Diabetes Mellitus, Type 2NCT03557541
Sardine-enriched Diet for Prevention Type 2 Diabetes
A study testing Sardine in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Institut d'Investigacions Biomèdiques August Pi i Sunyer at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, PreDiabetes, Diet Habit
- What is being tested?
- Sardine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteSpain
- Study dates
- May 2014to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- glycaemia between 100-125 md / dL or ≥5.7% HbA1c
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sardine-enriched Diet for Prevention Type 2 Diabetes in Elderly and Prediabetic Population
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.
- Conditions
- Diabetes Mellitus, Type 2, PreDiabetes, Diet Habit, Diabetes, Nutritional and Metabolic Disease
- Being tested
- Sardine, Control
- Keywords
- diabetes, T2D, diet, nutrition, prediabetes, sardine, elderly
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Feeding Behavior, Diabetes Mellitus, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SardineDietary supplement
They received 200gr of canned sardine in olive oil per week (+a common T2D-preventive diet)
ControlDietary supplement
They received a common T2D-preventive diet
| Study group | Role | What they receive |
|---|---|---|
| Sardine group | Experimental | Not described Receives: Dietary Supplement: Sardine |
| Control group | Active comparator | Not described Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
type 2 diabetes new onset
incidence of new diagnosis of type 2 diabetes
Measured: Change from Baseline at 12 months
Secondary outcomes (8)
adiponectin
adiponectin levels
Measured: Change from Baseline at 12 months
quantification of gut microbiota populations
quantification by q-PCR
Measured: Change from Baseline at 12 months
gene expression
relative expression related genes by RT q-PCR (Real Time Quantitative Reverse transcription polymerase chain reaction)
Measured: Change from Baseline at 12 months
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)]
Measured: Change from Baseline at 12 months
glucose homeostasis
glucose (mg/dl)
Measured: Change from Baseline at 12 months
insulin levels
insulin (mU/L)
Measured: Change from Baseline at 12 months
HOMA-IR (homeostasis model assessment insulin resistance)
insulin resistance index
Measured: Change from Baseline at 12 months
HOMA-B (homeostasis model assessment B cell function)
B cella function
Measured: Change from Baseline at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study startMay 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Alicia Diaz Rizzolo, Institut d'Investigacions Biomèdiques August Pi i Sunyer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557541
- Sponsor's protocol ID
- 2013/8863
- Status last verified
- Jul 2018
- First submitted
- 21 Mar 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33932804
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sardine-enriched Diet for Prevention Type 2 Diabetes in Elderly and Prediabetic Population
- ClinicalTrials.gov ID
- NCT03557541
- Acronym / sponsor ID
- 2013/8863
- Conditions
- Diabetes Mellitus, Type 2, PreDiabetes, Diet Habit, Diabetes, Nutritional and Metabolic Disease
- Keywords
- diabetes, T2D, diet, nutrition, prediabetes, sardine, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Institut d'Investigacions Biomèdiques August Pi i SunyerUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sardine group | Experimental | Dietary Supplement: Sardine |
| Control group | Active comparator | Dietary Supplement: Control |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- glycaemia between 100-125 md / dL or ≥5.7% HbA1c
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SardineThey received 200gr of canned sardine in olive oil per week (+a common T2D-preventive diet) | Dietary supplement | Sardine group |
| ControlThey received a common T2D-preventive diet | Dietary supplement | Control group |
Primary outcome
type 2 diabetes new onset
Time frame: Change from Baseline at 12 months
incidence of new diagnosis of type 2 diabetes
8 secondary outcomes
adiponectin
Time frame: Change from Baseline at 12 months
quantification of gut microbiota populations
Time frame: Change from Baseline at 12 months
gene expression
Time frame: Change from Baseline at 12 months
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
glucose homeostasis
Time frame: Change from Baseline at 12 months
insulin levels
Time frame: Change from Baseline at 12 months
HOMA-IR (homeostasis model assessment insulin resistance)
Time frame: Change from Baseline at 12 months
HOMA-B (homeostasis model assessment B cell function)
Time frame: Change from Baseline at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Derived from this study: PubMed 33932804Diaz-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sardine in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Institut d'Investigacions Biomèdiques August Pi i Sunyer at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
type 2 diabetes new onset (time frame: Change from Baseline at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03557541, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.