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| Name | Class |
|---|---|
| University of Turku | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator | Comparison of probiotics, fish oil and their combination to placebo |
|
| Fish oil | Active Comparator | Comparison of probiotics, fish oil and their combination to placebo |
|
| Probiotics and Fish oil | Active Comparator | Comparison of probiotics, fish oil and their combination to placebo |
|
| Placebo | Placebo Comparator | Comparison of probiotics, fish oil and their combination to placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparison of probiotics, fish oil and their combination to placebo | Dietary Supplement | Double-blind randomized placebo controlled intervention |
|
| 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 |
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition, growth, development and metabolic markers of the child | 0 to 24 months of age |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsi Laitinen | University of Turku | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Turku | Turku | 20014 | Finland | |||
| Turku University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41127037 | Derived | Houttu V, Mongad D, Houttu N, Saros L, Zhang C, Viitaharju J, Vahlberg T, Lahti L, Laitinen K. The Impact of Maternal Supplementation of Fish Oil and/or Probiotics During Pregnancy on the Serum Metabolomic Profile From Infancy to Childhood: Secondary Analysis of a Randomized Placebo-Controlled Trial. Curr Dev Nutr. 2025 Sep 9;9(10):107553. doi: 10.1016/j.cdnut.2025.107553. eCollection 2025 Oct. | |
| 41098558 |
| Label | URL |
|---|---|
| University of Turku | View source |
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|
| 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 |
| Turku |
| 20521 |
| Finland |
| Derived |
| Muhli E, Vahlberg T, Saros L, Houttu N, Pellonpera O, Tertti K, Laitinen K. Postpartum Body Composition in Women With Overweight: Associations With Diet During Pregnancy. Obes Sci Pract. 2025 Oct 13;11(5):e70093. doi: 10.1002/osp4.70093. eCollection 2025 Oct. |
| 40891102 | Derived | Seitz T, Viitaharju J, Benchraka C, Merilahti J, Kalliomaki M, Polari L, Toivola D, Lahti L, Kauko O, Laitinen K. Breast Milk Proteome: Changes in the Different Stages of Lactation and Impacts of Gestational Diabetes Mellitus and Body Mass Index. Mol Nutr Food Res. 2025 Nov;69(22):e70225. doi: 10.1002/mnfr.70225. Epub 2025 Sep 1. |
| 40491247 | Derived | Saros L, Vahlberg T, Koivuniemi E, Houttu N, Tertti K, Shivappa N, Hebert JR, Niinikoski H, Laitinen K. Maternal diet and gestational diabetes mellitus modestly influence children's growth during their first 24 months. J Pediatr Gastroenterol Nutr. 2025 Aug;81(2):355-366. doi: 10.1002/jpn3.70098. Epub 2025 Jun 9. |
| 40348632 | Derived | Lotankar M, Houttu N, Benchraka C, Lahti L, Laitinen K. Links between gut microbiota with specific serum metabolite groups in pregnant women with overweight or obesity. Nutr Metab Cardiovasc Dis. 2025 Sep;35(9):104095. doi: 10.1016/j.numecd.2025.104095. Epub 2025 Apr 16. |
| 39870192 | Derived | Saros L, Setanen S, Hieta J, Kataja EL, Suorsa K, Vahlberg T, Tertti K, Niinikoski H, Stenholm S, Jartti T, Laitinen K. The effect of maternal risk factors during pregnancy on children's motor development at 5-6 years. Clin Nutr ESPEN. 2025 Apr;66:236-244. doi: 10.1016/j.clnesp.2025.01.047. Epub 2025 Jan 25. |
| 38873899 | Derived | Viitaharju J, Polari L, Kauko O, Merilahti J, Rokka A, Toivola DM, Laitinen K. Improved breast milk proteome coverage by DIA based LC-MS/MS method. Proteomics. 2024 Jul;24(14):e2300340. doi: 10.1002/pmic.202300340. Epub 2024 Jun 14. |
| 36705702 | Derived | Saros L, Vahlberg T, Koivuniemi E, Houttu N, Niinikoski H, Tertti K, Laitinen K. Fish Oil And/Or Probiotics Intervention in Overweight/Obese Pregnant Women and Overweight Risk in 24-Month-Old Children. J Pediatr Gastroenterol Nutr. 2023 Feb 1;76(2):218-226. doi: 10.1097/MPG.0000000000003659. Epub 2022 Nov 23. |
| 35344737 | Derived | 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. |
| 35343768 | Derived | 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. |
| 35304048 | Derived | 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. |
| 34846602 | Derived | 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. |
| 33870484 | Derived | 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. |
| 32564244 | Derived | 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. |
| 31529056 | Derived | 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. |
| 30967436 | Derived | 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. |
| 27466607 | Derived | 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. |
| Research group www-pages | View source |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D016640 | Diabetes, Gestational |
| D005247 | Feeding Behavior |
| D008107 | Liver Diseases |
| D065886 | Neurodevelopmental Disorders |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D004066 | Digestive System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| C100843 | Lacteol |
| C109691 | microcrystalline cellulose |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
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