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Nutrition and Pregnancy Intervention Study

NCT01922791 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 439

Last updated 2023-04-13

No results posted yet for this study

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

DIETARY_SUPPLEMENT

Comparison of probiotics, fish oil and their combination to placebo

Double-blind randomized placebo controlled intervention

Sponsors & Collaborators

  • University of Turku

    collaborator OTHER

  • Turku University Hospital

    lead OTHER_GOV

Principal Investigators

  • Kirsi Laitinen · University of Turku

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-12-31
Completion
2023-03-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01922791 on ClinicalTrials.gov