AllergiesPREMEDINCT05119868
Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring
A study testing Nutritional intervention based on Mediterranean Diet in people with Allergies and Obesity, run by Federico II University at 2 sites in Italy.
Trial summary
Allergy prevalence is increasing steadily with some describing as the "epidemic of the twenty-first century". Maternal diet during pregnancy has been linked to offspring allergy risk, so it represents a potential target for allergy prevention. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Allergies, Obesity, Gestational Complications
- What is being tested?
- Nutritional intervention based on Mediterranean Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 2 sitesItaly
- Study dates
- 2 Nov 2021to 10 Mar 2026
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy women (aged 20-35 years), at first trimester of pregnancy, of at risk for atopy baby
Who cannot join
- concomitant presence of infections;
- concomitant presence of malignancies;
- concomitant presence of major gastrointestinal malformations;
- concomitant presence of immunodeficiencies;
- concomitant presence of autoimmune diseases;
- concomitant presence of chronic inflammatory bowel diseases;
Show all 15Show fewer
- concomitant presence of functional gastrointestinal disorders;
- concomitant presence of celiac disease;
- history of abdominal surgery with gastrointestinal resection;
- concomitant presence of neuropsychiatric disorders;
- concomitant presence of central nervous system disorders;
- vegan diet;
- twin pregnancy;
- concomitant presence of genetic disorders;
- concomitant presence of metabolic disorders.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Department of Traslational Medical Science
Naples, Italy, 80131
Department of Traslational Medical Science - University of Naples Federico II
Naples, Naples, 80131
About this study
Official title: Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring: a Multi-center Randomised-controlled Trial (the PREMEDI Project)
Allergy prevalence is increasing steadily with some describing as the "epidemic of the twenty-first century". Maternal diet during pregnancy has been linked to offspring allergy risk, so it represents a potential target for allergy prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models which exerts regulatory effects on immune system, due to the synergistic and interactive combinations of nutrients. We aim to study the effects of MD in pregnancy on the onset of allergic diseases at 2 years of age in the offspring.
- Conditions
- Allergies, Obesity, Gestational Complications, Gestational Weight Gain, Perinatal Condition, Birth Weight
- Being tested
- Nutritional intervention based on Mediterranean Diet
- Medical subject headings
- Hypersensitivity, Obesity, Gestational Weight Gain, Birth Weight, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional intervention based on Mediterranean DietOther
A personalized nutritional counseling and a tailored diet, according to Mediterranean dietary pattern, designed on the pre-pregnancy weight, height and trimester of pregnancy provided by certified dietitians.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 will receive standard obstetrical and gynecological follow-up and nutritional intervention based on Mediterranean Diet provided by certified dietitians Receives: Other: Nutritional intervention based on Mediterranean Diet |
| Group 2 | No intervention | Group 2 will receive standard obstetrical and gynecological follow-up alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of allergic disorders at 24 months of age in the offspring
The evaluation of the effect of Mediterranean Diet during pregnancy on the occurrence of allergic disorders at 24 months of age in the offspring
Measured: 24 months from birth
Secondary outcomes (15)
Maternal weight gain
The evaluation of the effect of Mediterranean Diet during pregnancy on maternal weight gain
Measured: From enrollment until delivery
Pregnancy complications occurrence
The evaluation of the effect of Mediterranean Diet during pregnancy on pregnancy complications occurrence
Measured: From enrollment until delivery
Perinatal complications occurrence
The evaluation of the effect of Mediterranean Diet during pregnancy on perinatal complications occurrence
Measured: Delivery
Neonatal birth weight
The evaluation of the effect of Mediterranean Diet during pregnancy on neonatal growth indices
Measured: Delivery
Body growth in the offspring
The evaluation of the effect of Mediterranean Diet during pregnancy on body growth in the offspring
Measured: During the 24 months of life
Occurrence of any other chronic disorders in the first 2 years of age in the offspring
The evaluation of the effect of Mediterranean Diet during pregnancy on the occurrence of any other chronic disorders in the first 2 years of age in the offspring
Measured: During the 24 months of life
Mother's gut microbiome metagenomic features
The evaluation of the effect of Mediterranean Diet during pregnancy on the mother's gut microbiome metagenomic features
Measured: From enrollment until delivery
Mother's gut microbiome metabolomic features
The evaluation of the effect of Mediterranean Diet during pregnancy on the mother's gut microbiome metabolomic features
Measured: From enrollment until delivery
Son's gut microbiome metagenomic features
The evaluation of the effect of Mediterranean Diet during pregnancy on the son's gut microbiome metagenomic features
Measured: During the 24 months of life
Son's gut microbiome metabolomic features
The evaluation of the effect of Mediterranean Diet during pregnancy on the son's gut microbiome metabolomic features
Measured: During the 24 months of life
Breastfeeding duration
The evaluation of the effect of Mediterranean Diet during pregnancy on the breastfeeding duration
Measured: During the 24 months of life
Breast milk composition
The evaluation of the effect of Mediterranean Diet during pregnancy on the breast milk composition
Measured: During the 24 months of life
Epigenetic modulation of genes involved in the regulation of immune system in the offspring
The evaluation of the effect of Mediterranean Diet during pregnancy on the epigenetic modulation of genes involved in the regulation of immune system in the offspring
Measured: Delivery
Epigenetic modulation of genes involved in the metabolic pathways in the offspring
The evaluation of the effect of Mediterranean Diet during pregnancy on the epigenetic modulation of genes involved in the metabolic pathways in the offspring
Measured: Delivery
To validate a digital app
Validate an app designed to promote a healthy lifestyle and prevent the most common non-communicable chronic diseases
Measured: During the first 1000 days
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 start2 Nov 2021
- Primary completion10 Jan 2025
- Study completion10 Mar 2026
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 AllergiesStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
- Investigators
- Roberto Berni Canani, Principal investigator, Department of Traslational Medical Science at University of Naples Federico II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119868
- Sponsor's protocol ID
- 283/21
- Acronym
- PREMEDI
- Status last verified
- Jun 2026
- First submitted
- 3 Nov 2021
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coppola S, Paparo L, Chiariotti L, Ercolini D, Nocerino R, de Giovanni di Santa Severina AF, Carucci L, De Filippis F, Agangi A, Napolitano M, Passariello A, Messina F, Berni Canani R. Effects of the Mediterranean Diet during pregnancy on the onset of allergy in at risk children: A study protocol of a multi-center, randomized- controlled, parallel groups, prospective trial (the PREMEDI study). Front Nutr. 2022 Oct 13;9:951223. doi: 10.3389/fnut.2022.951223. eCollection 2022.
PubMed 36313083
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring: a Multi-center Randomised-controlled Trial (the PREMEDI Project)
- ClinicalTrials.gov ID
- NCT05119868
- Acronym / sponsor ID
- PREMEDI / 283/21
- Conditions
- Allergies, Obesity, Gestational Complications, Gestational Weight Gain, Perinatal Condition, Birth Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Mar 2026 (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.
Allergy prevalence is increasing steadily with some describing as the "epidemic of the twenty-first century". Maternal diet during pregnancy has been linked to offspring allergy risk, so it represents a potential target for allergy prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models which exerts regulatory effects on immune system, due to the synergistic and interactive combinations of nutrients. We aim to study the effects of MD in pregnancy on the onset of allergic diseases at 2 years of age in the offspring.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Nutritional intervention based on Mediterranean DietGroup 1 will receive standard obstetrical and gynecological follow-up and nutritional intervention based on Mediterranean Diet provided by certified dietitians |
| Group 2 | No intervention | –Group 2 will receive standard obstetrical and gynecological follow-up alone |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy women (aged 20-35 years), at first trimester of pregnancy, of at risk for atopy baby
Key exclusion criteria (15 listed)
- concomitant presence of infections;
- concomitant presence of malignancies;
- concomitant presence of major gastrointestinal malformations;
- concomitant presence of immunodeficiencies;
- concomitant presence of autoimmune 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 |
|---|---|---|
| Nutritional intervention based on Mediterranean DietA personalized nutritional counseling and a tailored diet, according to Mediterranean dietary pattern, designed on the pre-pregnancy weight, height and trimester of pregnancy provided by certified dietitians. | Other | Group 1 |
Primary outcome
Occurrence of allergic disorders at 24 months of age in the offspring
Time frame: 24 months from birth
The evaluation of the effect of Mediterranean Diet during pregnancy on the occurrence of allergic disorders at 24 months of age in the offspring
15 secondary outcomes
Maternal weight gain
Time frame: From enrollment until delivery
Pregnancy complications occurrence
Time frame: From enrollment until delivery
Perinatal complications occurrence
Time frame: Delivery
Neonatal birth weight
Time frame: Delivery
Body growth in the offspring
Time frame: During the 24 months of life
Occurrence of any other chronic disorders in the first 2 years of age in the offspring
Time frame: During the 24 months of life
Mother's gut microbiome metagenomic features
Time frame: From enrollment until delivery
Mother's gut microbiome metabolomic features
Time frame: From enrollment until delivery
Son's gut microbiome metagenomic features
Time frame: During the 24 months of life
Son's gut microbiome metabolomic features
Time frame: During the 24 months of life
Breastfeeding duration
Time frame: During the 24 months of life
Breast milk composition
Time frame: During the 24 months of life
Epigenetic modulation of genes involved in the regulation of immune system in the offspring
Time frame: Delivery
Epigenetic modulation of genes involved in the metabolic pathways in the offspring
Time frame: Delivery
To validate a digital app
Time frame: During the first 1000 days
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 1 Sep 2026.
- Derived from this study: PubMed 36313083Coppola S, Paparo L, Chiariotti L, Ercolini D, Nocerino R, de Giovanni di Santa Severina AF, Carucci L, De Filippis F, Agangi A, Napolitano M, Passariello A, Messina F, Berni Canani R. Effects of the Mediterranean Diet during pregnancy on the onset of allergy in at risk children: A study protocol of a multi-center, randomized- controlled, parallel groups, prospective trial (the PREMEDI study). Front Nutr. 2022 Oct 13;9:951223. doi: 10.3389/fnut.2022.951223. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Allergies
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Roberto Berni Canani principal investigator
Department of Traslational Medical Science at University of Naples Federico II
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional intervention based on Mediterranean Diet in people with Allergies and Obesity, run by Federico II University at 2 sites 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 1 inclusion and 15 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Occurrence of allergic disorders at 24 months of age in the offspring (time frame: 24 months from birth). 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 NCT05119868, 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 1 Sep 2026.