Gestational DiabetesPhase 4PREDIP2NCT05393843
Prevention of Maternal and Fetal Metabolic Complications With Diet and Nutraceutical Supplementation in Pregnant Women Affected by Gestational Diabetes: a Randomized, Double-blind Placebo Controlled Trial.
A Phase 4 study testing omega-3 fatty acids, anthocyanins and alpha-cyclodextrins and diet in people with Gestational Diabetes and Oxidative Stress, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Our trial aims to assess the effect of nutraceutical supplements (omega-3 fatty acids, anthocyanins and alpha-cyclodextrins) in patients affected by gestational diabetes. Pregnant women with gestational diabetes at 24-28 weeks of gestation are enrolled in a double-blind trial and randomized to receive either… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Oxidative Stress
- What is being tested?
- omega-3 fatty acids, anthocyanins and alpha-cyclodextrins and diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2018to 1 Mar 2020
- Phase
- Phase 4
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients between 24 and 28 weeks of gestation with positive result to an Oral Glucose Tolerance Test with 75 gr glucose performed after 24 gestational weeks, according to the International Association of Diabetes and Pregnancy Study Group (IADPSG) recommendations (at least one of the following criteria: baseline glycemia ≥ 92 mg/dl, 1-h glycemia ≥ 180 mg/dl, 2-h glycemia ≥ 153 mg/dl)
- maternal age ≥ 18 years.
Who cannot join
- multiple pregnancies
- fetal malformation
- maternal diseases (type 1 and type 2 diabetes, hypothyroidism and hyperthyroidism, immunological disorders)
- abnormal blood glucose values before 24 weeks of gestation.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
About this study
Official title: Prevention of Maternal and Fetal Metabolic Complications With Polyphenols and Omega-3 Fatty Acids Supplementation in Pregnant Women Affected by Gestational Diabetes on Diet Therapy: a Randomized, Double-blind Placebo Controlled Trial.
Our trial aims to assess the effect of nutraceutical supplements (omega-3 fatty acids, anthocyanins and alpha-cyclodextrins) in patients affected by gestational diabetes.
Pregnant women with gestational diabetes at 24-28 weeks of gestation are enrolled in a double-blind trial and randomized to receive either nutraceutical supplements or a placebo for 12 weeks.
Read the detailed description
Randomized, Double-blind trial Aims: evaluation of the metabolic effect on patients affected by gestational diabetes of anti-inflammatory, anti-oxidant nutraceutical supplementation with omega-3 fatty acids, anthocyanins and alpha-cyclodextrins for 12 weeks associated with appropriate nutritional coaching versus nutritional coaching and placebo.
All women receive a personalized diet by a nutrition expert educator and should monitor capillary blood glucose levels. Patients receive twice-weekly antenatal testing, including ultrasonography for fetal growth and well-being maternal weight body fat mass distribution evaluation using skinfold caliper, dietary counselling. Blood and urine samples are drawn from all patients at recruitment and at the last study visit.
- Conditions
- Gestational Diabetes, Oxidative Stress
- Being tested
- omega-3 fatty acids, anthocyanins and alpha-cyclodextrins, diet, placebo
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 fatty acids, anthocyanins and alpha-cyclodextrinsDietary supplement
administration for 12 weeks
dietBehavioural
12 weeks of personalized diet according to the Mediterranean standard diet referrals, the Healthy Eating Plate recommendations of Harvard University School of Public Health, and the reference intake levels of nutrients and energy for the Italian population (LARN) for pregnant women
placeboOther
sunflower oil as placebo for Omega3 fatty acids; isomaltulosio as placebo for Anthocyanins and Alpha-cyclodextrins; administration for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| intervention | Active comparator | patients receiving
* diet
* Omega-3 fatty acids (EnerZona Omega3Rx®, Enervit, Italia), at a daily dosage of 2.4 gr at breakfast.
* Anthocyanins (EnerZona Maqui Response Buste®, Enervit, Italia) at a total daily dosage of 108 mg divided into three equal intakes at breakfast, lunch and dinner.
* Alpha-cyclodextrins (EnerZona Maqui Response Buste®, Enervit, Italia) at a total daily dosage of 15 gr divided into three equal intakes at breakfast, lunch and din-ner Receives: Dietary Supplement: omega-3 fatty acids, anthocyanins and alpha-cyclodextrins; Behavioral: diet |
| placebo | Placebo comparator | patients receiving
* diet
* placebo (sunflower oil as placebo for Omega3 fatty acids; isomaltulosio as placebo for Anthocyanins and Alpha-cyclodextrins) Receives: Behavioral: diet; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
capillary blood glucose level
percentage of patients with median capillary blood glucose values 10 mg/dl below the target (if the fetal abdominal circunference is below 75° percentile according to gestational age: basal level 95 mg/dl, 2-h post prandial level 120 mg/dl; if the fetal abdominal circunference is above 75° percentile according to gestational age: basal level 90 mg/dl, 2-h post prandial level 110 mg/dl;
Measured: 12 weeks
plasmatic glycated haemoglobin
change in plasmatic glycated haemoglobin
Measured: 12 weeks
Secondary outcomes (1)
therapy for diabetes
percentage of patients requiring pharmacological treatment for gestational diabetes such as insulin or methformin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 May 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Why it stopped: outbreak of covid pandemic that caused problems with nutritional coaching in person.
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.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrico Ferrazzi, Professor, Study director, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393843
- Sponsor's protocol ID
- PRE.D.I.P.2
- Acronym
- PREDIP2
- Status last verified
- Mar 2018
- First submitted
- 18 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Maternal and Fetal Metabolic Complications With Polyphenols and Omega-3 Fatty Acids Supplementation in Pregnant Women Affected by Gestational Diabetes on Diet Therapy: a Randomized, Double-blind Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT05393843
- Acronym / sponsor ID
- PREDIP2 / PRE.D.I.P.2
- Conditions
- Gestational Diabetes, Oxidative Stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: outbreak of covid pandemic that caused problems with nutritional coaching in person.
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 26 May 2022 (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.
Our trial aims to assess the effect of nutraceutical supplements (omega-3 fatty acids, anthocyanins and alpha-cyclodextrins) in patients affected by gestational diabetes.
Pregnant women with gestational diabetes at 24-28 weeks of gestation are enrolled in a double-blind trial and randomized to receive either nutraceutical supplements or a placebo for 12 weeks.
Detailed description
Randomized, Double-blind trial Aims: evaluation of the metabolic effect on patients affected by gestational diabetes of anti-inflammatory, anti-oxidant nutraceutical supplementation with omega-3 fatty acids, anthocyanins and alpha-cyclodextrins for 12 weeks associated with appropriate nutritional coaching versus nutritional coaching and placebo.
All women receive a personalized diet by a nutrition expert educator and should monitor capillary blood glucose levels. Patients receive twice-weekly antenatal testing, including ultrasonography for fetal growth and well-being maternal weight body fat mass distribution evaluation using skinfold caliper, dietary counselling. Blood and urine samples are drawn from all patients at recruitment and at the last study visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double-blind
| Arm | Type | Receives |
|---|---|---|
| intervention | Active comparator | Dietary Supplement: omega-3 fatty acids, anthocyanins and alpha-cyclodextrins, Behavioral: dietpatients receiving * diet * Omega-3 fatty acids (EnerZona Omega3Rx®, Enervit, Italia), at a daily dosage of 2.4 gr at breakfast. * Anthocyanins (EnerZona Maqui Response Buste®, Enervit, Italia) at a total daily dosage of 108 mg divided into three equal intakes at breakfast, lunch and dinner. * Alpha-cyclodextrins (EnerZona Maqui Response Buste®, Enervit, Italia) at a total daily dosage of 15 gr divided into three equal intakes at breakfast, lunch and din-ner |
| placebo | Placebo comparator | Behavioral: diet, Other: placebopatients receiving * diet * placebo (sunflower oil as placebo for Omega3 fatty acids; isomaltulosio as placebo for Anthocyanins and Alpha-cyclodextrins) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients between 24 and 28 weeks of gestation with positive result to an Oral Glucose Tolerance Test with 75 gr glucose performed after 24 gestational weeks, according to the International Association of Diabetes and Pregnancy Study Group (IADPSG) recommendations (at least one of the following criteria: baseline glycemia ≥ 92 mg/dl, 1-h glycemia ≥ 180 mg/dl, 2-h glycemia ≥ 153 mg/dl)
- maternal age ≥ 18 years.
Key exclusion criteria (4 listed)
- multiple pregnancies
- fetal malformation
- maternal diseases (type 1 and type 2 diabetes, hypothyroidism and hyperthyroidism, immunological disorders)
- abnormal blood glucose values before 24 weeks of gestation.
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 |
|---|---|---|
| omega-3 fatty acids, anthocyanins and alpha-cyclodextrinsadministration for 12 weeks | Dietary supplement | intervention |
| diet12 weeks of personalized diet according to the Mediterranean standard diet referrals, the Healthy Eating Plate recommendations of Harvard University School of Public Health, and the reference intake levels of nutrients and energy for the Italian population (LARN) for pregnant women | Behavioural | intervention, placebo |
| placebosunflower oil as placebo for Omega3 fatty acids; isomaltulosio as placebo for Anthocyanins and Alpha-cyclodextrins; administration for 12 weeks | Other | placebo |
Primary outcome
capillary blood glucose level
Time frame: 12 weeks
percentage of patients with median capillary blood glucose values 10 mg/dl below the target (if the fetal abdominal circunference is below 75° percentile according to gestational age: basal level 95 mg/dl, 2-h post prandial level 120 mg/dl; if the fetal abdominal circunference is above 75° percentile according to gestational age: basal level 90 mg/dl, 2-h post prandial level 110 mg/dl;
plasmatic glycated haemoglobin
Time frame: 12 weeks
change in plasmatic glycated haemoglobin
1 secondary outcome
therapy for diabetes
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: outbreak of covid pandemic that caused problems with nutritional coaching in person.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: No
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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.
Enrico Ferrazzi, Professor study director
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing omega-3 fatty acids, anthocyanins and alpha-cyclodextrins and diet in people with Gestational Diabetes and Oxidative Stress, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 2 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: stopped early, as of the sponsor's last update on 26 May 2022. 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 Italy. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: outbreak of covid pandemic that caused problems with nutritional coaching in person.). Results are not available in the source record.
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?
capillary blood glucose level (time frame: 12 weeks). The study lists 2 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 26 May 2022.