Sardine-enriched Diet for Prevention Type 2 Diabetes

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Dietary Supplement: Sardine
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sardine group<br> | Dietary Supplement: Sardine<br>* They received 200gr of canned sardine in olive oil per week (+a common T2D-preventive diet)<br>|
| Active Comparator: Control group<br> | Dietary Supplement: Control<br>* They received a common T2D-preventive diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| type 2 diabetes new onset | incidence of new diagnosis of type 2 diabetes | Change from Baseline at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adiponectin | adiponectin levels | Change from Baseline at 12 months | 
| quantification of gut microbiota populations | quantification by q-PCR | Change from Baseline at 12 months | 
| gene expression | relative expression related genes by RT q-PCR (Real Time Quantitative Reverse transcription polymerase chain reaction) | 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)] | Change from Baseline at 12 months | 
| glucose homeostasis | glucose (mg/dl) | Change from Baseline at 12 months | 
| insulin levels | insulin (mU/L) | Change from Baseline at 12 months | 
| HOMA-IR (homeostasis model assessment insulin resistance) | insulin resistance index | Change from Baseline at 12 months | 
| HOMA-B (homeostasis model assessment B cell function) | B cella function | Change from Baseline at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T2D, diabetes, diet, nutrition, prediabetes, sardine, elderly