Sardine-enriched Diet for Prevention Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03557541
• Other study ID #: 2013/8863
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: July 2017

Study information

• Verified date: July 2018
• Source: Institut d'Investigacions Biomèdiques August Pi i Sunyer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diet Habit
• Glucose Intolerance
• Metabolic Diseases
• Nutritional and Metabolic Disease
• PreDiabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Sardine
They received 200gr of canned sardine in olive oil per week (+a common T2D-preventive diet)
• Control
They received a common T2D-preventive diet

Locations

Country	Name	City	State
Spain	Diana A Diaz Rizzolo	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Investigacions Biomèdiques August Pi i Sunyer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	type 2 diabetes new onset	incidence of new diagnosis of type 2 diabetes	Change from Baseline at 12 months
Secondary	adiponectin	adiponectin levels	Change from Baseline at 12 months
Secondary	quantification of gut microbiota populations	quantification by q-PCR	Change from Baseline at 12 months
Secondary	gene expression	relative expression related genes by RT q-PCR (Real Time Quantitative Reverse transcription polymerase chain reaction)	Change from Baseline at 12 months
Secondary	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
Secondary	glucose homeostasis	glucose (mg/dl)	Change from Baseline at 12 months
Secondary	insulin levels	insulin (mU/L)	Change from Baseline at 12 months
Secondary	HOMA-IR (homeostasis model assessment insulin resistance)	insulin resistance index	Change from Baseline at 12 months
Secondary	HOMA-B (homeostasis model assessment B cell function)	B cella function	Change from Baseline at 12 months