NCT01922791

Nutrition and Pregnancy Intervention Study

Placebo-controlled Intervention Study for Maternal and Child Health

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 439 (actual)
• Sponsor: Turku University Hospital · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A randomized double-blind placebo controlled intervention study with pregnant obese women (n=440) will be conducted. The intervention will involve consumption of fish oil and/or probiotic capsules from early pregnancy until 6 months after delivery. The aim of the study is firstly to investigate the effects of the supplements on the risk of gestational diabetes mellitus and obesity in the women and secondly to modify the risk markers of allergy and obesity in children of the women. Also the underlying metabolic mechanisms will be investigated. Follow up visits at child's age of 5 to 6 years will be conducted to evalute long-term effects on maternal and child health. The aim is to investigate the impact of dietary intervention, diet, maternal overweight/obesity and gestational diabetes status as well as gut microbiota and metabolism during pregnancy on maternal and child's health, allergy and child neuropsychological development.

Conditions

• Pregnancy
• Obesity
• Gestational Diabetes Mellitus
• Adiposity
• Type2 Diabetes
• Cardiovascular Risk Factor
• Eating Behavior
• Liver Diseases
• Neurodevelopmental Disorders
• Cognitive Developmental Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Comparison of probiotics, fish oil and their combination to placebo	Double-blind randomized placebo controlled intervention

Timeline

• Start date: 2013-10-01
• Primary completion: 2017-12-01
• Completion: 2023-03-01
• First posted: 2013-08-14
• Last updated: 2023-04-13

Locations

2 sites across 1 country: Finland