Sardine-enriched Diet for Prevention Type 2 Diabetes

Not Applicable

Completed

• Conditions: PreDiabetes; Diabetes; Diet Habit; Nutritional and Metabolic Disease; Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: Sardine; Dietary Supplement: Control

• Registration Number: NCT03557541
• Lead Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-15
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-18
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sardine group	Sardine	-
Control group	Control	-

Primary Outcome Measures

Name	Time	Method
type 2 diabetes new onset	Change from Baseline at 12 months	incidence of new diagnosis of type 2 diabetes

Secondary Outcome Measures

Name	Time	Method
adiponectin	Change from Baseline at 12 months	adiponectin levels
insulin levels	Change from Baseline at 12 months	insulin (mU/L)
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)
HOMA-IR (homeostasis model assessment insulin resistance)	Change from Baseline at 12 months	insulin resistance index
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 \[log2 (fold change)\]
glucose homeostasis	Change from Baseline at 12 months	glucose (mg/dl)
HOMA-B (homeostasis model assessment B cell function)	Change from Baseline at 12 months	B cella function

Trial Locations

Locations (1)

Diana A Diaz Rizzolo; 🇪🇸 Barcelona, Spain