk Prevention With a Mediterranean Dietary Pattern Reduced in Saturated Fat
NCT05778656 ·Status: COMPLETED ·Phase: NA
-
Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women (ALIMED)-Part 2
NCT01852721 ·Status: COMPLETED ·Phase: NA
-
Modulation of Cardiovascular Risk Factors by the Diet
NCT02637778 ·Status: COMPLETED ·Phase: NA
-
Saturated Fatty Acids and HDL Metabolism
NCT02835651 ·Status: COMPLETED ·Phase: NA
-
Impact of MEditerranean Diet, Inflammation and Microbiome After an Acute Coronary Syndrome
NCT03842319 ·Status: COMPLETED ·Phase: NA
-
CVD Nutrition Education
NCT00005727 ·Status: COMPLETED ·Phase: NA
-
The Acute Effects of Meals Rich in Saturated or Unsaturated Fatty Acids on Postprandial Lipaemia in Healthy Men
NCT05264233 ·Status: COMPLETED ·Phase: NA
-
Platform for Clinical Trials in Nutrition and Health
NCT04067921 ·Status: ACTIVE_NOT_RECRUITING
-
Dietary Effects on Lipoproteins and Thrombogenic Activity
NCT00000538 ·Status: COMPLETED ·Phase: PHASE3
-
Breakfast Test Products and Acute Satiety Scores
NCT02575131 ·Status: COMPLETED ·Phase: PHASE2
-
Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women
NCT01293344 ·Status: COMPLETED ·Phase: NA
-
Effects of Canola Oil and Coconut Oil on Postprandial Metabolism in Older Adults With Increased Cardiometabolic Risk
NCT05208346 ·Status: COMPLETED ·Phase: NA
-
The Effect of Palm Olein, Olive Oil and Lard and on Risk Markers of Cardiovascular Disease
NCT00743301 ·Status: UNKNOWN ·Phase: NA
-
Replacement of Saturated Fat in Dairy on Total Cholesterol
NCT02089035 ·Status: COMPLETED ·Phase: NA