Sardine-enriched Diet for Prevention Type 2 Diabetes

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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes; PreDiabetes; Diet Habit; Nutritional and Metabolic Disease
• Intervention / Treatment: Dietary supplement: Sardine; Dietary supplement: Control

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Diana A Diaz Rizzolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer

Publications and helpful links

General Publications

• Diaz-Rizzolo DA, Serra A, Colungo C, Sala-Vila A, Siso-Almirall A, Gomis R. Type 2 diabetes preventive effects with a 12-months sardine-enriched diet in elderly population with prediabetes: An interventional, randomized and controlled trial. Clin Nutr. 2021 May;40(5):2587-2598. doi: 10.1016/j.clnu.2021.03.014. Epub 2021 Mar 18.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: diabetes; nutrition; elderly; diet; prediabetes; T2D; sardine
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance; Metabolic Diseases
• Other Study ID Numbers: 2013/8863

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No