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Completed

NCT Number: NCT03557541

Sardine-enriched Diet for Prevention Type 2 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Behavior, Animal Diabetes Diabetes Mellitus Diet Habit Endocrine System Diseases Feeding Behavior Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Disease Nutritional and Metabolic Diseases PreDiabetes Prediabetic State

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diana A Diaz Rizzolo

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sardine

Dietary Supplement

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

Control

Dietary Supplement

They received a common T2D-preventive diet

Primary outcomes

  1. type 2 diabetes new onset

    Time frame: Change from Baseline at 12 months

    incidence of new diagnosis of type 2 diabetes

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 15, 2018
Registry last updated
Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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