Sardine-enriched Diet for Prevention Type 2 Diabetes | NCT03557541

Studies
Sardine-enriched Diet for Prevention Type 2 Diabetes

NCT03557541

Sponsor

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Status

Completed

Last Update Posted

Jul 19, 2018Actual

Enrollment

182Actual

Phase

Not Applicable

Conditions

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

Interventions

Sardine
Control

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014Actual

Primary Completion Date

Jul 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Mar 21, 2018

First Submission Date that Met QC Criteria

Jun 4, 2018

First Posted Date

Jun 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2018

Last Update Posted Date

Jul 19, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Diana Alicia Diaz Rizzolo, RD, Msc, PhD candidate, Institut d'Investigacions Biomèdiques August Pi i SunyerPrincipal Investigator

Lead Sponsor

Institut d'Investigacions Biomèdiques August Pi i SunyerOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

182Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sardine group	Experimental		Dietary Supplement: Sardine
Control group	Active Comparator		Dietary Supplement: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sardine	Dietary Supplement	They received 200gr of canned sardine in olive oil per week (+a common T2D-preventive diet)	Sardine group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
adiponectin	adiponectin levels	Change from Baseline at 12 months
quantification of gut microbiota populations	quantification by q-PCR

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Diana A Diaz Rizzolo		Barcelona		08036	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33932804	Derived	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Nov 28, 2013	Jul 17, 2018	ICF_000.pdf
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 28, 2013	Jul 18, 2018	Prot_SAP_001.pdf

ID	Term
D003924	Diabetes Mellitus, Type 2
D011236	Prediabetic State
D005247	Feeding Behavior
D003920	Diabetes Mellitus
D008659	Metabolic Diseases

ID	Term
D044882	Glucose Metabolism Disorders
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001522	Behavior, Animal