Sardine-enriched Diet for Prevention Type 2 Diabetes

• ClinicalTrials.gov Identifier: NCT03557541
• Recruitment Status: Completed
• First Posted: June 15, 2018
• Last Update Posted: July 19, 2018
• Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer
• Information provided by (Responsible Party): Diana Alicia Diaz Rizzolo, Institut d'Investigacions Biomèdiques August Pi i Sunyer

Tracking Information

• First Submitted Date: March 21, 2018
• First Posted Date: June 15, 2018
• Last Update Posted Date: July 19, 2018
• Actual Study Start Date: May 2014
• Actual Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sardine-enriched Diet for Prevention Type 2 Diabetes
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

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

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 4, 2018): 182
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: July 2017
• Actual Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT03557541
• Other Study ID Numbers: 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: 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: Institut d'Investigacions Biomèdiques August Pi i Sunyer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Institut d'Investigacions Biomèdiques August Pi i Sunyer
• Verification Date: July 2018