Gestational DiabetesOLIDIAGNCT05120388
Effect of Extra Virgin Olive Oil Addition in the Diet of Women With Gestational Diabetes Mellitus (OLIDIAG)
A study testing Extra Virgin Olive Oil Addition in people with Gestational Diabetes, run by Center for Pharmacological and Botanical Research at 1 site in Argentina.
Trial summary
Gestational diabetes mellitus (GDM) is associated to adverse maternal and neonatal outcomes. The aim of this study is to address whether the addition of extra virgin olive oil to the diet of women with GDM improves maternal triglyceridemia and reduces insulin requirement and diagnosis of diabetes at postnatal… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Extra Virgin Olive Oil Addition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteArgentina
- Study dates
- 11 Jan 2022to 19 Aug 2024
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- GDM (diagnosis criteria of the Latin American Society of Diabetes (ALAD) and Argentine Society of Diabetes (SAD): Fasting plasma glucosa > 100 mg/dl, p75 oral glucose tolerance test-2 h plasma glucose > 140 mg/dl)
Who cannot join
- Multiple pregnancy
- Pregestational diabetes (type 1 or type 2)
- Bariatric surgery
- Infectious diseases
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Unidad Patagonica de Medicina Maternofetal y Embarazo de Alto Riesgo
Neuquén, Neuquén Province, Q8300BCI
About this study
Gestational diabetes mellitus (GDM) is associated to adverse maternal and neonatal outcomes. The aim of this study is to address whether the addition of extra virgin olive oil to the diet of women with GDM improves maternal triglyceridemia and reduces insulin requirement and diagnosis of diabetes at postnatal reclassification.
Read the detailed description
This study is a randomized trial in which 1200 pregnant women at GDM diagnosis from 16 health care centers will be recruited and randomized in two parallel arms: 1 World Health Organization (WHO)-diet supplemented with 3 tablespoons of Extra Virgin Olive Oil (Intervention Group, n=600); 2. WHO-diet with no Extra Virgin Olive Oil supplementation (Control Group, n=600). Expected results: the investigators expect that the intervention will contribute to improve maternal lipid profile, reduce insulin requirement and reduce maternal diagnosis of diabetes at postpartum reclassification. Thus, this study is expected to identify maternal beneficial effects of this dietary intervention.
- Conditions
- Gestational Diabetes
- Being tested
- Extra Virgin Olive Oil Addition
- Keywords
- GDM, Extra Virgin Olive Oil, lipid profile, insulin requirement, postpartum reclassification
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra Virgin Olive Oil AdditionDietary supplement
Daily dietary addition of olive oil (three tablespoons)
| Study group | Role | What they receive |
|---|---|---|
| Dietary addition of extra virgin olive oil | Experimental | WHO diet with a daily addition of extra virgin olive oil Receives: Dietary Supplement: Extra Virgin Olive Oil Addition |
| No addition of extra virgin Olive Oil | No intervention | WHO diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal triglyceridemia
triglycerides in mg/dl
Measured: term pregnancy
maternal weight gain
gestational maternal weight gain in kg
Measured: change from prepregnancy weight to term pregnancy weight
number of participants with insulin requirement
insulin use
Measured: term pregnancy
Secondary outcomes (1)
number of participants with diabetes at postpartum
maternal diagnosis of diabetes at postpartum
Measured: six weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start11 Jan 2022
- Primary completion15 Apr 2024
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies 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
- Model description
- Dietary intervention study: GDM patients receiving a WHO diet with or without addition of extra virgin olive oil
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Pharmacological and Botanical Research
- Sponsor type
- Other government
- Collaborators
- Sociedad Argentina de Diabetes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120388
- Sponsor's protocol ID
- 11012021
- Acronym
- OLIDIAG
- Status last verified
- Aug 2024
- First submitted
- 14 Oct 2021
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extra Virgin Olive Oil Addition in the Diet of Women With Gestational Diabetes Mellitus (OLIDIAG)
- ClinicalTrials.gov ID
- NCT05120388
- Acronym / sponsor ID
- OLIDIAG / 11012021
- Conditions
- Gestational Diabetes
- Keywords
- GDM, Extra Virgin Olive Oil, lipid profile, insulin requirement, postpartum reclassification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Center for Pharmacological and Botanical ResearchOther government
- Collaborators
- Sociedad Argentina de Diabetes
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 15 Nov 2021 (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.
Gestational diabetes mellitus (GDM) is associated to adverse maternal and neonatal outcomes. The aim of this study is to address whether the addition of extra virgin olive oil to the diet of women with GDM improves maternal triglyceridemia and reduces insulin requirement and diagnosis of diabetes at postnatal reclassification.
Detailed description
This study is a randomized trial in which 1200 pregnant women at GDM diagnosis from 16 health care centers will be recruited and randomized in two parallel arms: 1 World Health Organization (WHO)-diet supplemented with 3 tablespoons of Extra Virgin Olive Oil (Intervention Group, n=600); 2. WHO-diet with no Extra Virgin Olive Oil supplementation (Control Group, n=600). Expected results: the investigators expect that the intervention will contribute to improve maternal lipid profile, reduce insulin requirement and reduce maternal diagnosis of diabetes at postpartum reclassification. Thus, this study is expected to identify maternal beneficial effects of this dietary intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Dietary intervention study: GDM patients receiving a WHO diet with or without addition of extra virgin olive oil
| Arm | Type | Receives |
|---|---|---|
| Dietary addition of extra virgin olive oil | Experimental | Dietary Supplement: Extra Virgin Olive Oil AdditionWHO diet with a daily addition of extra virgin olive oil |
| No addition of extra virgin Olive Oil | No intervention | –WHO diet |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- GDM (diagnosis criteria of the Latin American Society of Diabetes (ALAD) and Argentine Society of Diabetes (SAD): Fasting plasma glucosa > 100 mg/dl, p75 oral glucose tolerance test-2 h plasma glucose > 140 mg/dl)
Key exclusion criteria (4 listed)
- Multiple pregnancy
- Pregestational diabetes (type 1 or type 2)
- Bariatric surgery
- Infectious diseases
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 |
|---|---|---|
| Extra Virgin Olive Oil AdditionDaily dietary addition of olive oil (three tablespoons) | Dietary supplement | Dietary addition of extra virgin olive oil |
Primary outcome
maternal triglyceridemia
Time frame: term pregnancy
triglycerides in mg/dl
maternal weight gain
Time frame: change from prepregnancy weight to term pregnancy weight
gestational maternal weight gain in kg
number of participants with insulin requirement
Time frame: term pregnancy
insulin use
1 secondary outcome
number of participants with diabetes at postpartum
Time frame: six weeks postpartum
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 20 Aug 2024.
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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 Extra Virgin Olive Oil Addition in people with Gestational Diabetes, run by Center for Pharmacological and Botanical Research at 1 site in Argentina.
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 4 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 20 Aug 2024. 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 Argentina. 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?
maternal triglyceridemia (time frame: term pregnancy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2024.