A Sardine Diet Intervention Study to Assess Benefits to the Metabolic Profile in Type 2 Diabetes Mellitus Patients
NCT ID: NCT02294526
Last Updated: 2015-01-29
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
35 participants
INTERVENTIONAL
2012-11-30
2013-11-30
Brief Summary
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A diet rich in sardine will improve the metabolic control in type 2 diabetes patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sardine diet
Subjects follow general dietary recommendations for diabetes including a fixed amount of sardine in daily meals (100g per day, 5 days a week) as part of their usual diet.
Sardine diet
Diet rich in sardine: 100g/day of sardine 5 times a week
Control diet
Subjects only follow general dietary recommendations for diabetes.
No interventions assigned to this group
Interventions
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Sardine diet
Diet rich in sardine: 100g/day of sardine 5 times a week
Eligibility Criteria
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Inclusion Criteria
* BMI ≥ 25 and \< 35
* Patients diagnosed with type 2 diabetes at onset or treated only by diet
* HbA1c between 6.0 and 8.0% (based on the last measured and documented laboratory measurement of the previous 3 months)
* Usual consumption ≤ 3 fish per week
Exclusion Criteria
* Current or previous (within 3 months) intake of omega 3 suplements
* Known allergy or intolerance to fish or fish protein
* Diagnosis of active neoplasic disease
* Suffering from an acute illness which requires a recovery period higher than one week
* Currently chronic treatment with oral steroids or nonesteroidal anti-inflammatory for more than 5 days, at least 1 month before randomization
* Pregnant or breast-feeding patients
* Serious acute vascular events (cardiac or cerebral) diagnosed previous 2 months before the randomization
* Current or previous (within 6 months) participation in another study
* Chronic renal insufficiency (creatinine \>1,5 mg/dl)
* Any conditions that the investigator considers may render the patient unable to complete the study
During the interventional study, based on current standards of T2D care, doctors will introduce anti-diabetic oral drugs or insulin into the patient's treatment, where they consider it to be necessary.
40 Years
85 Years
ALL
No
Sponsors
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Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
OTHER
Responsible Party
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Principal Investigators
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Ramon Gomis, Professor
Role: PRINCIPAL_INVESTIGATOR
CIBERDEM - IDIBAPS (Institut d'Investigacions Biomèdiques August Pi i Sunyer) - Hospital Clínic of Barcelona
References
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Balfego M, Canivell S, Hanzu FA, Sala-Vila A, Martinez-Medina M, Murillo S, Mur T, Ruano EG, Linares F, Porras N, Valladares S, Fontalba M, Roura E, Novials A, Hernandez C, Aranda G, Siso-Almirall A, Rojo-Martinez G, Simo R, Gomis R. Effects of sardine-enriched diet on metabolic control, inflammation and gut microbiota in drug-naive patients with type 2 diabetes: a pilot randomized trial. Lipids Health Dis. 2016 Apr 18;15:78. doi: 10.1186/s12944-016-0245-0.
Other Identifiers
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CIBERDEM-PILCHARDUS
Identifier Type: -
Identifier Source: org_study_id
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