Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sardine-enriched Diet for Prevention Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03557541
Recruitment Status : Completed
First Posted : June 15, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Diana Alicia Diaz Rizzolo, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 PreDiabetes Diet Habit Diabetes Nutritional and Metabolic Disease Dietary Supplement: Sardine Dietary Supplement: Control Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sardine-enriched Diet for Prevention Type 2 Diabetes in Elderly and Prediabetic Population
Actual Study Start Date : May 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sardine group Dietary Supplement: Sardine
They received 200gr of canned sardine in olive oil per week (+a common T2D-preventive diet)

Active Comparator: Control group Dietary Supplement: Control
They received a common T2D-preventive diet




Primary Outcome Measures :
  1. type 2 diabetes new onset [ Time Frame: Change from Baseline at 12 months ]
    incidence of new diagnosis of type 2 diabetes


Secondary Outcome Measures :
  1. adiponectin [ Time Frame: Change from Baseline at 12 months ]
    adiponectin levels

  2. quantification of gut microbiota populations [ Time Frame: Change from Baseline at 12 months ]
    quantification by q-PCR

  3. gene expression [ Time Frame: Change from Baseline at 12 months ]
    relative expression related genes by RT q-PCR (Real Time Quantitative Reverse transcription polymerase chain reaction)

  4. 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.] [ Time Frame: 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)]

  5. glucose homeostasis [ Time Frame: Change from Baseline at 12 months ]
    glucose (mg/dl)

  6. insulin levels [ Time Frame: Change from Baseline at 12 months ]
    insulin (mU/L)

  7. HOMA-IR (homeostasis model assessment insulin resistance) [ Time Frame: Change from Baseline at 12 months ]
    insulin resistance index

  8. HOMA-B (homeostasis model assessment B cell function) [ Time Frame: Change from Baseline at 12 months ]
    B cella function



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557541


Locations
Layout table for location information
Spain
Diana A Diaz Rizzolo
Barcelona, Spain, 08036
Sponsors and Collaborators
Institut d'Investigacions Biomèdiques August Pi i Sunyer
  Study Documents (Full-Text)

Documents provided by Diana Alicia Diaz Rizzolo, Institut d'Investigacions Biomèdiques August Pi i Sunyer:
Informed Consent Form  [PDF] November 28, 2013

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Diana Alicia Diaz Rizzolo, RD, Msc, PhD candidate, Institut d'Investigacions Biomèdiques August Pi i Sunyer
ClinicalTrials.gov Identifier: NCT03557541    
Other Study ID Numbers: 2013/8863
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Diana Alicia Diaz Rizzolo, Institut d'Investigacions Biomèdiques August Pi i Sunyer:
diabetes
T2D
diet
nutrition
prediabetes
sardine
elderly
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Intolerance
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases
Hyperglycemia