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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
439
Double-blind randomized placebo controlled intervention
University of Turku
Turku, Finland
Turku University Hospital
Turku, Finland
Prevalence of gestational diabetes mellitus, GDM
Time frame: Assessed at gestational weeks 24-28
Fasting glucose levels
Time frame: assessed at the third trimester of pregnancy
Prevalence of allergy in child
Time frame: assessed at 12 and 24 months of age
Need for medication for management of gestational diabetes mellitus GDM (insulin or metformin)
Time frame: During pregnancy
Body composition of mother
Time frame: During and after pregnancy
Immunologic and metabolic markers
Time frame: During and after pregnancy
Fecal microbiota
Time frame: Before, during and after intervention
Fasting serum glucose (mmol/l) (mother/ child)
Time frame: Assessed at 5-6 years postpartum
Fasting serum insulin (mU/l) (mother/child)
Time frame: Assessed at 5-6 years postpartum
Number of women with prediabetes using criteria defined by American Diabetes Association
Time frame: Assessed at 5-6 years postpartum
Number of women with metabolic syndrome using criteria defined by The International Diabetes Federation
Time frame: Assessed at 5-6 yrs postpartum
Risk for Type 2 diabetes using questionnaire (mother)
Time frame: Assessed at 5-6 yrs postpartum
Serum high sensitive C-reactive protein (mg/l) (mother/child)
Time frame: Assessed at 5-6 yrs postpartum
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
Serum metabolomics by NMR (mother/child)
Time frame: assessed at 5-6 yrs postpartum
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
Carotid intima media thickness by ultra sound (mother/child)
Time frame: Assessed at 5-6 yrs postpartum
Retinal microvasculature by digital retinal imaging (mother)
Time frame: Assessed at 5-6 yrs postpartum
Liver fat by ultra sound (mother)
Time frame: Assessed at 5-6 yrs postpartum
Liver health by ALAT (child/mother)
Time frame: Assessed at 5-6 yrs postpartum
Fecal microbiota composition (mother/child)
Time frame: Assessed at 5-6 yrs postpartum
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
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
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
Cognitive development by Cantab test and Wechsler Preschool and Primary Scale of Intelligence (child)
Time frame: Assessed at 5-6 yrs postpartum
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
Social emotional assessment by Behavior Rating Inventory of Executive Functions (child)
Time frame: Assessed at 5-6 yrs postpartum
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
Infant temperament, Child Behavior Questionnaire (child)
Time frame: Assessed at 5-6 yrs postpartum
Child growth measured from weight (kg) and length (cm)
Time frame: Assessed at 5-6 yrs postpartum
Atopy by serum antigens and asthma by spirometry (child)
Time frame: Assessed at 5-6 yrs postpartum
Immunological cells from blood (child)
Time frame: Assessed at 5-6 yrs postpartum
Physical activity by questionnaires and activity monitor
Time frame: Assessed at 5-6 yrs postpartum
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