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

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

Work hypothesis

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Sardine diet

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Sardine diet; Diet rich in sardine: 100g/day of sardine 5 times a week
No Intervention: Control diet; Subjects only follow general dietary recommendations for diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in glycated hemoglobin (HbA1c) at 6 months	Baseline and 6 months
Change from baseline in fasting glucose at 6 months	Baseline and 6 months
Change from baseline in fasting insulin at 6 months	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in adiponectin at 6 months	Baseline and 6 months
Change from baseline in leptin at 6 months	Baseline and 6 months
Change from baseline in ultra sensitive C-reactive protein (us-CRP) at 6 months	Baseline and 6 months
Change from baseline in interleukin-6 (IL-6) at 6 months	Baseline and 6 months
Change from baseline in interleukin-8 (IL-8) at 6 months	Baseline and 6 months
Change from baseline in interleukin-10 (IL-10) at 6 months	Baseline and 6 months
Change from baseline in tumor necrosis factor alpha (TNFα) at 6 months	Baseline and 6 months
Change from baseline in erytrocite membrane fatty acid composition (EMFA) at 6 months	Baseline and 6 months
Change from baseline in specific bacterial groups of gut microbiota at 6 months	Baseline and 6 months
Change from baseline in total cholesterol at 6 months	Baseline and 6 months
Change from baseline in LDL cholesterol at 6 months	Baseline and 6 months
Change from baseline in HDL cholesterol at 6 months	Baseline and 6 months
Change from baseline in triglycerides at 6 months	Baseline and 6 months
Change from baseline in blood pressure at 6 months	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
• Investigators: Principal Investigator: Ramon Gomis, Professor, CIBERDEM - IDIBAPS (Institut d'Investigacions Biomèdiques August Pi i Sunyer) - Hospital Clínic of Barcelona

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 31, 2014
• First Submitted That Met QC Criteria: November 16, 2014
• First Posted (Estimate): November 19, 2014

Study Record Updates

• Last Update Posted (Estimate): January 29, 2015
• Last Update Submitted That Met QC Criteria: January 28, 2015
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Diet; Sardine
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CIBERDEM-PILCHARDUS