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

Healthy Diet Clinical Trial

— TUNACAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05213273
• Other study ID #: SA-TUN-2021-01
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: November 2023
• Source: Fundacion Azti
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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:

• Assessment of the health benefits of consuming canned fish (controlled intake): impact on the fatty acid profile of red blood cell membrane.

• Provide evidence of the benefits of consuming canned fish compared to intake fresh / frozen fish.

• Demystify the bad reputation of canned fish products (as processed foods).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: July 30, 2022
• Est. primary completion date: March 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy adults (men and women)

• 18.5 <BMI <24.9.

• Individuals who habitually have a lower fish intake1-2 servings/week

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Healthy Diet

Intervention

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

Locations

Country	Name	City	State
Spain	AZTI	Derio	Bizkaia

Sponsors (3)

Lead Sponsor	Collaborator
Sara Arranz Martinez	MUTUALIA S.L., OSARTEN KOOPERATIBA ELKARTEA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	4 months
Other	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
Other	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
Primary	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	Biochemical parameters in plasma	Blood cholesterol (mg/dL): total cholesterol, HDL-c and LDL-c Triglycerides (mg/dL) Glucose (mg/dL)	4 months

External Links

•   AZTI web page
•   Sara Arranz ORCID