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
Abstract
OBJECTIVE: To assess whether the risk of gestational diabetes mellitus (GDM) may be lowered and glucose metabolism improved by daily administration of fish oil and/or probiotic supplements in overweight and obese pregnant women. RESEARCH DESIGN AND METHODS: We randomized in a double-blind manner 439 women (mean 13.9 ± 2.1 gestational weeks [gw]) into four intervention groups: fish oil + placebo, probiotics + placebo, fish oil + probiotics, and placebo + placebo. Fish oil (1.9 g docosahexaenoic acid and 0.22 g eicosapentaenoic acid) and probiotic supplements (Lactobacillus rhamnosus HN001 and Bifidobacterium animalis ssp. lactis 420, 1010 colony-forming units each) were provided for daily consumption from randomization beyond delivery. Primary outcomes were the incidence of GDM diagnosed with oral glucose tolerance test targeted at 24–28 gw and the change in fasting glucose between randomization and late pregnancy (mean 35.2 ± 0.9 gw). Insulin concentration, insulin resistance HOMA2-IR index, and pregnancy outcomes were determined, as were adverse effects related to the intervention. Analyses were by intent to treat. RESULTS: No differences were found among the intervention groups in the maternal and neonatal pregnancy outcomes or side effects related to the intervention (P > 0.05). The proportion of women with GDM (94 of 377; fish oil + placebo, 23 of 96, 24.0%; probiotics + placebo, 25 of 99, 25.3%; fish oil + probiotics, 26 of 91, 28.6%; and placebo + placebo, 20 of 91, 22.0%) and the change in glucose, insulin, or HOMA2-IR (n = 364) did not differ among the intervention groups (P > 0.11 for all comparisons). CONCLUSIONS: An intervention with fish oil and/or probiotics during pregnancy seemed to be both safe and well tolerated but conferred no benefits in lowering the risk of GDM or improving glucose metabolism in overweight and obese women.
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Studies on the beneficial effects of probiotics in the prevention or treatment of GDM have inconclusive results.
“However, in the conducted studies on the beneficial effects of probiotics in the prevention or treatment of GDM, the results are still inconclusive [88,89,90,91].”
From Gestational Diabetes Mellitus—Recent Literature Review (2022) · cites this paper as [88]
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“Nine studies based their intervention on the supplement inositol (myo-inositol, d-chiro-inositol or combination of both) [38, 39, 44, 68, 78, 79, 82, 83, 100] while four used probiotic supplementation (Lactobacillus and Bifidobacterium species) [36, 60, 77, 98].”
BackgroundZhang, T., Jiang, W.-R., Xia, Y., Mansell, T., Saffery, R., Cannon, R. D., de Seymour, J. V., Zou, Z., Xu, G., Han, T.-L., et al. (2021) · Clinical Nutrition · doi:10.1016/j.clnu.2021.01.046 · Cited by 27 · see citing works
Anti-diabetic properties of bioactive components from fish and milk
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Wan, J., & Ma, J. (2022) · Frontiers in Microbiology · doi:10.3389/fmicb.2022.927883 · Cited by 30 · see citing works
“In contrast, other studies prove no benefit (Callaway et al., 2019; Pellonperä et al., 2019; Shahriari et al., 2021).”
ResultIodine status in pregnant women and infants in Finland
Miles, E. A., Vahlberg, T. J., Calder, P. C., Houttu, N., Saros, L., Koivuniemi, E., Mokkala, K., & Laitinen, K. (2022) · European Journal of Nutrition · doi:10.1007/s00394-022-02852-9 · Cited by 25 · see citing works
“Details of the FOPP study design and methods have been previously described [12].”
MethodSelf-citationMcDougall, A. R. A., Nguyen, R., Nguyen, P., Allen, C. L., Cheang, S., Makama, M., Mills, K., Hastie, R. M., Ammerdorffer, A., Gülmezoglu, A. M., et al. (2024) · American Journal of Obstetrics & Gynecology MFM · doi:10.1016/j.ajogmf.2024.101322 · Cited by 26 · see citing works
Houttu, N., Mokkala, K., Saleem, W., Virtanen, S., Juhila, J., Koivuniemi, E., Pellonperä, O., Tertti, K., Luokola, P., Sorsa, T. A., et al. (2022) · Biomedicine & Pharmacotherapy · doi:10.1016/j.biopha.2022.112841 · Cited by 24 · see citing works
Self-citationLim, S. S., Takele, W. W., Vesco, K. K., Redman, L. M., Hannah, W., Bonham, M. P., Chen, M., Chivers, S. C., Fawcett Andrea, J., Grieger, J. A., et al. (2023) · Communications Medicine · doi:10.1038/s43856-023-00366-x · Cited by 27 · see citing works
Chen, J., Yang, Y., Yu, N., Sun, W., Yang, Y., & Zhao, M. (2022) · PLoS ONE · doi:10.1371/journal.pone.0267045 · Cited by 24 · see citing works
“The results of another randomized double-blind controlled trial found that supplementing with probiotics could not improve blood glucose, insulin and other related indicators [61].”
BackgroundPakmehr, A., Ejtahed, H., Shirzad, N., Hemmatabadi, M., Farhat, S., & Larijani, B. A. (2022) · Frontiers in Medicine · doi:10.3389/fmed.2022.1031915 · Cited by 25 · see citing works
Pérez-Castillo, Í. M., Castillo, R. F., Lasserrot-Cuadrado, A., Gallo-Vallejo, J. L., Rojas-Carvajal, A. M., & Cordero, M. J. A. (2021) · Nutrients · doi:10.3390/nu13010256 · Cited by 23 · see citing works
“Author/Country/Year of Acceptance for Publication/Trial Registration Sample Size at Randomization Groups Analyzed at Delivery Microorganism (Strain)/Dosage (Posology) + Additional Interventions Administration Vehicle Treatment Duration Main Clinical Outcome Risk of Bias Assessment Conflict of Interest Jafarnejad et al…”
BackgroundInfluentialTrifkovič, K. Č., Mičetić‐Turk, D., Kmetec, S., Strauss, M., Dahlen, H. G., Foster, J. P., & Fijan, S. (2022) · Healthcare · doi:10.3390/healthcare10060970 · Cited by 22 · see citing works
“The clinical trial by Hulkkonen and co-authors [49] did not contain information regarding the randomisation process, concealment of allocation to treatment groups, or blinding of outcome assessors; however, another publication[69] form the same clinical trial contained this information.”
BackgroundPellonperä, O., Vahlberg, T. J., Mokkala, K., Houttu, N., Koivuniemi, E., Tertti, K., Rönnemaa, T., & Laitinen, K. (2020) · British Journal Of Nutrition · doi:10.1017/s0007114520004407 · Cited by 20 · see citing works
“Details of the research design and methods have been previously described(17).”
BackgroundMethodSelf-citationHanson, L., VandeVusse, L., Forgie, M. M., Malloy, E., Singh, M., Scherer, M., Kleber, D., Dixon, J., Hryckowian, A. J., & Safdar, N. (2022) · American Journal of Obstetrics & Gynecology MFM · doi:10.1016/j.ajogmf.2022.100748 · Cited by 19 · see citing works
Wiedmer, E. B., & Herter‐Aeberli, I. (2022) · Frontiers in Nutrition · doi:10.3389/fnut.2022.819882 · Cited by 18 · see citing works
“(60) Double blind RCT Probiotic capsule|”
ResultWu, R., Luan, J., Hu, J., & Li, Z. (2024) · Archives of Gynecology and Obstetrics · doi:10.1007/s00404-023-07346-5 · Cited by 18 · see citing works
“Additionally, the preceding research featured obese and overweight pregnant women not diagnosed with GDM, which could have introduced biased results [42].”
Foodomics: a new perspective on gut probiotics nutrition and health research
He, M., Tan, C. P., Liu, Y., & Xu, Y. (2021) · Current Opinion in Food Science · doi:10.1016/j.cofs.2021.04.004 · Cited by 20 · see citing works
Unraveling the role of the gut microbiome in pregnancy disorders: insights and implications
Xie, Y., Chen, Q., Shan, D., Pan, X., & Hu, Y. (2025) · Frontiers in Cellular and Infection Microbiology · doi:10.3389/fcimb.2025.1521754 · Cited by 17 · see citing works
Ibrahim, I., Bashir, M., Singh, P., Khodor, S. A., & Abdullahi, H. (2022) · Frontiers in Nutrition · doi:10.3389/fnut.2022.867099 · Cited by 18 · see citing works
Saros, L., Vahlberg, T. J., Koivuniemi, E., Houttu, N., Niinikoski, H., Tertti, K., & Laitinen, K. (2022) · Journal of Pediatric Gastroenterology and Nutrition · doi:10.1097/mpg.0000000000003659 · Cited by 17 · see citing works
“The trial design has been described previously (22) (ClinicalTrials.”
MethodSelf-citationHuhtala, M. S., Rönnemaa, T., & Tertti, K. (2023) · Biomolecules · doi:10.3390/biom13030470 · Cited by 17 · see citing works
Self-citationIshimwe, J., Akinleye, A. A., Johnson, A. C., Garrett, M. R., & Sasser, J. M. (2021) · Physiological Genomics · doi:10.1152/physiolgenomics.00121.2020 · Cited by 17 · see citing works
Mokkala, K., Vahlberg, T. J., Houttu, N., Koivuniemi, E., Lahti, L., & Laitinen, K. (2021) · EBioMedicine · doi:10.1016/j.ebiom.2021.103655 · Cited by 17 · see citing works
“These were predefined secondary outcomes of the main study (the primary outcome has been reported earlier) [9].”
BackgroundMethodResultInfluentialSelf-citationVentura, E. F., Lane, J. A., Turjeman, S. C., Vidra, N., Weiss, G. A., Gross, G., Chang, C.-Y., & Koren, O. (2025) · Gut Microbes · doi:10.1080/19490976.2025.2501186 · Cited by 16 · see citing works
“…(HN001) and B. animalis subsp. lactis (420) (10 10 CFU each), taken with or without fish oil, did not show any effects compared to placebo, 43 and also a fourth study, with L . acidophilus (LA1) (>7.5 × 10 9 CFU), B. longum (sp54 cs) (>1.5 × 10 9 CFU), and B. bifidum (sp9 cs) (>6 × 10 9…”
InfluentialOmega-3 fats in pregnancy: could a targeted approach lead to better metabolic health for children?
Satokar, V. V., Cutfield, W. S., Cameron‐Smith, D., & Albert, B. B. (2020) · Nutrition Reviews · doi:10.1093/nutrit/nuaa071 · Cited by 16 · see citing works
Maternal fish oil and/or probiotics intervention: Allergic diseases in children up to two years old
Komulainen, M., Saros, L., Vahlberg, T. J., Nermes, M., Jartti, T. T., & Laitinen, K. (2023) · Pediatric Allergy and Immunology · doi:10.1111/pai.14004 · Cited by 15 · see citing works
Self-citationLi, Y., Xiao, C., Ren, H., Li, W., Guo, Z., & Luo, J. (2024) · Food & Function · doi:10.1039/d3fo04456d · Cited by 15 · see citing works
Gupta, A., Chan, S., Toh, R., Low, J. M., Liu, I., Lim, S. L., Lee, L. Y., & Swarup, S. (2024) · Scientific Reports · doi:10.1038/s41598-024-60386-y · Cited by 15 · see citing works
Ma, G., Yan, H., Tye, K. D., Tang, X., Luo, H., Li, Z., & Xiao, X. (2024) · Microbiology Spectrum · doi:10.1128/spectrum.00413-24 · Cited by 15 · see citing works
Amirani, E., Asemi, Z., Asbaghi, O., Milajerdi, A., Reiner, Ž., Mansournia, M. A., Hallajzadeh, J., Moazzami, B., & Chaichian, S. (2020) · Journal of Diabetes & Metabolic Disorders · doi:10.1007/s40200-020-00558-5 · Cited by 15 · see citing works
Houttu, N., Mokkala, K., Koivuniemi, E., Pellonperä, O., Juhila, J., Sorsa, T. A., & Laitinen, K. (2020) · Biomolecules · doi:10.3390/biom11010005 · Cited by 15 · see citing works
Self-citationSatokar, V. V., Derraik, J. G. B., Harwood, M. L. N., Okesene-Gafa, K. A. M., Beck, K. L., Cameron‐Smith, D., Garg, M. L., O'Sullivan, J. M., Sundborn, G., Pundir, S., et al. (2023) · American Journal of Clinical Nutrition · doi:10.1016/j.ajcnut.2023.02.007 · Cited by 16 · see citing works
Mokkala, K., Vahlberg, T. J., Houttu, N., Koivuniemi, E., & Laitinen, K. (2020) · Obesity · doi:10.1002/oby.22882 · Cited by 15 · see citing works
“and probiotics) in the main trial had no influence on the incidence of GDM or glucose metabolism (9) but was nevertheless included as a covariate in the analysis.”
BackgroundSelf-citationNachum, Z., Perlitz, Y., Shavit, L. Y., Magril, G., Vitner, D., Zipori, Y., Weiner, E., Alon, A. S., Ganor‐Paz, Y., Nezer, M., et al. (2023) · American Journal of Obstetrics & Gynecology MFM · doi:10.1016/j.ajogmf.2023.101224 · Cited by 17 · see citing works
Li, Z., Li, Y., Pan, B., Wang, X., Wu, Y. F., Guo, K., Yang, M., Ma, M., Qiao, C., & Yang, K. (2022) · Probiotics and Antimicrobial Proteins · doi:10.1007/s12602-022-10037-3 · Cited by 14 · see citing works
Beverage Intake and the Risk of Gestational Diabetes Mellitus: The SECOST
Yong, H. Y., Shariff, Z. M., Yusof, B. N. M., Rejali, Z., Tee, Y. Y. S., BINDELS, J. G., & van der Beek, E. M. (2021) · Nutrients · doi:10.3390/nu13072208 · Cited by 14 · see citing works
“The association between fermented milk consumption and reduced T2DM risk has been consistently reported [30], but there are minimal investigations on the impacts of fermented milk consumption on GDM risk [31,32].”
BackgroundThe role of gut microbiome in prevention, diagnosis and treatment of gestational diabetes mellitus
Tsarna, E., & CHRISTOPOULOS, P. F. (2021) · Journal of Obstetrics and Gynaecology · doi:10.1080/01443615.2021.1959534 · Cited by 14 · see citing works
Joshi, N. P., Jadhav, A. T., Godhamgaonkar, A. A., Sundrani, D. P., Randhir, K., Pisal, H., Wagh, G. N., Krishnaveni, G. V., Gupte, S., & Joshi, S. (2024) · Food & Function · doi:10.1039/d3fo05348b · Cited by 13 · see citing works
Li, X., Zhang, L., He, Y., Zhang, D., & Zhang, S. (2024) · Biomolecules and Biomedicine · doi:10.17305/bb.2024.10377 · Cited by 12 · see citing works
Nutraceuticals in Pregnancy: A Special Focus on Probiotics
Perna, A., Venditti, N., Merolla, F., Fusco, S., Guerra, G., Zoroddu, S., Luca, A. D., & Bagella, L. (2024) · International Journal of Molecular Sciences · doi:10.3390/ijms25179688 · Cited by 12 · see citing works
Diet intake and adherence to recommendations in women with gestational diabetes mellitus
Saros, L., Vahlberg, T. J., Pellonperä, O., Tertti, K., & Laitinen, K. (2025) · European Journal of Clinical Nutrition · doi:10.1038/s41430-025-01596-z · Cited by 13 · see citing works
Self-citationHouttu, N., Vahlberg, T. J., Miles, E. A., Calder, P. C., & Laitinen, K. (2023) · British Journal Of Nutrition · doi:10.1017/s0007114523001915 · Cited by 12 · see citing works
“Even though the power calculations were done based on the reduction of incidence of GDM and fasting glucose levels (14) , we are confident that the power with this high number of study subjects is sufficient to detect changes in fatty acid levels after the dietary intervention, compared with…”
InfluentialSelf-citationCalancie, L., Brown, M. O., Choi, W. A., Caouette, J. L., McCann, J., Nam, E. Y., & Werner, E. F. (2025) · American Journal of Obstetrics & Gynecology MFM · doi:10.1016/j.ajogmf.2025.101606 · Cited by 14 · see citing works
Zhang, L., Hu, X., Wang, Y., He, C., Yu, J., Fang, X., Zhang, Y., Xu, X., & Yang, J. J. (2022) · Food & Function · doi:10.1039/d1fo04333a · Cited by 11 · see citing works
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Kassaa, I. A., & Fuad, M. (2024) · Nutrients · doi:10.3390/nu16172936 · Cited by 11 · see citing works
Probiotic Intervention in the Treatment of Diabetes Mellitus: A Review
Sreepathi, N., Jayanthi, M. K., Chandra, S. J., Bajpe, S. N., & Ramu, R. (2022) · Journal of Pure and Applied Microbiology · doi:10.22207/jpam.16.3.25 · Cited by 10 · see citing works
Zhang, C., Sheng, Y., Jiang, J., Xue, Y., Yu, L., Tian, F., Zhao, J., Zhang, H., Jin, J., & Zhai, Q. (2022) · Food Science and Human Wellness · doi:10.1016/j.fshw.2022.10.023 · Cited by 10 · see citing works
Progress of Clinical Trials for the Treatment of Gestational Diabetes Mellitus
Chen, T., Liu, D., & Yao, X. (2021) · Diabetes Metabolic Syndrome and Obesity · doi:10.2147/dmso.s290749 · Cited by 10 · see citing works
Nulens, K., Papy, E., Tartaglia, K., Dehaene, I., Logghe, H., Keirsbilck, J. V., Chantraine, F., Masson, V., Simoens, E., GYSEMANS, W., et al. (2024) · Trials · doi:10.1186/s13063-024-08444-8 · Cited by 8 · see citing works
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Chen, X., Pan, L., Zhang, Z., Niu, R., Zhang, H., & Ma, T. (2022) · Zeitschrift für Geburtshilfe und Neonatologie · doi:10.1055/a-1956-3927 · Cited by 7 · see citing works
“…CI) Asgharian 2020 Heterogeneity: Tau2 = 0.04; Chi2 = 11.94, df = 3 (P = 0.008); I2 = 75 % Test for overall effect: Z = 0.40 (P = 0.69) Wickens 2017 Pellonperä 2019 Callaway 2019 74.8 4.32 26.3 79.3 64 195 110 207 77.9 4.4 26.2 77.5 64 202 110 204 19.9 % 27.8 % 24.2 % 28.0 % – 0.32 [– 0.67,…”
InfluentialSoukka, J. J. H., Polari, L., Kalliomäki, M. A., Saros, L., Laajala, T. D., Vahlberg, T. J., Toivola, D. M., & Laitinen, K. (2023) · Molecular Nutrition & Food Research · doi:10.1002/mnfr.202200446 · Cited by 7 · see citing works
Self-citationPoulios, E., Pavlidou, E., Papadopoulou, S. Κ., Rempetsioti, K., Migdanis, A., Mentzelou, M., Chatzidimitriou, M., Migdanis, I., Androutsos, O., & Giaginis, C. (2024) · Biology · doi:10.3390/biology13030158 · Cited by 8 · see citing works
“In contrast to the previous studies, no considerable relation of probiotics supplementation with the kind of delivery was noted in the above survey [105].”
MethodResultInfluentialImproved breast milk proteome coverage by DIA based LC‐MS/MS method
Viitaharju, J., Polari, L., Kauko, O., Merilahti, J. A. M., Rokka, A., Toivola, D. M., & Laitinen, K. (2024) · PROTEOMICS · doi:10.1002/pmic.202300340 · Cited by 7 · see citing works
“The clinical study design has been described previously in detail [17].”
Self-citationMicrobiome-based therapeutics: Opportunity and challenges
Pant, A., & Das, B. (2022) · Progress in molecular biology and translational science · doi:10.1016/bs.pmbts.2022.07.006 · Cited by 8 · see citing works
Gut Health for Two: the Critical Role of Probiotics and Prebiotics in Pregnancy and Lactation
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Predictive Gestational Diabetes Biomarkers With Sustained Alterations Throughout Pregnancy
Heath, H., Luevano, J., Johnson, C., Phelan, S., & Frano, M. R. L. (2022) · Journal of the Endocrine Society · doi:10.1210/jendso/bvac134 · Cited by 6 · see citing works
“Supplementation with fish oils, which might be expected to help normalize oxylipin levels, has not been shown to reduce risk of GDM [122, 123].”
BackgroundScientific Opinion on the tolerable upper intake level for supplemental docosahexaenoic acid
Nutrition, N. F. A. F. A. (. E. P. O., Turck, D., Bohn, T., Cámara, M., Castenmiller, J. J. M., Henauw, S. D., Hirsch‐Ernst, K. I., Jos, A. M., Maciuk, A., Mangelsdorf, I., et al. (2026) · EFSA Journal · doi:10.2903/j.efsa.2026.9858 · Cited by 5 · see citing works
“In another study involving pregnant women with overweight and obesity, participants were instructed to maintain a weekly diary to document any potential adverse effects (Pellonperä et al., 2019).”
InfluentialLim, S. S., Takele, W. W., Vesco, K. K., Redman, L. M., ADA PMDI GDM prevention working group, & Josefson, J. L. (2023) · medRxiv · doi:10.1101/2023.04.16.23288650 · Cited by 5 · see citing works
“72) (27), however three studies with probiotics-only (28-31) and one study with fish oil-plus probiotics (31) did not reduce GDM (RR ranging from 0.”
BackgroundResilience to Global Health Challenges Through Nutritional Gut Microbiome Modulation
Isolauri, E., & Laitinen, K. (2025) · Nutrients · doi:10.3390/nu17030396 · Cited by 4 · see citing works
“Since this study, several studies with different probiotics have been conducted, although with controversial findings [65].”
Self-citation
- Authors
- Pellonperä, O., Mokkala, K., Houttu, N., Vahlberg, T., Koivuniemi, E., Tertti, K., Rönnemaa, T., & Laitinen, K.
- Affiliations
- University of Turku (FI)
- Corresponding author
- Pellonperä, Outi
- ORCID
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2019-04-09
- Volume
- 42
- Issue
- 6
- Pages
- 1009-1017
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W2938463432
- Cited by
- 145
- References
- 42
- Citations by year
- 2026: 13 · 2025: 23 · 2024: 21 · 2023: 14 · 2022: 33 · 2021: 22 · 2020: 15 · 2019: 4
- FWCI
- 20.15
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Academy of Finland (258606)
- state research funding for university-level health research of the Turku University Hospital Expert Responsibility Area
- Diabetes Research Foundation
- Juho Vainio Foundation
- Business Finland (3486/31/2015)
- The Finnish Medical Foundation
- Topics
- Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Keywords
- gestational diabetes mellitus, fish oil supplementation, probiotics, docosahexaenoic acid, eicosapentaenoic acid, Lactobacillus rhamnosus HN001, Bifidobacterium animalis subsp. lactis, overweight in pregnancy, maternal obesity, glucose metabolism, insulin resistance, HOMA2-IR, fasting blood glucose, pregnancy outcomes, neonatal outcomes
- MeSH terms
- Adult, Double-Blind Method, Female, Fish Oils, Glucose Tolerance Test, Humans, Insulin Resistance, Obesity, Placebos, Pregnancy, Pregnancy Complications, Pregnancy Outcome, Risk Factors, Incidence, Diabetes, Gestational, Treatment Outcome, Dietary Supplements, Probiotics, Overweight
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