Nutritional Study on the Beneficial Effects of Canned Fish Consumption on Healthy Adult Population

NCT05213273 | Completed

• 1 other identifier: SA-TUN-2021-01
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Diet

Keywords

canned fish; red blood cell membrane lipidomics; omega-3 fatty acids

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Biochemical parameters in plasma

  4 months

Other Outcomes (3)

• Nutrients intake (g/day)

  4 months

• Physical activity (MET-min per week)

  4 months

• Anthropometric parameters (weight and height)

  4 months

Study Arms (2)

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.

Behavioral: nutritional guidelines to promote healthy diet and increase fish intake

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.

Behavioral: nutritional guidelines to promote healthy diet and increase fish intake

Interventions

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.

Group A: Fresh/frozen fish; Group B: Canned fish

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults (men and women)
• \<BMI \<24.9.
• Individuals who habitually have a lower fish intake1-2 servings/week

You may not qualify if:

• Diagnosed with concomitant diseases or chronic disease.
• Have been subjected to transplant.
• Be taking medication
• Consuming or having consumed omega-3 supplements, vitamins, minerals, prebiotics or probiotics 3 months before starting the study. Food allergies.

Sponsors & Collaborators

• Sara Arranz Martinez: lead
• MUTUALIA S.L.: collaborator
• OSARTEN KOOPERATIBA ELKARTEA: collaborator

Study Sites (1)

AZTI

Derio, Bizkaia, 48160, Spain

Location

Related Links

• Sara Arranz ORCID
• AZTI web page

Study Officials

• Sara Arranz, PhD

  Fundacion Azti

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Researcher

Model Details: Randomized nutritional intervention clinical trial of 2 parallel groups, in which 150 healthy adults between 18 and 65 years will be recruited.

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: January 28, 2022
• Study Start: November 1, 2021
• Primary Completion: March 16, 2022
• Study Completion: July 30, 2022
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)