Nutrition and Pregnancy Intervention Study
Primary Purpose
Pregnancy, Obesity, Gestational Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Comparison of probiotics, fish oil and their combination to placebo
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy focused on measuring Nutrition, Probiotics, Fish oil
Eligibility Criteria
Inclusion Criteria:
- pregnant, less than 17 gestational weeks
- overweight
- healthy
Exclusion Criteria:
- Diabetes (type 1 or 2)
- Coeliac disease
- Increased bleeding tendency
Sites / Locations
- University of Turku
- Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Probiotic
Fish oil
Probiotics and Fish oil
Placebo
Arm Description
Comparison of probiotics, fish oil and their combination to placebo
Comparison of probiotics, fish oil and their combination to placebo
Comparison of probiotics, fish oil and their combination to placebo
Comparison of probiotics, fish oil and their combination to placebo
Outcomes
Primary Outcome Measures
Prevalence of gestational diabetes mellitus, GDM
Fasting glucose levels
Prevalence of allergy in child
Secondary Outcome Measures
Need for medication for management of gestational diabetes mellitus GDM (insulin or metformin)
Body composition of mother
Immunologic and metabolic markers
Fecal microbiota
Fasting serum glucose (mmol/l) (mother/ child)
Fasting serum insulin (mU/l) (mother/child)
Number of women with prediabetes using criteria defined by American Diabetes Association
Number of women with metabolic syndrome using criteria defined by The International Diabetes Federation
Risk for Type 2 diabetes using questionnaire (mother)
Serum high sensitive C-reactive protein (mg/l) (mother/child)
Lipid metabolism (fasting cholesterol (mmol/l), fasting triglycerides (mmol/l), fasting HDL-cholesterol (mmol/l), fasting LDL-cholesterol (mmol/l) (mother/child)
Serum metabolomics by NMR (mother/child)
Obesity by body mass index (mother/child) and body fat percentage by air displacement plethysmography (mother/child)
Carotid intima media thickness by ultra sound (mother/child)
Retinal microvasculature by digital retinal imaging (mother)
Liver fat by ultra sound (mother)
Liver health by ALAT (child/mother)
Fecal microbiota composition (mother/child)
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
Eating behavior by Three Factor Eating Questionnaire, Neofobia and Comprehensive Feeding Practices Questionnaire, Child Feeding Questionnaire, Child Eating Behaviour Questionnaire (child)
Motor development by Movement Assessment Battery for Children and by Developmental Coordination Disorder Questionnaire 2007 (DCDQ'07) (Child)
Cognitive development by Cantab test and Wechsler Preschool and Primary Scale of Intelligence (child)
Child effortful/emotionally-driven inhibition by the Forbidden Toy task and by Delay of gratification test (child)
Social emotional assessment by Behavior Rating Inventory of Executive Functions (child)
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)
Infant temperament, Child Behavior Questionnaire (child)
Child growth measured from weight (kg) and length (cm)
Atopy by serum antigens and asthma by spirometry (child)
Immunological cells from blood (child)
Physical activity by questionnaires and activity monitor
Full Information
NCT ID
NCT01922791
First Posted
August 12, 2013
Last Updated
April 12, 2023
Sponsor
Turku University Hospital
Collaborators
University of Turku
1. Study Identification
Unique Protocol Identification Number
NCT01922791
Brief Title
Nutrition and Pregnancy Intervention Study
Official Title
Placebo-controlled Intervention Study for Maternal and Child Health
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
Collaborators
University of Turku
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Obesity, Gestational Diabetes Mellitus, Adiposity, Type2 Diabetes, Cardiovascular Risk Factor, Eating Behavior, Liver Diseases, Neurodevelopmental Disorders, Cognitive Developmental Disorders
Keywords
Nutrition, Probiotics, Fish oil
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
439 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
Comparison of probiotics, fish oil and their combination to placebo
Arm Title
Fish oil
Arm Type
Active Comparator
Arm Description
Comparison of probiotics, fish oil and their combination to placebo
Arm Title
Probiotics and Fish oil
Arm Type
Active Comparator
Arm Description
Comparison of probiotics, fish oil and their combination to placebo
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Comparison of probiotics, fish oil and their combination to placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Comparison of probiotics, fish oil and their combination to placebo
Other Intervention Name(s)
Lactobacillus and Bifidobacterium, Fish oil, Placebo, microcrystalline cellulose, Placebo, medium-chain triglycerides
Intervention Description
Double-blind randomized placebo controlled intervention
Primary Outcome Measure Information:
Title
Prevalence of gestational diabetes mellitus, GDM
Time Frame
Assessed at gestational weeks 24-28
Title
Fasting glucose levels
Time Frame
assessed at the third trimester of pregnancy
Title
Prevalence of allergy in child
Time Frame
assessed at 12 and 24 months of age
Secondary Outcome Measure Information:
Title
Need for medication for management of gestational diabetes mellitus GDM (insulin or metformin)
Time Frame
During pregnancy
Title
Body composition of mother
Time Frame
During and after pregnancy
Title
Immunologic and metabolic markers
Time Frame
During and after pregnancy
Title
Fecal microbiota
Time Frame
Before, during and after intervention
Title
Fasting serum glucose (mmol/l) (mother/ child)
Time Frame
Assessed at 5-6 years postpartum
Title
Fasting serum insulin (mU/l) (mother/child)
Time Frame
Assessed at 5-6 years postpartum
Title
Number of women with prediabetes using criteria defined by American Diabetes Association
Time Frame
Assessed at 5-6 years postpartum
Title
Number of women with metabolic syndrome using criteria defined by The International Diabetes Federation
Time Frame
Assessed at 5-6 yrs postpartum
Title
Risk for Type 2 diabetes using questionnaire (mother)
Time Frame
Assessed at 5-6 yrs postpartum
Title
Serum high sensitive C-reactive protein (mg/l) (mother/child)
Time Frame
Assessed at 5-6 yrs postpartum
Title
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
Title
Serum metabolomics by NMR (mother/child)
Time Frame
assessed at 5-6 yrs postpartum
Title
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
Title
Carotid intima media thickness by ultra sound (mother/child)
Time Frame
Assessed at 5-6 yrs postpartum
Title
Retinal microvasculature by digital retinal imaging (mother)
Time Frame
Assessed at 5-6 yrs postpartum
Title
Liver fat by ultra sound (mother)
Time Frame
Assessed at 5-6 yrs postpartum
Title
Liver health by ALAT (child/mother)
Time Frame
Assessed at 5-6 yrs postpartum
Title
Fecal microbiota composition (mother/child)
Time Frame
Assessed at 5-6 yrs postpartum
Title
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
Title
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
Title
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
Title
Cognitive development by Cantab test and Wechsler Preschool and Primary Scale of Intelligence (child)
Time Frame
Assessed at 5-6 yrs postpartum
Title
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
Title
Social emotional assessment by Behavior Rating Inventory of Executive Functions (child)
Time Frame
Assessed at 5-6 yrs postpartum
Title
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
Title
Infant temperament, Child Behavior Questionnaire (child)
Time Frame
Assessed at 5-6 yrs postpartum
Title
Child growth measured from weight (kg) and length (cm)
Time Frame
Assessed at 5-6 yrs postpartum
Title
Atopy by serum antigens and asthma by spirometry (child)
Time Frame
Assessed at 5-6 yrs postpartum
Title
Immunological cells from blood (child)
Time Frame
Assessed at 5-6 yrs postpartum
Title
Physical activity by questionnaires and activity monitor
Time Frame
Assessed at 5-6 yrs postpartum
Other Pre-specified Outcome Measures:
Title
Body composition, growth, development and metabolic markers of the child
Time Frame
0 to 24 months of age
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
pregnant, less than 17 gestational weeks
overweight
healthy
Exclusion Criteria:
Diabetes (type 1 or 2)
Coeliac disease
Increased bleeding tendency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsi Laitinen
Organizational Affiliation
University of Turku
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Turku
City
Turku
ZIP/Postal Code
20014
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
35344737
Citation
Houttu N, Mokkala K, Saleem WT, Virtanen S, Juhila J, Koivuniemi E, Pellonpera O, Tertti K, Luokola P, Sorsa T, Salonen A, Lahti L, Laitinen K. Potential pathobionts in vaginal microbiota are affected by fish oil and/or probiotics intervention in overweight and obese pregnant women. Biomed Pharmacother. 2022 May;149:112841. doi: 10.1016/j.biopha.2022.112841. Epub 2022 Mar 28.
Results Reference
derived
PubMed Identifier
35343768
Citation
Lotankar M, Mokkala K, Houttu N, Koivuniemi E, Sorensen N, Nielsen HB, Munukka E, Lahti L, Laitinen K. Distinct Diet-Microbiota-Metabolism Interactions in Overweight and Obese Pregnant Women: a Metagenomics Approach. Microbiol Spectr. 2022 Apr 27;10(2):e0089321. doi: 10.1128/spectrum.00893-21. Epub 2022 Mar 28.
Results Reference
derived
PubMed Identifier
35304048
Citation
Mokkala K, Gustafsson J, Vahlberg T, Vreugdenhil ACE, Ding L, Shiri-Sverdlov R, Plat J, Laitinen K. Serum CathepsinD in pregnancy: Relation with metabolic and inflammatory markers and effects of fish oils and probiotics. Nutr Metab Cardiovasc Dis. 2022 May;32(5):1292-1300. doi: 10.1016/j.numecd.2022.02.011. Epub 2022 Feb 23.
Results Reference
derived
PubMed Identifier
34846602
Citation
Pajunen L, Korkalo L, Koivuniemi E, Houttu N, Pellonpera O, Mokkala K, Shivappa N, Hebert JR, Vahlberg T, Tertti K, Laitinen K. A healthy dietary pattern with a low inflammatory potential reduces the risk of gestational diabetes mellitus. Eur J Nutr. 2022 Apr;61(3):1477-1490. doi: 10.1007/s00394-021-02749-z. Epub 2021 Nov 30.
Results Reference
derived
PubMed Identifier
33870484
Citation
Davidson SJ, Barrett HL, Price SA, Callaway LK, Dekker Nitert M. Probiotics for preventing gestational diabetes. Cochrane Database Syst Rev. 2021 Apr 19;4(4):CD009951. doi: 10.1002/14651858.CD009951.pub3.
Results Reference
derived
PubMed Identifier
32564244
Citation
Mokkala K, Houttu N, Koivuniemi E, Sorensen N, Nielsen HB, Laitinen K. GlycA, a novel marker for low grade inflammation, reflects gut microbiome diversity and is more accurate than high sensitive CRP in reflecting metabolomic profile. Metabolomics. 2020 Jun 20;16(7):76. doi: 10.1007/s11306-020-01695-x.
Results Reference
derived
PubMed Identifier
31529056
Citation
Mokkala K, Vahlberg T, Pellonpera O, Houttu N, Koivuniemi E, Laitinen K. Distinct Metabolic Profile in Early Pregnancy of Overweight and Obese Women Developing Gestational Diabetes. J Nutr. 2020 Jan 1;150(1):31-37. doi: 10.1093/jn/nxz220.
Results Reference
derived
PubMed Identifier
30967436
Citation
Pellonpera O, Mokkala K, Houttu N, Vahlberg T, Koivuniemi E, Tertti K, Ronnemaa T, Laitinen K. Efficacy of Fish Oil and/or Probiotic Intervention on the Incidence of Gestational Diabetes Mellitus in an At-Risk Group of Overweight and Obese Women: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial. Diabetes Care. 2019 Jun;42(6):1009-1017. doi: 10.2337/dc18-2591. Epub 2019 Apr 9.
Results Reference
derived
PubMed Identifier
27466607
Citation
Mokkala K, Roytio H, Munukka E, Pietila S, Ekblad U, Ronnemaa T, Eerola E, Laiho A, Laitinen K. Gut Microbiota Richness and Composition and Dietary Intake of Overweight Pregnant Women Are Related to Serum Zonulin Concentration, a Marker for Intestinal Permeability. J Nutr. 2016 Sep;146(9):1694-700. doi: 10.3945/jn.116.235358. Epub 2016 Jul 27.
Results Reference
derived
Links:
URL
http://www.utu.fi
Description
University of Turku
URL
http://www.tyks.fi
Description
Turku University Hospital
URL
https://sites.utu.fi/nutritionresearch/
Description
Research group www-pages
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Nutrition and Pregnancy Intervention Study
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