PregnancyNCT01922791

Nutrition and Pregnancy Intervention Study

A study of Pregnancy and Obesity, run by Turku University Hospital at 2 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pregnancy, Obesity, Gestational Diabetes Mellitus
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 439 participants
Where: 2 sitesFinland
Study dates: Oct 2013to Mar 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

pregnant, less than 17 gestational weeks
overweight
healthy

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Finland2 sites

University of Turku
Turku, 20014
Turku University Hospital
Turku, 20521

Other trials in Finland

About this study

Official title: Placebo-controlled Intervention Study for Maternal and Child Health

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.

Conditions: Pregnancy, Obesity, Gestational Diabetes Mellitus, Adiposity, Type2 Diabetes, Cardiovascular Risk Factor
Being tested: Comparison of probiotics, fish oil and their combination to placebo
Keywords: Nutrition, Probiotics, Fish oil
Medical subject headings: Obesity, Diabetes, Gestational, Feeding Behavior, Liver Diseases, Neurodevelopmental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Comparison of probiotics, fish oil and their combination to placeboDietary supplement
Also called Lactobacillus and Bifidobacterium, Fish oil, Placebo, microcrystalline cellulose, Placebo, medium-chain triglycerides
Double-blind randomized placebo controlled intervention

Study groups in NCT01922791
Study group	Role	What they receive
Probiotic	Active comparator	Comparison of probiotics, fish oil and their combination to placebo Receives: Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo
Fish oil	Active comparator	Comparison of probiotics, fish oil and their combination to placebo Receives: Dietary Supplement: 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 Receives: Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo
Placebo	Placebo comparator	Comparison of probiotics, fish oil and their combination to placebo Receives: Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Prevalence of gestational diabetes mellitus, GDM
Measured: Assessed at gestational weeks 24-28
Fasting glucose levels
Measured: assessed at the third trimester of pregnancy
Prevalence of allergy in child
Measured: assessed at 12 and 24 months of age

Secondary outcomes (30)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Mar 2023

First posted14 Aug 2013 (estimated)
Study startOct 2013
Primary completionDec 2017
Study completionMar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for PregnancyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 439 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01922791
Sponsor's protocol ID: T166/2012
Status last verified: Apr 2023
First submitted: 12 Aug 2013
Last updated: 13 Apr 2023
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 41127037
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.
PubMed 41098558
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.
PubMed 40891102
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.
PubMed 40491247
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.
PubMed 40348632
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.
PubMed 39870192
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.
PubMed 38873899
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.
PubMed 36705702
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.
PubMed 35344737
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.
PubMed 35343768
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.
PubMed 35304048
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.
PubMed 34846602
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.
PubMed 33870484
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.
PubMed 32564244
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.
PubMed 31529056

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Placebo-controlled Intervention Study for Maternal and Child Health
ClinicalTrials.gov ID: NCT01922791
Acronym / sponsor ID: T166/2012
Conditions: Pregnancy, Obesity, Gestational Diabetes Mellitus, Adiposity, Type2 Diabetes, Cardiovascular Risk Factor
Keywords: Nutrition, Probiotics, Fish oil
Study type: Interventional
Recruitment status: Completed
Enrolment: 439 participants (actual)
Lead sponsor: Turku University HospitalOther government
Collaborators: University of Turku
Study start: Oct 2013 (actual)
Primary completion: Dec 2017 (actual)
Study completion: Mar 2023 (actual)
First posted: 14 Aug 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Probiotic	Active comparator	Dietary Supplement: Comparison of probiotics, fish oil and their combination to placeboComparison of probiotics, fish oil and their combination to placebo
Fish oil	Active comparator	Dietary Supplement: Comparison of probiotics, fish oil and their combination to placeboComparison of probiotics, fish oil and their combination to placebo
Probiotics and Fish oil	Active comparator	Dietary Supplement: Comparison of probiotics, fish oil and their combination to placeboComparison of probiotics, fish oil and their combination to placebo
Placebo	Placebo comparator	Dietary Supplement: Comparison of probiotics, fish oil and their combination to placeboComparison of probiotics, fish oil and their combination to placebo

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

pregnant, less than 17 gestational weeks
overweight
healthy

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Comparison of probiotics, fish oil and their combination to placeboAlso: Lactobacillus and Bifidobacterium, Fish oil, Placebo, microcrystalline cellulose, Placebo, medium-chain triglyceridesDouble-blind randomized placebo controlled intervention	Dietary supplement	Fish oil, Placebo, Probiotic, Probiotics and Fish oil

Primary outcome

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

30 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
Derived from this study: PubMed 41127037Houttu 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.
Derived from this study: PubMed 41098558Muhli 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.
Derived from this study: PubMed 40891102Seitz 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.
Derived from this study: PubMed 40491247Saros 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.
Derived from this study: PubMed 40348632Lotankar 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.
Derived from this study: PubMed 39870192Saros 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.
Derived from this study: PubMed 38873899Viitaharju 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.
Derived from this study: PubMed 36705702Saros 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.
Derived from this study: PubMed 35344737Houttu 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.
Derived from this study: PubMed 35343768Lotankar 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.
Derived from this study: PubMed 35304048Mokkala 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.
Derived from this study: PubMed 34846602Pajunen 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.
University of TurkuLink provided by the sponsor.
Research group www-pagesLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kirsi Laitinen principal investigator

University of Turku

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Pregnancy and Obesity, run by Turku University Hospital at 2 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of gestational diabetes mellitus, GDM (time frame: Assessed at gestational weeks 24-28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01922791, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.