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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
182
Diana A Diaz Rizzolo
Barcelona, Spain
type 2 diabetes new onset
incidence of new diagnosis of type 2 diabetes
Time frame: Change from Baseline at 12 months
adiponectin
adiponectin levels
Time frame: Change from Baseline at 12 months
quantification of gut microbiota populations
quantification by q-PCR
Time frame: Change from Baseline at 12 months
gene expression
relative expression related genes by RT q-PCR (Real Time Quantitative Reverse transcription polymerase chain reaction)
Time frame: Change from Baseline at 12 months
metabolomics study of dietary biomarkers and health biomarkers [(1) Fatty acyls, bile acids, steroids and lysoglycerophospholipids, (2) Glycerolipids, glycerophospholipids, sterol lipids and sphingolipids, (3) Amino acids.]
endogenous metabolic profiles of serum samples will be studied using ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS). The same unit for measurements \[log2 (fold change)\]
Time frame: Change from Baseline at 12 months
glucose homeostasis
glucose (mg/dl)
Time frame: Change from Baseline at 12 months
insulin levels
insulin (mU/L)
Time frame: Change from Baseline at 12 months
HOMA-IR (homeostasis model assessment insulin resistance)
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insulin resistance index
Time frame: Change from Baseline at 12 months
HOMA-B (homeostasis model assessment B cell function)
B cella function
Time frame: Change from Baseline at 12 months