Clinical trial NCT01922791: Nutrition and Pregnancy Intervention Study
Official title: Placebo-controlled Intervention Study for Maternal and Child Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Turku
First posted: 2013-08-14
Enrollment: 439
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Prevalence of gestational diabetes mellitus, GDM
timeFrame: Assessed at gestational weeks 24-28
measure: Fasting glucose levels
timeFrame: assessed at the third trimester of pregnancy
measure: Prevalence of allergy in child
timeFrame: assessed at 12 and 24 months of age
Secondary outcomes:
measure: Need for medication for management of gestational diabetes mellitus GDM (insulin or metformin)
timeFrame: During pregnancy
measure: Body composition of mother
timeFrame: During and after pregnancy
measure: Immunologic and metabolic markers
timeFrame: During and after pregnancy
measure: Fecal microbiota
timeFrame: Before, during and after intervention
measure: Fasting serum glucose (mmol/l) (mother/ child)
timeFrame: Assessed at 5-6 years postpartum
measure: Fasting serum insulin (mU/l) (mother/child)
timeFrame: Assessed at 5-6 years postpartum
measure: Number of women with prediabetes using criteria defined by American Diabetes Association
timeFrame: Assessed at 5-6 years postpartum
measure: Number of women with metabolic syndrome using criteria defined by The International Diabetes Federation
timeFrame: Assessed at 5-6 yrs postpartum
measure: Risk for Type 2 diabetes using questionnaire (mother)
timeFrame: Assessed at 5-6 yrs postpartum
measure: Serum high sensitive C-reactive protein (mg/l) (mother/child)
timeFrame: Assessed at 5-6 yrs postpartum
measure: Lipid metabolism (fasting cholesterol (mmol/l), fasting triglycerides (mmol/l), fasting HDL-cholesterol (mmol/l), fasting LDL-cholesterol (mmol/l) (mother/child)
timeFrame: Assessed at 5-6 yrs postpartum
measure: Serum metabolomics by NMR (mother/child)
timeFrame: assessed at 5-6 yrs postpartum
measure: Obesity by body mass index (mother/child) and body fat percentage by air displacement plethysmography (mother/child)
timeFrame: Assessed at 5-6 yrs postpartum
measure: Carotid intima media thickness by ultra sound (mother/child)
timeFrame: Assessed at 5-6 yrs postpartum
measure: Retinal microvasculature by digital retinal imaging (mother)
timeFrame: Assessed at 5-6 yrs postpartum
measure: Liver fat by ultra sound (mother)
timeFrame: Assessed at 5-6 yrs postpartum
measure: Liver health by ALAT (child/mother)
timeFrame: Assessed at 5-6 yrs postpartum
measure: Fecal microbiota composition (mother/child)
timeFrame: Assessed at 5-6 yrs postpartum
measure: 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
timeFrame: Assessed at 5-6 yrs postpartum
measure: Eating behavior by Three Factor Eating Questionnaire, Neofobia and Comprehensive Feeding Practices Questionnaire, Child Feeding Questionnaire, Child Eating Behaviour Questionnaire (child)
timeFrame: Assessed at 5-6 yrs postpartum
measure: Motor development by Movement Assessment Battery for Children and by Developmental Coordination Disorder Questionnaire 2007 (DCDQ'07) (Child)
timeFrame: Assessed at 5-6 yrs postpartum
measure: Cognitive development by Cantab test and Wechsler Preschool and Primary Scale of Intelligence (child)
timeFrame: Assessed at 5-6 yrs postpartum
measure: Child effortful/emotionally-driven inhibition by the Forbidden Toy task and by Delay of gratification test (child)
timeFrame: Assessed at 5-6 yrs postpartum
measure: Social emotional assessment by Behavior Rating Inventory of Executive Functions (child)
timeFrame: Assessed at 5-6 yrs postpartum
measure: 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)
timeFrame: Assessed at 5-6 yrs postpartum
measure: Infant temperament, Child Behavior Questionnaire (child)
timeFrame: Assessed at 5-6 yrs postpartum
measure: Child growth measured from weight (kg) and length (cm)
timeFrame: Assessed at 5-6 yrs postpartum
measure: Atopy by serum antigens and asthma by spirometry (child)
timeFrame: Assessed at 5-6 yrs postpartum
measure: Immunological cells from blood (child)
timeFrame: Assessed at 5-6 yrs postpartum
measure: Physical activity by questionnaires and activity monitor
timeFrame: Assessed at 5-6 yrs postpartum
Other outcomes:
measure: Body composition, growth, development and metabolic markers of the child
timeFrame: 0 to 24 months of age
Locations:
city: Turku
country: Finland
facility: University of Turku
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: University of Turku
name: Kirsi Laitinen
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.