NCT03557541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

3.2 years

First QC Date

March 21, 2018

Last Update Submit

July 18, 2018

Conditions

Diabetes Mellitus, Type 2PreDiabetesDiet HabitDiabetesNutritional and Metabolic Disease

Keywords

diabetesT2Ddietnutritionprediabetessardineelderly

Outcome Measures

Primary Outcomes (1)

  • type 2 diabetes new onset

    incidence of new diagnosis of type 2 diabetes

    Change from Baseline at 12 months

Secondary Outcomes (8)

  • adiponectin

    Change from Baseline at 12 months

  • quantification of gut microbiota populations

    Change from Baseline at 12 months

  • gene expression

    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.]

    Change from Baseline at 12 months

  • glucose homeostasis

    Change from Baseline at 12 months

  • +3 more secondary outcomes

Study Arms (2)

Sardine group

EXPERIMENTAL
Dietary Supplement: Sardine

Control group

ACTIVE COMPARATOR
Dietary Supplement: Control

Interventions

SardineDIETARY_SUPPLEMENT

They received 200gr of canned sardine in olive oil per week (+a common T2D-preventive diet)

Sardine group
ControlDIETARY_SUPPLEMENT

They received a common T2D-preventive diet

Control group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • glycaemia between 100-125 md / dL or ≥5.7% HbA1c

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diana A Diaz Rizzolo

Barcelona, 08036, Spain

Location

Related Publications (1)

  • 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.

    PMID: 33932804DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic StateFeeding BehaviorDiabetes MellitusMetabolic Diseases

Interventions

calcitonin, sardine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RD, Msc, PhD candidate

Study Record Dates

First Submitted

March 21, 2018

First Posted

June 15, 2018

Study Start

May 1, 2014

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 19, 2018

Record last verified: 2018-07

Locations

ES(1)