Effect of Mediterranean Diet During Pregnancy on the Onset of Overweight and Obesity in the Offspring

NCT ID: NCT03337802

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2021-01-31

Brief 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. 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.

Conditions

Food Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Pregnant women at standard diet

obstetrical and gynecological follow-up

Group Type: NO_INTERVENTION

No interventions assigned to this group

Pregnant women at mediterranean diet

obstetrical and gynecological follow-up + nutritional counseling

Group Type: EXPERIMENTAL

mediterranean diet

Intervention Type: BEHAVIORAL

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.

Interventions

mediterranean diet

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• women
• caucasian ethnicity
• aged between 20 and 35 years

Exclusion Criteria

• 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,
• chronic intestinal inflammatory diseases,
• gastrointestinal function disorders,
• celiac disease;
• history of abdominal surgery with intestinal resection,
• neuropsychiatric disorders,
• central nervous system disorders,
• vegan diet.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Roberto Berni Canani, MD, PhD

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Berni Canani

Role: PRINCIPAL_INVESTIGATOR

Department of Traslational Medical Science, University of Naples Federico II

Locations

University of Naples Federico II

Naples, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 39289583 (View on PubMed)

Other Identifiers

298/16

Identifier Type: -

Identifier Source: org_study_id