Nutrition and Pregnancy Intervention Study

Study Overview
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Brief Summary
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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.

Official Title
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Placebo-controlled Intervention Study for Maternal and Child Health

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

Intervention / Treatment
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* Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant, less than 17 gestational weeks overweight healthy Exclusion Criteria: Diabetes (type 1 or 2) Coeliac disease Increased bleeding tendency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic<br>Comparison of probiotics, fish oil and their combination to placebo | Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo<br>* Double-blind randomized placebo controlled intervention<br>* Other names: Placebo, medium-chain triglycerides;|
| Active Comparator: Fish oil<br>Comparison of probiotics, fish oil and their combination to placebo | Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo<br>* Double-blind randomized placebo controlled intervention<br>* Other names: Placebo, medium-chain triglycerides;|
| Active Comparator: Probiotics and Fish oil<br>Comparison of probiotics, fish oil and their combination to placebo | Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo<br>* Double-blind randomized placebo controlled intervention<br>* Other names: Placebo, medium-chain triglycerides;|
| Placebo Comparator: Placebo<br>Comparison of probiotics, fish oil and their combination to placebo | Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo<br>* Double-blind randomized placebo controlled intervention<br>* Other names: Placebo, medium-chain triglycerides;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of gestational diabetes mellitus, GDM |  | Assessed at gestational weeks 24-28 | 
| Fasting glucose levels |  | assessed at the third trimester of pregnancy | 
| Prevalence of allergy in child |  | assessed at 12 and 24 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for medication for management of gestational diabetes mellitus GDM (insulin or metformin) |  | During pregnancy | 
| Body composition of mother |  | During and after pregnancy | 
| Immunologic and metabolic markers |  | During and after pregnancy | 
| Fecal microbiota |  | Before, during and after intervention | 
| Fasting serum glucose (mmol/l) (mother/ child) |  | Assessed at 5-6 years postpartum | 
| Fasting serum insulin (mU/l) (mother/child) |  | Assessed at 5-6 years postpartum | 
| Number of women with prediabetes using criteria defined by American Diabetes Association |  | Assessed at 5-6 years postpartum | 
| Number of women with metabolic syndrome using criteria defined by The International Diabetes Federation |  | Assessed at 5-6 yrs postpartum | 
| Risk for Type 2 diabetes using questionnaire (mother) |  | Assessed at 5-6 yrs postpartum | 
| Serum high sensitive C-reactive protein (mg/l) (mother/child) |  | 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) |  | Assessed at 5-6 yrs postpartum | 
| Serum metabolomics by NMR (mother/child) |  | assessed at 5-6 yrs postpartum | 
| Obesity by body mass index (mother/child) and body fat percentage by air displacement plethysmography (mother/child) |  | Assessed at 5-6 yrs postpartum | 
| Carotid intima media thickness by ultra sound (mother/child) |  | Assessed at 5-6 yrs postpartum | 
| Retinal microvasculature by digital retinal imaging (mother) |  | Assessed at 5-6 yrs postpartum | 
| Liver fat by ultra sound (mother) |  | Assessed at 5-6 yrs postpartum | 
| Liver health by ALAT (child/mother) |  | Assessed at 5-6 yrs postpartum | 
| Fecal microbiota composition (mother/child) |  | 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 |  | 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) |  | Assessed at 5-6 yrs postpartum | 
| Motor development by Movement Assessment Battery for Children and by Developmental Coordination Disorder Questionnaire 2007 (DCDQ'07) (Child) |  | Assessed at 5-6 yrs postpartum | 
| Cognitive development by Cantab test and Wechsler Preschool and Primary Scale of Intelligence (child) |  | Assessed at 5-6 yrs postpartum | 
| Child effortful/emotionally-driven inhibition by the Forbidden Toy task and by Delay of gratification test (child) |  | Assessed at 5-6 yrs postpartum | 
| Social emotional assessment by Behavior Rating Inventory of Executive Functions (child) |  | 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) |  | Assessed at 5-6 yrs postpartum | 
| Infant temperament, Child Behavior Questionnaire (child) |  | Assessed at 5-6 yrs postpartum | 
| Child growth measured from weight (kg) and length (cm) |  | Assessed at 5-6 yrs postpartum | 
| Atopy by serum antigens and asthma by spirometry (child) |  | Assessed at 5-6 yrs postpartum | 
| Immunological cells from blood (child) |  | Assessed at 5-6 yrs postpartum | 
| Physical activity by questionnaires and activity monitor |  | Assessed at 5-6 yrs postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Probiotics, Fish oil