Sardine-enriched Diet for Prevention Type 2 Diabetes

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Status: Completed

Conditions: Diabetes; Diet Habit; Nutritional and Metabolic Disease; Diabetes Mellitus, Type 2; PreDiabetes

Treatments: Dietary Supplement: Sardine; Dietary Supplement: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03557541

2013/8863

Details and patient eligibility

About

The hypothesis formulated is that 200 g of sardine on a weekly basis will have a favourable impact avoiding the natural development of the pathology due to changes in the biochemical profile, the anthropometrics, inflammatory markers, changes in gut microbiota populations, also in transcriptomics and metabolomics.

Enrollment: 182 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• glycaemia between 100-125 md / dL or ≥5.7% HbA1c

Exclusion criteria

• treatment with oral antidiabetic drugs
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

Sardine group

Experimental group

Treatment:

Dietary Supplement: Sardine

Control group

Active Comparator group

Treatment:

Dietary Supplement: Control