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Sardine-enriched Diet for Prevention Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2, PreDiabetes, Diet Habit

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Sardine
Control
Sponsored by
Institut d'Investigacions Biomèdiques August Pi i Sunyer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring diabetes, T2D, diet, nutrition, prediabetes, sardine, elderly

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Diana A Diaz Rizzolo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sardine group

Control group

Arm Description

Outcomes

Primary Outcome Measures

type 2 diabetes new onset
incidence of new diagnosis of type 2 diabetes

Secondary Outcome Measures

adiponectin
adiponectin levels
quantification of gut microbiota populations
quantification by q-PCR
gene expression
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.]
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
glucose (mg/dl)
insulin levels
insulin (mU/L)
HOMA-IR (homeostasis model assessment insulin resistance)
insulin resistance index
HOMA-B (homeostasis model assessment B cell function)
B cella function

Full Information

First Posted
March 21, 2018
Last Updated
July 18, 2018
Sponsor
Institut d'Investigacions Biomèdiques August Pi i Sunyer
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1. Study Identification

Unique Protocol Identification Number
NCT03557541
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut d'Investigacions Biomèdiques August Pi i Sunyer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, PreDiabetes, Diet Habit, Diabetes, Nutritional and Metabolic Disease
Keywords
diabetes, T2D, diet, nutrition, prediabetes, sardine, elderly

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sardine group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Sardine
Intervention Description
They received 200gr of canned sardine in olive oil per week (+a common T2D-preventive diet)
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
They received a common T2D-preventive diet
Primary Outcome Measure Information:
Title
type 2 diabetes new onset
Description
incidence of new diagnosis of type 2 diabetes
Time Frame
Change from Baseline at 12 months
Secondary Outcome Measure Information:
Title
adiponectin
Description
adiponectin levels
Time Frame
Change from Baseline at 12 months
Title
quantification of gut microbiota populations
Description
quantification by q-PCR
Time Frame
Change from Baseline at 12 months
Title
gene expression
Description
relative expression related genes by RT q-PCR (Real Time Quantitative Reverse transcription polymerase chain reaction)
Time Frame
Change from Baseline at 12 months
Title
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.]
Description
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)]
Time Frame
Change from Baseline at 12 months
Title
glucose homeostasis
Description
glucose (mg/dl)
Time Frame
Change from Baseline at 12 months
Title
insulin levels
Description
insulin (mU/L)
Time Frame
Change from Baseline at 12 months
Title
HOMA-IR (homeostasis model assessment insulin resistance)
Description
insulin resistance index
Time Frame
Change from Baseline at 12 months
Title
HOMA-B (homeostasis model assessment B cell function)
Description
B cella function
Time Frame
Change from Baseline at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Diana A Diaz Rizzolo
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33932804
Citation
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.
Results Reference
derived

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Sardine-enriched Diet for Prevention Type 2 Diabetes

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