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Completed

NCT Number: NCT01922791

Nutrition and Pregnancy Intervention Study

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.

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Key information

Conditions

Pregnancy Adiposity Behavior Behavior, Animal Body Weight Cardiovascular Risk Factor Cognitive Developmental Disorders Diabetes Mellitus Diabetes, Gestational Digestive System Diseases Eating Behavior Endocrine System Diseases Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Mellitus Glucose Metabolism Disorders Liver Diseases Mental Disorders Metabolic Diseases Neurodevelopmental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Type2 Diabetes Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Turku University Hospital, Turku, Finland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant, less than 17 gestational weeks
  • overweight
  • healthy

Exclusion criteria

  • Diabetes (type 1 or 2)
  • Coeliac disease
  • Increased bleeding tendency

Treatment and study plan

Comparison of probiotics, fish oil and their combination to placebo

Dietary Supplement

Double-blind randomized placebo controlled intervention

Other names: Lactobacillus and Bifidobacterium, Fish oil, Placebo, microcrystalline cellulose, Placebo, medium-chain triglycerides

Primary outcomes

  1. Prevalence of gestational diabetes mellitus, GDM

    Time frame: Assessed at gestational weeks 24-28

  2. Fasting glucose levels

    Time frame: assessed at the third trimester of pregnancy

  3. Prevalence of allergy in child

    Time frame: assessed at 12 and 24 months of age

Secondary outcomes

  1. Need for medication for management of gestational diabetes mellitus GDM (insulin or metformin)

    Time frame: During pregnancy

  2. Body composition of mother

    Time frame: During and after pregnancy

  3. Immunologic and metabolic markers

    Time frame: During and after pregnancy

  4. Fecal microbiota

    Time frame: Before, during and after intervention

  5. Fasting serum glucose (mmol/l) (mother/ child)

    Time frame: Assessed at 5-6 years postpartum

  6. Fasting serum insulin (mU/l) (mother/child)

    Time frame: Assessed at 5-6 years postpartum

  7. Number of women with prediabetes using criteria defined by American Diabetes Association

    Time frame: Assessed at 5-6 years postpartum

  8. Number of women with metabolic syndrome using criteria defined by The International Diabetes Federation

    Time frame: Assessed at 5-6 yrs postpartum

  9. Risk for Type 2 diabetes using questionnaire (mother)

    Time frame: Assessed at 5-6 yrs postpartum

  10. Serum high sensitive C-reactive protein (mg/l) (mother/child)

    Time frame: Assessed at 5-6 yrs postpartum

  11. Lipid metabolism (fasting cholesterol (mmol/l), fasting triglycerides (mmol/l), fasting HDL-cholesterol (mmol/l), fasting LDL-cholesterol (mmol/l) (mother/child)

    Time frame: Assessed at 5-6 yrs postpartum

  12. Serum metabolomics by NMR (mother/child)

    Time frame: assessed at 5-6 yrs postpartum

  13. Obesity by body mass index (mother/child) and body fat percentage by air displacement plethysmography (mother/child)

    Time frame: Assessed at 5-6 yrs postpartum

  14. Carotid intima media thickness by ultra sound (mother/child)

    Time frame: Assessed at 5-6 yrs postpartum

  15. Retinal microvasculature by digital retinal imaging (mother)

    Time frame: Assessed at 5-6 yrs postpartum

  16. Liver fat by ultra sound (mother)

    Time frame: Assessed at 5-6 yrs postpartum

  17. Liver health by ALAT (child/mother)

    Time frame: Assessed at 5-6 yrs postpartum

  18. Fecal microbiota composition (mother/child)

    Time frame: Assessed at 5-6 yrs postpartum

  19. Dietary intake of foods and nutrients and diet pattern calculated from food diaries, dietary quality index and food frequencies (assessed by questionnaires)/mother and child

    Time frame: Assessed at 5-6 yrs postpartum

  20. Eating behavior by Three Factor Eating Questionnaire, Neofobia and Comprehensive Feeding Practices Questionnaire, Child Feeding Questionnaire, Child Eating Behaviour Questionnaire (child)

    Time frame: Assessed at 5-6 yrs postpartum

  21. Motor development by Movement Assessment Battery for Children and by Developmental Coordination Disorder Questionnaire 2007 (DCDQ'07) (Child)

    Time frame: Assessed at 5-6 yrs postpartum

  22. Cognitive development by Cantab test and Wechsler Preschool and Primary Scale of Intelligence (child)

    Time frame: Assessed at 5-6 yrs postpartum

  23. Child effortful/emotionally-driven inhibition by the Forbidden Toy task and by Delay of gratification test (child)

    Time frame: Assessed at 5-6 yrs postpartum

  24. Social emotional assessment by Behavior Rating Inventory of Executive Functions (child)

    Time frame: Assessed at 5-6 yrs postpartum

  25. The child's social competence by Multisource Assessment of Children's Social Competence questionnaire and children's behavioral, social, and attention problems by the Child Behavior Checklist. (child)

    Time frame: Assessed at 5-6 yrs postpartum

  26. Infant temperament, Child Behavior Questionnaire (child)

    Time frame: Assessed at 5-6 yrs postpartum

  27. Child growth measured from weight (kg) and length (cm)

    Time frame: Assessed at 5-6 yrs postpartum

  28. Atopy by serum antigens and asthma by spirometry (child)

    Time frame: Assessed at 5-6 yrs postpartum

  29. Immunological cells from blood (child)

    Time frame: Assessed at 5-6 yrs postpartum

  30. Physical activity by questionnaires and activity monitor

    Time frame: Assessed at 5-6 yrs postpartum

Other outcomes

  1. Body composition, growth, development and metabolic markers of the child

    Time frame: 0 to 24 months of age

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • University of Turku

Registry information

Official study title

Placebo-controlled Intervention Study for Maternal and Child Health

Important dates

Study start
2013
Primary completion
2017
Study completion
2023
First posted
Aug 14, 2013
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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