Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
182 participants
INTERVENTIONAL
2014-05-31
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Sardine group
Sardine
They received 200gr of canned sardine in olive oil per week (+a common T2D-preventive diet)
Control group
Control
They received a common T2D-preventive diet
Interventions
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Sardine
They received 200gr of canned sardine in olive oil per week (+a common T2D-preventive diet)
Control
They received a common T2D-preventive diet
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* any nutritional education to prevent T2D
* Suspect or known hypersensitivity to sardine or related fish
* Chronic treatment with oral steroids and / or AINES
* Treatment with oral antidiabetic agents and / or insulin
* Treatment with immunosuppressive drugs
* Diagnosis of active neoplasm
* Diagnosis of HIV or AIDS
* Abnormal liver profile (\> 6 times normal values)
* Diagnosis of Acute Psychiatric Sdr
* Presence of serious acute concomitant disease, which it requires more than 7 days of recovery.
* Major cardiovascular event (stroke, myocardial infarction) in the month prior to randomization.
* Any other condition that the investigator considers to be inoperative so that the subject conducts the study.
65 Years
ALL
Yes
Sponsors
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Institut d'Investigacions Biomèdiques August Pi i Sunyer
OTHER
Responsible Party
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Diana Alicia Diaz Rizzolo
RD, Msc, PhD candidate
Locations
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Diana A Diaz Rizzolo
Barcelona, , Spain
Countries
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References
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Diaz-Rizzolo DA, Serra A, Colungo C, Sala-Vila A, Siso-Almirall A, Gomis R. Type 2 diabetes preventive effects with a 12-months sardine-enriched diet in elderly population with prediabetes: An interventional, randomized and controlled trial. Clin Nutr. 2021 May;40(5):2587-2598. doi: 10.1016/j.clnu.2021.03.014. Epub 2021 Mar 18.
Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2013/8863
Identifier Type: -
Identifier Source: org_study_id
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