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The Effect of Regular Consumption of Reformulated Breads on Glycemic Control: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.
Schadow, AM, Revheim, I, Spielau, U, Dierkes, J, Schwingshackl, L, Frank, J, Hodgson, JM, Moreira-Rosário, A, Seal, CJ, Buyken, AE, et al
Advances in nutrition (Bethesda, Md.). 2023;14(1):30-43
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The metabolic effect of bread depends on several qualitative aspects ranging from the type of grain, the amount of carbohydrates, levels of other nutrients, as well as the chemical structure and processing. The aim of this study was to assess the certainty of the evidence and to investigate the overall effect of regular consumption of reformulated breads on glycaemic control in the following groups: a) healthy adults; b) those at risk of developing cardiometabolic disease (e.g., having hypertension, hyperglycaemia, hypercholesterolemia and/or overweight/obesity); and c) those with manifest type 2 diabetes mellitus (T2DM). This study is a systematic review and meta-analysis of 22 studies and 23 distinct study populations. All studies were randomised controlled trials, 12 of which had a crossover design and 10 had a parallel design. In total, 1037 participants were included. These provided 669 and 595 data points for intervention and control comparisons, respectively. Results show a beneficial effect of reformulated bread variants on fasting blood glucose concentrations. This benefit may be more pronounced among people with manifest T2DM (low certainty of evidence). Authors conclude that bread quality is relevant for metabolic health among adults and that future studies should address its relevance among people at risk of T2DM.
Expert Review
Conflicts of interest:
None
Take Home Message:
This study’s findings suggest the effect of reformulated breads high in dietary fibre, whole grains, and/or functional ingredients may be more beneficial than regular breads on fasting blood glucose concentrations in adults, primarily among those with T2DM. Reformulated breads however, did not lower fasting insulin concentrations, HOMA-IR and HbA1C when compared to regular bread.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Overview
This study evaluated the effect of regular consumption of “reformulated breads” on glycemic control among healthy adults, adults at cardiometabolic risk or with manifest T2DM in 22 RCTs with 1037 participants. Compared with “regular” or comparator bread, consumption of reformulated intervention breads yielded lower fasting blood glucose concentrations only among people with T2DM (low certainty of evidence), yet no differences in fasting insulin, HOMA-IR, HbA1c, or postprandial glucose response were identified.
[*’reformulated bread’ as defined by the World Health Organisation of altering the processing or composition of a food to improve its nutritional profile, and contained whole-grains and dietary fibre]
Results
Sub group analysis revealed that the effect of reformulated breads high in dietary fibre, whole grains, and/or functional ingredients on lowering fasting blood glucose was confined to participants with T2DM, with no significant effect among participants without T2DM (0.68 mmol/L; 95% CI: 1.11, 0.36; I2 1⁄4 57% and 0.04 mmol/L; 95% CI: 0.13, 0.05; I2 1⁄4 25%, respectively; P < 0.001).
Subgroup analyses by continent revealed a more pronounced effect on fasting blood glucose concentrations in studies conducted in Asia and the Middle East compared with studies conducted in Europe, North America, and Oceania (MD: 0.84 mmol/L; 95% CI: 1.35, 0.33; I2 1⁄4 52% and MD: 0.04 mmol/L; 95% CI: 0.10, 0.03; I2 1⁄4 0%, respectively; P < 0.001)
Additional subgroup analyses found that the type of control bread, but not the type of intervention bread, affected the pooled effect estimate of fasting blood glucose concentration (P 1⁄4 0.03), with the largest difference reported in studies not describing the control bread used.
Limitations
Publication bias was considered negligible for the studies included in this meta-analysis, and the risk of bias assessment revealed that most of the studies had some concerns of risk of bias. One author is a member of the International Carbohydrate Quality Consortium and another is a member of the GRADE working group.
Strengths
This systematic review and meta-analysis include the focus on high-quality intervention studies (i.e., RCTs using either crossover or parallel design) and the inclusion of longer-term studies (>2 wk) to address the effectiveness of regular bread replacement for glycemic control in everyday life.
Clinical practice applications:
- This data suggests that bread quality is relevant for metabolic health among adults at risk of T2DM. In particular, reformulated breads were found to have a more beneficial impact than regular breads on fasting blood glucose concentrations in adults with TsDM. However, consumption of the reformulated bread (enriched with dietary fiber, whole grains, or functional ingredients) did not lower fasting insulin concentrations compared with the control breads (MD: 1.59 pmol/L; 95% CI: 5.78, 2.59; moderate certainty of evidence)
- Consumption of the reformulated bread did not lower HOMA-IR compared with the control breads (MD: 0.09; 95% CI: 0.35, 0.22; moderate certainty of evidence)
- Consumption of the reformulated bread did not lower HbA1c concentrations compared with the control bread (0.14; 95% CI: 0.39, 0.10; P 1⁄4 0.195; very low certainty of evidence).
Considerations for future research:
- Longer intervention periods may be required to determine the beneficial effects on the HbA1c concentrations and to elicit changes in markers of insulin resistance
- Future studies should use the 2022 WHO standardised HbA1c diagnostic reference criterion for diabetes mellitus
- Improvements in specific outcomes may also be linked to defined groups within populations such as persons with manifest T2DM.
- The type of reformulation of the bread may be an important factor but differ considerably around the world
Abstract
Bread is a major source of grain-derived carbohydrates worldwide. High intakes of refined grains, low in dietary fiber and high in glycemic index, are linked with increased risk for type 2 diabetes mellitus (T2DM) and other chronic diseases. Hence, improvements in the composition of bread could influence population health. This systematic review evaluated the effect of regular consumption of reformulated breads on glycemic control among healthy adults, adults at cardiometabolic risk or with manifest T2DM. A literature search was performed using MEDLINE, Embase, Web of Science and the Cochrane Central Register of Controlled Trials. Eligible studies employed a bread intervention (≥2 wk) in adults (healthy, at cardiometabolic risk or manifest T2DM) and reported glycemic outcomes (fasting blood glucose, fasting insulin, HOMA-IR, HbA1c, and postprandial glucose responses). Data were pooled using generic inverse variance with random-effects model and presented as mean difference (MD) or standardized MD between treatments with 95% CIs. Twenty-two studies met the inclusion criteria (n = 1037 participants). Compared with "regular" or comparator bread, consumption of reformulated intervention breads yielded lower fasting blood glucose concentrations (MD: -0.21 mmol/L; 95% CI: -0.38, -0.03; I2 = 88%, moderate certainty of evidence), yet no differences in fasting insulin (MD: -1.59 pmol/L; 95% CI: -5.78, 2.59; I2 = 38%, moderate certainty of evidence), HOMA-IR (MD: -0.09; 95% CI: -0.35, 0.23; I2 = 60%, moderate certainty of evidence), HbA1c (MD: -0.14; 95% CI: -0.39, 0.10; I2 = 56%, very low certainty of evidence), or postprandial glucose response (SMD: -0.46; 95% CI: -1.28, 0.36; I2 = 74%, low certainty of evidence). Subgroup analyses revealed a beneficial effect for fasting blood glucose only among people with T2DM (low certainty of evidence). Our findings suggest a beneficial effect of reformulated breads high in dietary fiber, whole grains, and/or functional ingredients on fasting blood glucose concentrations in adults, primarily among those with T2DM. This trial was registered at PROSPERO as CRD42020205458.
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The impact of diabetes mellitus type 1 on male fertility: Systematic review and meta-analysis.
Facondo, P, Di Lodovico, E, Delbarba, A, Anelli, V, Pezzaioli, LC, Filippini, E, Cappelli, C, Corona, G, Ferlin, A
Andrology. 2022;10(3):426-440
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The relationship between type 2 diabetes mellitus and male hypogonadism is well known, whereas the impact of type 1 diabetes mellitus (DM1) on male fertility and testis functions has been less studied. The aim of this study was to systematically review and discuss the available evidence evaluating paternity rate, male gonadal axis, and sperm parameters in men with DM1. This study is a systematic review and meta-analysis of fourteen studies. Results show: - reduced fertility potential in patients with DM1, as they have a lower number of children compared with unaffected population. In fact, the rate of children is statistically significantly lower among men who had been diagnosed with DM1 at an earlier age, according to a longer duration of the disease. - that men with DM1, compared with controls, have significantly lower normal sperm morphology, progressive motility and a trend toward a reduced semen volume, without difference in total sperm count and concentration. Authors conclude that DM1 might impair reproductive health at different levels, including functional sperm alterations definitively leading to reduced fertility rate in these patients.
Abstract
BACKGROUND Some evidence suggests that diabetes mellitus type 1 (DM1) could affect male fertility, gonadal axis, semen parameters, and spermatogenesis because of effects of hyperglycemia and insulin deficiency. Anyhow, the exact impact of DM1 on male fertility is unclear. OBJECTIVES To review the studies evaluating paternity rate, male gonadal axis, and semen parameters in men with DM1. MATERIALS AND METHODS A review of relevant literature from January 1980 to December 2020 was performed. Only studies published in English reporting data on fatherhood (rate of children by natural fertility), hormonal and seminal parameters were included. Out of 14 retrieved articles, the eight studies evaluating semen parameters were meta-analyzed. RESULTS The rate of children (four studies) was lower than controls among men affected by DM1, especially in men with a longer duration of disease. The data of gonadal hormonal profile in DM1 men (six studies) are very heterogeneous and a neutral effect of DM1 or a condition of subclinical hypogonadism could not be concluded. Meta-analysis showed that men with DM1 (n = 380), compared with controls (n = 434), have significantly lower normal sperm morphology [-0.36% (-0.66; -0.06), p < 0.05, six studies] and sperm progressive motility [33.62% (-39.13; -28.11), p < 0.001, two studies] and a trend toward a lower seminal volume [-0.51 (-1.03; 0.02), p = 0.06, eight studies], without difference in total sperm count and concentration. Data on scrotal ultrasound and sperm DNA fragmentation are too few. No study evaluated other factors of male infertility, such as transrectal ultrasound, semen infections, sperm auto-antibodies, and retrograde ejaculation. DISCUSSION DM1 might impair male fertility and testis functions (endocrine, spermatogenesis), but definition of its actual impact needs further studies. CONCLUSION Men with DM1 should be evaluated with a complete hormonal, seminal, and ultrasound workup to better define their fertility potential and need for follow up of testis functions.
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Consumption of ultra-processed foods and health status: a systematic review and meta-analysis.
Pagliai, G, Dinu, M, Madarena, MP, Bonaccio, M, Iacoviello, L, Sofi, F
The British journal of nutrition. 2021;125(3):308-318
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Ultra-processed foods (UPF) are, according to the NOVA classification, “formulations of ingredients, mostly for industrial use only, derived from a series of industrial processes”. UPF represents an important and growing part of the world’s food supply. The aim of this study was to assess the relationship between UPF consumption as defined by NOVA and health status. This study is systematic review with meta-analysis of all the cross-sectional and cohort studies published to-date. At the end of the selection process, twenty-three articles were included in the qualitative analysis and nineteen in the quantitative analysis. Results indicate the possible association between high UPF consumption, worse cardiometabolic risk profile (reported by an increased risk of overweight/obesity, elevated waist circumference, reduced high-density lipoprotein-cholesterol levels and increased risk of the metabolic syndrome), and greater risk of all-cause mortality, cardiovascular disease, cerebrovascular disease and depression. Authors conclude that their findings have important public health implications, especially for food policymakers who should discourage the consumption of UPF and promote fresh and minimally processed foods to improve health status.
Abstract
Increasing evidence suggests that high consumption of ultra-processed foods (UPF) is associated with an increase in non-communicable diseases, overweight and obesity. The present study systematically reviewed all observational studies that investigated the association between UPF consumption and health status. A comprehensive search of MEDLINE, Embase, Scopus, Web of Science and Google Scholar was conducted, and reference lists of included articles were checked. Only cross-sectional and prospective cohort studies were included. At the end of the selection process, twenty-three studies (ten cross-sectional and thirteen prospective cohort studies) were included in the systematic review. As regards the cross-sectional studies, the highest UPF consumption was associated with a significant increase in the risk of overweight/obesity (+39 %), high waist circumference (+39 %), low HDL-cholesterol levels (+102 %) and the metabolic syndrome (+79 %), while no significant associations with hypertension, hyperglycaemia or hypertriacylglycerolaemia were observed. For prospective cohort studies evaluating a total population of 183 491 participants followed for a period ranging from 3·5 to 19 years, highest UPF consumption was found to be associated with increased risk of all-cause mortality in five studies (risk ratio (RR) 1·25, 95 % CI 1·14, 1·37; P < 0·00001), increased risk of CVD in three studies (RR 1·29, 95 % CI 1·12, 1·48; P = 0·0003), cerebrovascular disease in two studies (RR 1·34, 95 % CI 1·07, 1·68; P = 0·01) and depression in two studies (RR 1·20, 95 % CI 1·03, 1·40; P = 0·02). In conclusion, increased UPF consumption was associated, although in a limited number of studies, with a worse cardiometabolic risk profile and a higher risk of CVD, cerebrovascular disease, depression and all-cause mortality.
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Association Between Prediabetes and Erectile Dysfunction: A Meta-Analysis.
Jin, M, Yuan, S, Wang, B, Yi, L, Wang, C
Frontiers in endocrinology. 2021;12:733434
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Erectile dysfunction (ED) is a common sexual dysfunction in men, which is defined as the failure to achieve or maintain an erection for satisfactory sexual intercourse. Besides aging, diabetes mellitus has also been recognised as a major risk factor for ED. The aim of this study was to systematically evaluate the association between prediabetes and ED. This study is a meta-analysis of nine observational studies, including five matched case-control studies and four cross-sectional studies. Results show that compared to men with normoglycemia, those with prediabetes were associated with higher prevalence of ED. Further subgroup analysis showed that mean age of the male participants in each study may affect the results as the association between prediabetes and ED seemed to be stronger in studies with younger men (mean age <50 years) than that in studies with older men (mean age ≥50 years). Authors conclude that prediabetes is associated with higher prevalence of ED, which may be independent of age of the males and may be stronger in young men.
Abstract
BACKGROUND Diabetes has been associated with the increased risk of erectile dysfunction (ED). However, previous studies evaluating the association between prediabetes and ED showed inconsistent results. We performed a meta-analysis of observational studies to systematically evaluate the above association. METHODS Relevant observational studies were retrieved by search of PubMed, Embase, and Web of Science databases. A random-effect model which incorporated the potential intra-study heterogeneity was used for the meta-analysis. Subgroup analyses were performed to evaluate the influences of study characteristics on the outcome. RESULTS Nine studies (five matched case-control studies and four cross-sectional studies) were included. Age were adjusted or matched in all of the studies. Pooled results showed that compared to men with normoglycemia, men with prediabetes were associated with higher prevalence of ED (odds ratio = 1.62, 95% confidence interval: 1.28 to 2.07, P < 0.001; I2 = 78%). Subgroup analyses showed that the association was not significantly affected by definition of prediabetes, diagnostic tool for ED, or controlling of additional variables besides age (both P for subgroup difference > 0.05). However, the association between prediabetes and ED seemed to be stronger in case-control studies than that in cross-sectional studies, and in studies with younger men (mean age < 50 years) than in those with older men (mean age ≥ 50 years; both P for subgroup difference < 0.05). CONCLUSIONS Prediabetes is associated with higher prevalence of ED, which may be independent of age of the males and may be stronger in young men.
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Food processing and cardiometabolic risk factors: a systematic review.
Santos, FSD, Dias, MDS, Mintem, GC, Oliveira, IO, Gigante, DP
Revista de saude publica. 2020;54:70
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Cardiovascular diseases (CVD) comprise the main cause of mortality in the world and approximately three quarters of deaths occur in low- and middle-income countries. The aim of this study was to assess the association between food consumption according to processing and cardiometabolic factors in adults and/or the elderly. This study is a systematic review of eleven studies. Five studies (46%) had a sample size greater than 10,000 participants and the smallest sample identified evaluated 302 individuals. Results indicate that the consumption of UPF can have an unfavourable impact on the health of individuals, especially contributing to increase the body mass index. The cardiometabolic risk factors identified were overweight or obesity, arterial hypertension and metabolic syndrome. Authors conclude that their findings may contribute to strengthening scientific evidence that underlies public policies related to the area of food and nutrition and the coping with cardiovascular diseases.
Abstract
OBJECTIVE To systematically review the evidence for the association between food consumption according to processing and cardiometabolic factors in adults and/or the elderly. METHOD Two independent evaluators analyzed the electronic databases PubMed, Web of Science and Lilacs until December 2018. We used the following terms: (convenience foods OR food processing OR highly-processed OR industrialized foods OR minimally-processed OR prepared foods OR processed foods OR ultra-processed OR ultraprocessed OR ultra processed OR unprocessed) AND (metabolic syndrome OR hypertension OR blood pressure OR diabetes mellitus OR glucose OR glycaemia OR insulin OR cholesterol OR triglycerides OR blood lipids OR overweight OR obesity) AND (adult OR adults OR adulthood OR aged OR elderly OR old). We assessed methodological and evidence qualities, and also extracted information for the qualitative synthesis from the selected studies. RESULTS Of the 6,423 studies identified after removing duplicates, eleven met the eligibility criteria. The main food classification we used was Nova. The consumption of ultra-processed foods was positively associated with overweight and obesity, high blood pressure and metabolic syndrome. All articles included met more than 50% of the methodological quality criteria. The quality of evidence was considered moderate for the outcome overweight and obesity and weak for hypertension and metabolic syndrome. CONCLUSIONS The Nova food classification stands out in the area of nutritional epidemiology when assessing the effects of food processing on health outcomes. Although caution is required in the interpretation, the results indicated that the consumption of ultra-processed foods can have an unfavorable impact in the health of individuals.
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Vitamin D and diabetic foot ulcer: a systematic review and meta-analysis.
Dai, J, Jiang, C, Chen, H, Chai, Y
Nutrition & diabetes. 2019;9(1):8
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The diabetic foot ulcer is a severe complication in patients with diabetes mellitus. The aim of the study was to assess the relationship between serum vitamin D levels with diabetic foot ulcer. The study is a review and metanalysis of seven cohort studies of which one was published in Russian. 115 patients were recruited for the study. The meta-analysis results indicate that patients with diabetic foot ulcer had significantly lower vitamin D levels compared to diabetic patients without foot ulcer. Authors conclude that severe vitamin D deficiency was associated with an increased risk of diabetic foot ulcer.
Abstract
We aimed to evaluate the association between vitamin D deficiency and diabetic foot ulcer (DFU) in patients with diabetes. Pubmed, EMBASE, BIOSIS, the Cochrane Library, and Web of Knowledge, last updated in July 2018, were searched. We assessed eligible studies for the association between vitamin D deficiency and DFU in diabetic patients. The mean difference (MD) or the odds ratio (OR) was calculated for continuous or dichotomous data respectively. Data were analyzed by using the Cochrane Collaboration's RevMan 5.0 software. Seven studies that involved 1115 patients were included in this study. There were significantly reduced vitamin D levels in DFU (MD -13.47 nmol/L, 95%CI -16.84 to -10.10; P = 0.34, I2 = 12%). Severe vitamin D deficiency was significantly associated with an increased risk of DFU (OR 3.22, 95%CI 2.42-4.28; P = 0.64, I2 = 0%). This is the first meta-analysis demonstrating the association between serum vitamin D levels and DFU. Severe vitamin D deficiency is significantly associated with an increased risk of DFU.
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Dietary Glycemic Index and Load and the Risk of Type 2 Diabetes: Assessment of Causal Relations.
Livesey, G, Taylor, R, Livesey, HF, Buyken, AE, Jenkins, DJA, Augustin, LSA, Sievenpiper, JL, Barclay, AW, Liu, S, Wolever, TMS, et al
Nutrients. 2019;11(6)
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It is generally accepted that certain diet and lifestyle choices contribute to a person’s risk of developing type 2 diabetes (T2D). In this meta-analysis, researchers set out to review previous studies and assess whether there is any evidence that the amount and type of carbohydrate (measured by Glycaemic Index (GI) and Glycaemic Load (GL)) in a person’s diet has a direct influence on their risk of developing T2D. The authors concluded with a high level of confidence that eating high GI and GL foods can lead to a higher risk of developing T2D. They suggest that nutrition advice that favours low GI and GL foods could produce significant cost savings for public healthcare.
Abstract
While dietary factors are important modifiable risk factors for type 2 diabetes (T2D), the causal role of carbohydrate quality in nutrition remains controversial. Dietary glycemic index (GI) and glycemic load (GL) have been examined in relation to the risk of T2D in multiple prospective cohort studies. Previous meta-analyses indicate significant relations but consideration of causality has been minimal. Here, the results of our recent meta-analyses of prospective cohort studies of 4 to 26-y follow-up are interpreted in the context of the nine Bradford-Hill criteria for causality, that is: (1) Strength of Association, (2) Consistency, (3) Specificity, (4) Temporality, (5) Biological Gradient, (6) Plausibility, (7) Experimental evidence, (8) Analogy, and (9) Coherence. These criteria necessitated referral to a body of literature wider than prospective cohort studies alone, especially in criteria 6 to 9. In this analysis, all nine of the Hill's criteria were met for GI and GL indicating that we can be confident of a role for GI and GL as causal factors contributing to incident T2D. In addition, neither dietary fiber nor cereal fiber nor wholegrain were found to be reliable or effective surrogate measures of GI or GL. Finally, our cost-benefit analysis suggests food and nutrition advice favors lower GI or GL and would produce significant potential cost savings in national healthcare budgets. The high confidence in causal associations for incident T2D is sufficient to consider inclusion of GI and GL in food and nutrient-based recommendations.
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Effect of Probiotics on Metabolic Outcomes in Pregnant Women with Gestational Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Taylor, BL, Woodfall, GE, Sheedy, KE, O'Riley, ML, Rainbow, KA, Bramwell, EL, Kellow, NJ
Nutrients. 2017;9(5)
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The gut microbiota is an important ecosystem consisting of both residential and pathogenic bacteria. The microbiota produce bioactive compounds shown to benefit host metabolism. A variety of factors influence the gut microbiome, including host genetics, illness, antibiotic use, dietary patterns, weight loss and pregnancy. Throughout pregnancy the gut microbiota undergoes significant changes. The aim of this study is to determine the effect of 6-8-week probiotic supplementation versus placebo on glucose homeostasis, lipid levels and gestational weight gain in pregnant women diagnosed with gestational diabetes mellitus. This study is a systemic review based on four randomised controlled trials involving 288 participants. All studies included healthy pregnant women, age range between 18 – 40 years, who were diagnosed with gestational diabetes mellitus at 24 – 30 weeks gestation by oral glucose tolerance test. The study found that a 6 – 8-week probiotic intervention did not improve fasting blood glucose or LDL-cholesterol levels. However, probiotic supplementation in women with gestational diabetes mellitus was associated with significant reductions in insulin resistance. Authors conclude that while probiotic supplementation resulted in a significant reduction in insulin resistance in pregnant women with gestational diabetes mellitus, there was no significant effect on fasting blood glucose or LDL-cholesterol.
Abstract
The metabolic effects of probiotic administration in women with gestational diabetes mellitus (GDM) is unknown. The objective of this review was to investigate the effect of probiotics on fasting plasma glucose (FPG), insulin resistance (HOMA-IR) and LDL-cholesterol levels in pregnant women diagnosed with GDM. Seven electronic databases were searched for RCTs published in English between 2001 and 2017 investigating the metabolic effects of a 6-8 week dietary probiotic intervention in pregnant women following diagnosis with GDM. Eligible studies were assessed for risk of bias and subjected to qualitative and quantitative synthesis using a random effects model meta-analyses. Four high quality RCTs involving 288 participants were included in the review. Probiotic supplementation was not effective in decreasing FBG (Mean Difference = -0.13; 95% CI -0.32, 0.06, p = 0.18) or LDL-cholesterol (-0.16; 95% CI -0.45, 0.13, p = 0.67) in women with GDM. However, a significant reduction in HOMA-IR was observed following probiotic supplementation (-0.69; 95% CI -1.24, -0.14, p = 0.01). There were no significant differences in gestational weight gain, delivery method or neonatal outcomes between experimental and control groups, and no adverse effects of the probiotics were reported. Probiotic supplementation for 6-8 weeks resulted in a significant reduction in insulin resistance in pregnant women diagnosed with GDM. The use of probiotic supplementation is promising as a potential therapy to assist in the metabolic management of GDM. Further high quality studies of longer duration are required to determine the safety, optimal dose and ideal bacterial composition of probiotics before their routine use can be recommended in this patient group.