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

NCT03337802 | Completed

• 1 other identifier: 298/16
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  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.

  after 9 months (at the end of the pregnancy)

• The adherence to Mediterranean Diet in the enrolled women

  from 0 to 9 months (at the end of pregnancy)

• The effect of dietary counseling on dietary habits

  from 0 to 9 months (at the end of pregnancy)

• The effect of Mediterranean diet in pregnancy on the maternal weight gain and complications

  from 0 to 9 months (at the end of pregnancy)

Study Arms (2)

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

Behavioral: mediterranean diet

Interventions

mediterranean diet 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.

Pregnant women at mediterranean diet

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

Location

Related Publications (1)

• 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.

  PMID: 39289583 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Roberto Berni Canani

  Department of Traslational Medical Science, University of Naples Federico II

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 9, 2017
• Study Start: November 30, 2017
• Primary Completion: November 30, 2020
• Study Completion: January 31, 2021
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)