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| Name | Class |
|---|---|
| MUTUALIA S.L. | UNKNOWN |
| OSARTEN KOOPERATIBA ELKARTEA | UNKNOWN |
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There is sufficient evidence on the beneficial effects of fish consumption on health, mainly associated with the content of omega-3 polyunsaturated fatty acids (EPA and DHA) present mainly in blue fish. Different national and international organizations have issued recommendations on the optimal amount of fish that the population should consume to prevent certain chronic diseases related to diet. Thus, the WHO recommends eating fish regularly (1-2 servings per week for healthy adults) to ideally provide the equivalent of 250 mg of omega-3 fatty acids (EPA + DHA). Not reaching the optimal levels of EPA + DHA increases the risk for cardiovascular diseases, increasing the risk of death according to certain epidemiological studies. In this sense, using more precise techniques such as membrane lipidomics, allow adequate quantification and monitoring of fatty acid levels present in our body and how this lipid profile can change according to metabolism and diet. The objective of this study is to carry out a clinical trial of nutritional intervention with an adult population without pathologies that has a low consumption of fish (<2 servings / week) to evaluate the effectiveness of an intervention strategy based on increasing the number of fish servings through a controlled intake of fresh and canned fish.
The results aim to show that increasing fish intake has an impact on lipid metabolism and in the future, for the prevention of certain chronic diseases, the introduction of canned fish can be a healthy strategy to increase fish consumption to long term.
Objectives:
The main objective of this study is to demonstrate through a nutritional intervention, the benefits of the intake of canned fish compared to fresh or frozen fish on lipid metabolism in a healthy adult population, which can be divided into three specific objectives:
Study design:
A prospective, randomized, controlled, parallel-group nutritional intervention clinical trial will be carried out with 150 healthy adults between 18 and 65 years for 4 months. Participants will be randomized into one of the two equal size intervention groups: "group A: fresh/frozed fish" or "group B: canned fish".
Recruitment and selection of participants:
AZTI will organize the selection and recruitment process in collaboration with IMQ-Prevention (MUTUALIA) through 4 centers in Spain (Zamudio, Bilbao, Vitoria and Donosti) and with the OSARTEN Koop clinical analysis laboratory.
Participants will be distributed according to a random assignment sequence. In this way, investigators increase the probability that the two groups (control and intervention) are comparable with respect to age and gender.
Inclusion criteria: Healthy adults (men and women) with 18.5 \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Fresh/frozen fish | Experimental | Healthy diet based on mediterranean guidelines with specific recommendation of fish intake (3-4 servings/week of fresh or frozen fish or shellfish), excluding the consumption of canned fish. |
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| Group B: Canned fish | Experimental | Healthy diet based on mediterranean guidelines with specific recommendation of fish intake (3-4 servings/week of fresh or frozen fish or shellfish where at least 1-2 servings will be in the form of canned fish). A selection of canned fish (tuna, sardine, salmon and mackerel) will be administered to each volunteer for the duration of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutritional guidelines to promote healthy diet and increase fish intake | Behavioral | Nutritional guidelines based on the Mediterranean diet will be provided to both groups (gropu A and group B) through infographic material, recipes and menus. Both groups will be guided to increase their fish consumption to 3 servings per week. Group A will do that through the consumption of fresh or frozen fish and group B through fresh, frozen and canned fish. |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic status: RBC membrane fatty acid profile. | Twelve fatty acids will by analyzed as representative cluster of the main building blocks of the red blood cell (RBC) membrane glycerophospholipids (palmitic acid, stearic acid, palmitoleic acid, oleic acid, cis-vaccenic acid, eicosapentaenoic acid, docosahexaenoic acid, linoleic acid, dihomo-gamma-linolenic acid (DGLA), arachidonic acid (AA) and two geometrical trans fatty acids (trans elaidic acid and mono-trans arachidonic acid isomer). The amount of each fatty acid will be calculated as a percentage of the total fatty acid content in the red blood cell membrane (relative %). Omega 3 index (EPA+DHA) as a biomarker of cardiovascular risk and omega-6/omega-3 ratio as biomarker of inflammatory status will be the main outcomes. Investigators will take into accounts the optimal ranges of each of the 12 fatty acids in red blood cell membranes previously reported in the literature (Ferreri C et al. 2012. Expert Rev. Mol. Diagn. 12(7), 767-780). | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical parameters in plasma | Blood cholesterol (mg/dL): total cholesterol, HDL-c and LDL-c Triglycerides (mg/dL) Glucose (mg/dL) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Nutrients intake (g/day) | Participants in the study will complete a food frequency questionnaire based on the PREDIMED validated questionnaire for the Spanish population (Fernández-Ballart et al, 2010). These questionnaire will be completed at the beginning and after 4 months of intervention to measure change in dietary intake (food groups and nutrients). Information about different food items collected from this questionnaire will be analyzed using DIAL® software to translate their intake into their corresponding energy (kilocalories) and nutrient intake (g/day). |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Arranz, PhD | Fundacion Azti | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZTI | Derio | Bizkaia | 48160 | Spain |
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| Label | URL |
|---|---|
| Sara Arranz ORCID | View source |
| AZTI web page | View source |
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Randomized nutritional intervention clinical trial of 2 parallel groups, in which 150 healthy adults between 18 and 65 years will be recruited.
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| 4 months |
| Physical activity (MET-min per week) | Participants in the study will complete the international physical activity questionnaire (IPAQ). IPAQ will be scored using the continuous variable MET minutes a week that represent the amount of energy expended carrying out physical activity. Participants will complete this IPAQ at the beginning and after 4 months of intervention to compare physical activity. | 4 months |
| Anthropometric parameters (weight and height) | Weight (kg) and height (m) will be combined to report body mass index (BMI) in kg/m^2 | 4 months |