A Sardine Diet Intervention Study to Assess Benefits to the Metabolic Profile in Type 2 Diabetes Mellitus Patients (PILCHARDUS)

Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Other: Sardine diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02294526

CIBERDEM-PILCHARDUS

Details and patient eligibility

About

Work hypothesis

A diet rich in sardine will improve the metabolic control in type 2 diabetes patients.

Enrollment: 35 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 40 years and < 85
• 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

• T2D treated with antidiabetic oral drugs and/or insulin
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Sardine diet

Experimental group

Description:

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.

Treatment:

Other: Sardine diet

Control diet

No Intervention group

Description:

Subjects only follow general dietary recommendations for diabetes.