Healthy DietTUNACANNCT05213273
Nutritional Study on the Beneficial Effects of Canned Fish Consumption on Healthy Adult Population
A study testing nutritional guidelines to promote healthy diet and increase fish intake in people with Healthy Diet, run by Sara Arranz Martinez at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet
- What is being tested?
- nutritional guidelines to promote healthy diet and increase fish intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2021to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults (men and women)
- 18.5 <BMI <24.9.
- Individuals who habitually have a lower fish intake1-2 servings/week
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TUNACAN: Nutritional Study on the Beneficial Effects of Canned Fish Consumption on Healthy Adult Population
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.
Read the detailed 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 <BMI < 27 kg/m2. Those individuals who usually have a fish intake of less than 1-2 servings per week will be included.
Exclusion criteria: Having been diagnosed with concomitant diseases or chronic disease that can modify the results. Having undergone a transplant. Be taking medication and consuming or have consumed omega 3 supplements, vitamins, prebiotics.. in the last 4 months before starting the study. Allergy to fish or any food.
Sample size calculation:
The sample size was calculated with the G * power software based on the defined primary objective of observing differences in the lipid profile of the red blood cell membrane obtained after the ANCOVA test for fixed effects and interactions. A priori investigators expect a mean effect (f = 0.25) for a statistical power of 80.0% (1-β = 0.80) and taking into account that the significance level is 5.0%, it will be necessary to include 64 experimental units in the control group and 64 units in the experimental group that sum 128 experimental units in the study. Taking into account that the expected dropout percentage is around 20.0%, a total of 150 experimental units would be necessary in the study.
Primary outcome:
- Metabolic status will be evaluated measuring 12 fatty acids in 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 this fatty acids in red blood cell membranes previously reported in the litearature (Ferreri C et al. 2012. Expert Rev. Mol. Diagn. 12(7), 767-780). Secondary outcomes:
- Biochemical parameters: total cholesterol (mg/dL), HDL cholesterol (mg/dL), LDL cholesterol (mg/dL), triglycerides (mg/dL), glucose (mg/dL), uric acid (mg/dL), creatinine (mg/dL) and liver enzyme activities (GGT, GPT, GOT).
- Body mass index (kg/m2).
- Nutrients intake (g/day) from Food Frequency Questionnaire.
- Physical activity (MET-minutes per week) from International Physical Activity Questionnaire (IPAQ).
- Conditions
- Healthy Diet
- Being tested
- nutritional guidelines to promote healthy diet and increase fish intake
- Keywords
- canned fish, red blood cell membrane lipidomics, omega-3 fatty acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional guidelines to promote healthy diet and increase fish intakeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: nutritional guidelines to promote healthy diet and increase fish intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 months
Secondary outcomes (1)
Biochemical parameters in plasma
Blood cholesterol (mg/dL): total cholesterol, HDL-c and LDL-c Triglycerides (mg/dL) Glucose (mg/dL)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Nov 2021
- Primary completion16 Mar 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized nutritional intervention clinical trial of 2 parallel groups, in which 150 healthy adults between 18 and 65 years will be recruited.
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Arranz Martinez
- Sponsor type
- University, hospital or other
- Collaborators
- MUTUALIA S.L., OSARTEN KOOPERATIBA ELKARTEA
- Responsible party
- Sponsor-investigator, Sara Arranz Martinez, Fundacion Azti
- Investigators
- Sara Arranz, PhD, Principal investigator, Fundacion Azti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213273
- Sponsor's protocol ID
- SA-TUN-2021-01
- Acronym
- TUNACAN
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2021
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TUNACAN: Nutritional Study on the Beneficial Effects of Canned Fish Consumption on Healthy Adult Population
- ClinicalTrials.gov ID
- NCT05213273
- Acronym / sponsor ID
- TUNACAN / SA-TUN-2021-01
- Conditions
- Healthy Diet
- Keywords
- canned fish, red blood cell membrane lipidomics, omega-3 fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Sara Arranz MartinezUniversity, hospital or other
- Collaborators
- MUTUALIA S.L., OSARTEN KOOPERATIBA ELKARTEA
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 <BMI < 27 kg/m2. Those individuals who usually have a fish intake of less than 1-2 servings per week will be included.
Exclusion criteria: Having been diagnosed with concomitant diseases or chronic disease that can modify the results. Having undergone a transplant. Be taking medication and consuming or have consumed omega 3 supplements, vitamins, prebiotics.. in the last 4 months before starting the study. Allergy to fish or any food.
Sample size calculation:
The sample size was calculated with the G * power software based on the defined primary objective of observing differences in the lipid profile of the red blood cell membrane obtained after the ANCOVA test for fixed effects and interactions. A priori investigators expect a mean effect (f = 0.25) for a statistical power of 80.0% (1-β = 0.80) and taking into account that the significance level is 5.0%, it will be necessary to include 64 experimental units in the control group and 64 units in the experimental group that sum 128 experimental units in the study. Taking into account that the expected dropout percentage is around 20.0%, a total of 150 experimental units would be necessary in the study.
Primary outcome:
- Metabolic status will be evaluated measuring 12 fatty acids in 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 this fatty acids in red blood cell membranes previously reported in the litearature (Ferreri C et al. 2012. Expert Rev. Mol. Diagn. 12(7), 767-780). Secondary outcomes:
- Biochemical parameters: total cholesterol (mg/dL), HDL cholesterol (mg/dL), LDL cholesterol (mg/dL), triglycerides (mg/dL), glucose (mg/dL), uric acid (mg/dL), creatinine (mg/dL) and liver enzyme activities (GGT, GPT, GOT).
- Body mass index (kg/m2).
- Nutrients intake (g/day) from Food Frequency Questionnaire.
- Physical activity (MET-minutes per week) from International Physical Activity Questionnaire (IPAQ).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized nutritional intervention clinical trial of 2 parallel groups, in which 150 healthy adults between 18 and 65 years will be recruited.
| Arm | Type | Receives |
|---|---|---|
| Group A: Fresh/frozen fish | Experimental | Behavioral: nutritional guidelines to promote healthy diet and increase fish intakeHealthy 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. |
| Group B: Canned fish | Experimental | Behavioral: nutritional guidelines to promote healthy diet and increase fish intakeHealthy 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults (men and women)
- 18.5 <BMI <24.9.
- Individuals who habitually have a lower fish intake1-2 servings/week
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional guidelines to promote healthy diet and increase fish intakeNutritional 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. | Behavioural | Group A: Fresh/frozen fish, Group B: Canned fish |
Primary outcome
Metabolic status: RBC membrane fatty acid profile.
Time frame: 4 months
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).
1 secondary outcome
Biochemical parameters in plasma
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Sara Arranz ORCIDLink provided by the sponsor.
- AZTI web pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Arranz, PhD principal investigator
Fundacion Azti
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional guidelines to promote healthy diet and increase fish intake in people with Healthy Diet, run by Sara Arranz Martinez at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic status: RBC membrane fatty acid profile. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.