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Sardine-enriched Diet for Prevention Type 2 Diabetes

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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

Tracking Information
First Submitted Date  ICMJE March 21, 2018
First Posted Date  ICMJE June 15, 2018
Last Update Posted Date July 19, 2018
Actual Study Start Date  ICMJE May 2014
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
type 2 diabetes new onset [ Time Frame: Change from Baseline at 12 months ]
incidence of new diagnosis of type 2 diabetes
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
  • adiponectin [ Time Frame: Change from Baseline at 12 months ]
    adiponectin levels
  • quantification of gut microbiota populations [ Time Frame: Change from Baseline at 12 months ]
    quantification by q-PCR
  • 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)
  • 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)]
  • glucose homeostasis [ Time Frame: Change from Baseline at 12 months ]
    glucose (mg/dl)
  • insulin levels [ Time Frame: Change from Baseline at 12 months ]
    insulin (mU/L)
  • HOMA-IR (homeostasis model assessment insulin resistance) [ Time Frame: Change from Baseline at 12 months ]
    insulin resistance index
  • HOMA-B (homeostasis model assessment B cell function) [ Time Frame: Change from Baseline at 12 months ]
    B cella function
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sardine-enriched Diet for Prevention Type 2 Diabetes
Official Title  ICMJE Sardine-enriched Diet for Prevention Type 2 Diabetes in Elderly and Prediabetic Population
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • PreDiabetes
  • Diet Habit
  • Diabetes
  • Nutritional and Metabolic Disease
Intervention  ICMJE
  • Dietary Supplement: Sardine
    They received 200gr of canned sardine in olive oil per week (+a common T2D-preventive diet)
  • Dietary Supplement: Control
    They received a common T2D-preventive diet
Study Arms  ICMJE
  • Experimental: Sardine group
    Intervention: Dietary Supplement: Sardine
  • Active Comparator: Control group
    Intervention: Dietary Supplement: Control
Publications * Díaz-Rizzolo DA, Serra A, Colungo C, Sala-Vila A, Sisó-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2018)
182
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03557541
Other Study ID Numbers  ICMJE 2013/8863
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Diana Alicia Diaz Rizzolo, Institut d'Investigacions Biomèdiques August Pi i Sunyer
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Institut d'Investigacions Biomèdiques August Pi i Sunyer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut d'Investigacions Biomèdiques August Pi i Sunyer
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP