Trial | NCT03557541  Report issue

Title

Sardine-enriched Diet for Prevention Type 2 Diabetes
Sardine-enriched Diet for Prevention Type 2 Diabetes in Elderly and Prediabetic Population

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    Sardine ...

  • Study Participants

    182
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.
Study Started
May 31
2014
Primary Completion
Jul 31
2017
Study Completion
Jul 31
2017
Last Update
Jul 19
2018

Dietary Supplement Sardine

They received 200gr of canned sardine in olive oil per week (+a common T2D-preventive diet)

Dietary Supplement Control

They received a common T2D-preventive diet

Sardine group Experimental

Control group Active Comparator

Criteria 

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.
No Results Posted