Food AllergyPREMEDINCT03337802
Effect of Mediterranean Diet During Pregnancy on the Onset of Overweight and Obesity in the Offspring
A study testing mediterranean diet in people with Food Allergy, run by Federico II University at 1 site in Italy.
Trial summary
The first 1,000 days of life, from the conception to 24 months, are crucial to achieve long-term health outcomes and represent a strategic period to intervene under prevention and public health perspective. Nutritional exposures during this critical period of life can influence the future disease susceptibility. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Food Allergy
- What is being tested?
- mediterranean diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 30 Nov 2017to 31 Jan 2021
- 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
- No healthy volunteers
- Adult
Who may be able to join
- women
- caucasian ethnicity
- aged between 20 and 35 years
Who cannot join
- proven presence of infections during pregnancy and at delivery,
- twin pregnancy,
- ongoing malignancies,
- major gastrointestinal tract malformations,
- immunodeficiencies,
- diabetes and other chronic diseases at each organ or apparatus level,
Show all 13Show fewer
- chronic intestinal inflammatory diseases,
- gastrointestinal function disorders,
- celiac disease;
- history of abdominal surgery with intestinal resection,
- neuropsychiatric disorders,
- central nervous system disorders,
- vegan diet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mediterranean Diet During Pregnancy on the Onset of Overweight and Obesity at 24 Months in the Offspring
The first 1,000 days of life, from the conception to 24 months, are crucial to achieve long-term health outcomes and represent a strategic period to intervene under prevention and public health perspective. Nutritional exposures during this critical period of life can influence the future disease susceptibility. Maternal diet during pregnancy has been linked to offspring overweight/obesity risk and it could represent a potential target for overweight/obesity prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models, which impacts beneficially the gut microbiome (GM), providing high amounts of fiber, antioxidants polyphenols and vitamins, and a balanced ratio of essential fatty acids (ω6:ω3). Notably, the MD beneficial effects are due to the synergistic and interactive combinations of nutrients, and the modulation of gene expression through epigenetic changes. Unofrtunately, the MD mechanisms during pregnancy in the prevention of childhood overweight/obesity are not yet fully known.
Read the detailed description
The PREMEDI study has been designed to evaluate the effects of Mediterranean Diet during pregnancy on the occurrence of overweight/obesity at 24 months in the offspring.
- Conditions
- Food Allergy
- Being tested
- mediterranean diet
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mediterranean dietBehavioural
The Mediterranean diet (MD) is highly regarded as a healthy balanced diet. It is distinguished by a beneficial fatty acid profile that is rich in both monounsaturated and polyunsaturated fatty acids, high levels of polyphenols and other antioxidants, high intake of fiber and other low glycemic carbohydrates, and relatively greater vegetable than animal protein intake. Specifically, olive oil, assorted fruits, vegetables, cereals, legumes, and nuts; moderate consumption of fish, poultry, and red wine; and a lower intake of dairy products, red meat, processed meat and sweets characterize the traditional MD.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women at standard diet | No intervention | obstetrical and gynecological follow-up |
| Pregnant women at mediterranean diet | Experimental | obstetrical and gynecological follow-up + nutritional counseling Receives: Behavioral: mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of Mediterranean Diet in pregnancy on the occurrence of overweight/obesity at 24 months in the offspring
The children body growth indices are evaluated at 24 months
Measured: After 24 months from the delivery
Secondary outcomes (9)
The effect of Mediterranean Diet pregnancy on the composition of maternal gut microbiota through analysis of gut microbiota composition.
Fecal bacteria DNA will be extracted using standard technique outlined by the Earth Microbiome Project. 16S V4-region amplicon libraries will be produced using previously described primers and sequenced using the IlluminaMiSeqplatform (150bpx2). Bacterial load will be determined by qPCR using a standard curve derived from a plasmid containing a single copy of the 16S rRNAencoding gene. Sequence data has been deposited in MG RAST under accession numbers 4571868.3-4571924.3 and project number 10023. Paired end reads will be quality trimmed and processed for OTU (operational taxonomic unit) clustering using UPARSE pipeline, set at 0.97% identity cutoff. Taxonomic status will be assigned to the high quality (<1% incorrect bases) candidate OTUs using the "parallel_assign_taxonomy_rdp.py" script of QIIME software. Multiple sequence alignment and phylogenetic reconstruction will be performed using PyNast and FastTree.
Measured: after 9 months (at the end of the pregnancy)
The effect of Mediterranean diet in pregnancy on the production of short chain fatty acids (butyrate and propionate) in the intestinal tract.
Fecal SCFAs concentration Frozen feces weighing 1g will be diluted with saline solution, vortexed, and centrifuged. Supernatants will be filtered and stored at -20°C until analysis. Frozen fecal extracts will be acidified and extracted in duplicate. A quantity of the pooled extract containing acidified butyrate, propionate or acetate will be transferred into a 2ml glass vial and loaded onto an Agilent Technologies 7890 gas chromatograph (GC) system. Detection will be achieved using a flame ionization detector. Peaks will be identified using a mixed external standard and quantified by peak height/internal standard ratio. To examine whether fecal butyrate levels correlates with bacterial diversity (Shannon diversity index) and evenness (Pielou's evenness index) and abundance patterns across multiple groups we will calculate the Spearman correlation using the cor.test function implemented in R (http://www.r-project.org/
Measured: after 9 months (at the end of the pregnancy)
The adherence to Mediterranean Diet in the enrolled women
Women Mediterranean Diet adherence score is evaluated through the "Med Diet Score"
Measured: from 0 to 9 months (at the end of pregnancy)
The effect of dietary counseling on dietary habits
The diet composition in macro- and micronutrients is evaluated
Measured: from 0 to 9 months (at the end of pregnancy)
The effect of Mediterranean diet in pregnancy on the maternal weight gain and complications
To evaluate the effect of Mediterranean diet in pregnancy on the maternal weight gain and complications (gestational hypertension, infections, gestational diabetes, preeclampsia, use of cesarean)
Measured: from 0 to 9 months (at the end of pregnancy)
The effect of Mediterranean diet in pregnancy on perinatal and fetal complications
Perinatal and fetal complications occurrence are evaluated
Measured: from 0 to 9 months (at the end of pregnancy)
The effect of Mediterranean Diet in pregnancy on the duration of breastfeeding and the composition of breast milk
The effect of Mediterranean Diet in pregnancy on the duration of breastfeeding and the composition of breast milk (short chain fatty acids, bacterial DNA, adipocytokines.
Measured: from 0 to 4 months lactation
The effect of Mediterranean Diet on the occurrence of allergies and use of antibiotics in the first 2 years of life.
The occurrence of allergies and the use of antibiotics in the first 2 years of life are evaluated
Measured: Every 6 months from offspring birth to 2 years
The effect of Mediterranean Diet on the epigenetic modulation of genes involved in the regulation of immune system and metabolic pathways in the offspring
The evaluation of the effect of Mediterranean Diet during pregnancy on the epigenetic modulation of genes involved in the immune system and metabolic pathways in the offspring through the cord blood epigenome-wide association study
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start30 Nov 2017
- Primary completion30 Nov 2020
- Study completion31 Jan 2021
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 Food AllergyStudies 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
- 100 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, University of Naples Federico II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337802
- Sponsor's protocol ID
- 298/16
- Acronym
- PREMEDI
- Status last verified
- Jun 2022
- First submitted
- 2 Nov 2017
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coppola S, Paparo L, Bedogni G, Nocerino R, Costabile D, Cuomo M, Chiariotti L, Carucci L, Agangi A, Napolitano M, Messina F, Passariello A, Berni Canani R. Effects of Mediterranean diet during pregnancy on the onset of overweight or obesity in the offspring: a randomized trial. Int J Obes (Lond). 2025 Jan;49(1):101-108. doi: 10.1038/s41366-024-01626-z. Epub 2024 Sep 18.
PubMed 39289583
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mediterranean Diet During Pregnancy on the Onset of Overweight and Obesity at 24 Months in the Offspring
- ClinicalTrials.gov ID
- NCT03337802
- Acronym / sponsor ID
- PREMEDI / 298/16
- Conditions
- Food Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 9 Nov 2017 (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 first 1,000 days of life, from the conception to 24 months, are crucial to achieve long-term health outcomes and represent a strategic period to intervene under prevention and public health perspective. Nutritional exposures during this critical period of life can influence the future disease susceptibility. Maternal diet during pregnancy has been linked to offspring overweight/obesity risk and it could represent a potential target for overweight/obesity prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models, which impacts beneficially the gut microbiome (GM), providing high amounts of fiber, antioxidants polyphenols and vitamins, and a balanced ratio of essential fatty acids (ω6:ω3). Notably, the MD beneficial effects are due to the synergistic and interactive combinations of nutrients, and the modulation of gene expression through epigenetic changes. Unofrtunately, the MD mechanisms during pregnancy in the prevention of childhood overweight/obesity are not yet fully known.
Detailed description
The PREMEDI study has been designed to evaluate the effects of Mediterranean Diet during pregnancy on the occurrence of overweight/obesity at 24 months 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 |
|---|---|---|
| Pregnant women at standard diet | No intervention | –obstetrical and gynecological follow-up |
| Pregnant women at mediterranean diet | Experimental | Behavioral: mediterranean dietobstetrical and gynecological follow-up + nutritional counseling |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women
- caucasian ethnicity
- aged between 20 and 35 years
Key exclusion criteria (13 listed)
- proven presence of infections during pregnancy and at delivery,
- twin pregnancy,
- ongoing malignancies,
- major gastrointestinal tract malformations,
- immunodeficiencies,
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 |
|---|---|---|
| mediterranean dietThe Mediterranean diet (MD) is highly regarded as a healthy balanced diet. It is distinguished by a beneficial fatty acid profile that is rich in both monounsaturated and polyunsaturated fatty acids, high levels of polyphenols and other antioxidants, high intake of fiber and other low glycemic carbohydrates, and relatively greater vegetable than animal protein intake. Specifically, olive oil, assorted fruits, vegetables, cereals, legumes, and nuts; moderate consumption of fish, poultry, and red wine; and a lower intake of dairy products, red meat, processed meat and sweets characterize the traditional MD. | Behavioural | Pregnant women at mediterranean diet |
Primary outcome
The effects of Mediterranean Diet in pregnancy on the occurrence of overweight/obesity at 24 months in the offspring
Time frame: After 24 months from the delivery
The children body growth indices are evaluated at 24 months
9 secondary outcomes
The effect of Mediterranean Diet pregnancy on the composition of maternal gut microbiota through analysis of gut microbiota composition.
Time frame: after 9 months (at the end of the pregnancy)
The effect of Mediterranean diet in pregnancy on the production of short chain fatty acids (butyrate and propionate) in the intestinal tract.
Time frame: after 9 months (at the end of the pregnancy)
The adherence to Mediterranean Diet in the enrolled women
Time frame: from 0 to 9 months (at the end of pregnancy)
The effect of dietary counseling on dietary habits
Time frame: from 0 to 9 months (at the end of pregnancy)
The effect of Mediterranean diet in pregnancy on the maternal weight gain and complications
Time frame: from 0 to 9 months (at the end of pregnancy)
The effect of Mediterranean diet in pregnancy on perinatal and fetal complications
Time frame: from 0 to 9 months (at the end of pregnancy)
The effect of Mediterranean Diet in pregnancy on the duration of breastfeeding and the composition of breast milk
Time frame: from 0 to 4 months lactation
The effect of Mediterranean Diet on the occurrence of allergies and use of antibiotics in the first 2 years of life.
Time frame: Every 6 months from offspring birth to 2 years
The effect of Mediterranean Diet on the epigenetic modulation of genes involved in the regulation of immune system and metabolic pathways in the offspring
Time frame: At delivery
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 8 Jun 2022.
- Derived from this study: PubMed 39289583Coppola S, Paparo L, Bedogni G, Nocerino R, Costabile D, Cuomo M, Chiariotti L, Carucci L, Agangi A, Napolitano M, Messina F, Passariello A, Berni Canani R. Effects of Mediterranean diet during pregnancy on the onset of overweight or obesity in the offspring: a randomized trial. Int J Obes (Lond). 2025 Jan;49(1):101-108. doi: 10.1038/s41366-024-01626-z. Epub 2024 Sep 18.
- 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.
Roberto Berni Canani principal investigator
Department of Traslational Medical Science, University of Naples Federico II
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mediterranean diet in people with Food Allergy, run by Federico II University 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 3 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 8 Jun 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. 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?
The effects of Mediterranean Diet in pregnancy on the occurrence of overweight/obesity at 24 months in the offspring (time frame: After 24 months from the delivery). 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 NCT03337802, 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 8 Jun 2022.