Clinical trial NCT03557541: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
PreDiabetes
Diet Habit
Diabetes
Nutritional and Metabolic Disease
Keywords: diabetes
T2D
diet
nutrition
prediabetes
sardine
elderly
Lead sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 182
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: type 2 diabetes new onset
timeFrame: Change from Baseline at 12 months
Secondary outcomes:
measure: adiponectin
timeFrame: Change from Baseline at 12 months
measure: quantification of gut microbiota populations
timeFrame: Change from Baseline at 12 months
measure: gene expression
timeFrame: Change from Baseline at 12 months
measure: 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.]
timeFrame: Change from Baseline at 12 months
measure: glucose homeostasis
timeFrame: Change from Baseline at 12 months
measure: insulin levels
timeFrame: Change from Baseline at 12 months
measure: HOMA-IR (homeostasis model assessment insulin resistance)
timeFrame: Change from Baseline at 12 months
measure: HOMA-B (homeostasis model assessment B cell function)
timeFrame: Change from Baseline at 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Diana A Diaz Rizzolo
Study officials:
References:
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.