Diabetes, Diabetes Mellitus, Type 2, Diet Habit, Nutritional and Metabolic Disease, PreDiabetes
Conditions
Keywords
diabetes, T2D, diet, nutrition, prediabetes, sardine, elderly
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTSardine
They received 200gr of canned sardine in olive oil per week (+a common T2D-preventive diet)
DIETARY_SUPPLEMENTControl
They received a common T2D-preventive diet
Sponsors
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| type 2 diabetes new onset | Change from Baseline at 12 months | incidence of new diagnosis of type 2 diabetes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quantification of gut microbiota populations | Change from Baseline at 12 months | quantification by q-PCR |
| gene expression | Change from Baseline at 12 months | relative expression related genes by RT q-PCR (Real Time Quantitative Reverse transcription polymerase chain reaction) |
| 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.] | Change from Baseline at 12 months | endogenous metabolic profiles of serum samples will be studied using ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS). The same unit for measurements \[log2 (fold change)\] |
| adiponectin | Change from Baseline at 12 months | adiponectin levels |
| insulin levels | Change from Baseline at 12 months | insulin (mU/L) |
| HOMA-IR (homeostasis model assessment insulin resistance) | Change from Baseline at 12 months | insulin resistance index |
| HOMA-B (homeostasis model assessment B cell function) | Change from Baseline at 12 months | B cella function |
| glucose homeostasis | Change from Baseline at 12 months | glucose (mg/dl) |
Countries
Spain
Outcome results
None listed