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Esmaeilinezhad Z, Babajafari S, Sohrabi Z, Eskandari M, Amooee S, Barati-Boldaji R. Effect of synbiotic pomegranate juice on blood glucose, sex hormone profile and anthropometric indices in PCOS: a randomized, triple-blind, controlled trial. (Link removed). 2018;29(2):201-208.
Study objective
To determine whether a synbiotic pomegranate drink improves insulin resistance in women with polycystic ovary syndrome (PCOS); a secondary objective was to assess changes in serum sex hormone levels and anthropometric measurements.
Draft
Randomized, triple-blind, placebo-controlled parallel study
Participant
Participants were recruited from Motahari Clinic in Shiraz, Iran, between January 2017 and July 2017; 92 women aged 15 to 48 met diagnostic criteria for PCOS and 86 completed the study. The Rotterdam criteria for PCOS are met when 2 or more of the following features are present and other possible causes have been ruled out: 1) oligo- or anovulation; 2) clinical or laboratory findings of hyperandrogenism; 3) multiple ovarian cysts observed on ultrasound.
Women were excluded from the study if they were smokers, breast-feeding, had a serious illness (including autoimmunity and significant organ dysfunction), or were receiving certain interventions (including chemotherapy, corticosteroids, antibiotics, hormones, and additional vitamins, minerals, or antioxidants). . The researchers also excluded people with “specific diets and physical activity,” but did not elaborate on this statement.
intervention
Participants were randomized into 4 study groups delineated by the intervention received: synbiotic pomegranate juice (SPJ); synbiotic drink (SB); pomegranate juice (PJ); and placebo (control).
The synbiotic pomegranate drink consisted of pomegranate juice, inulin (20 g/L) and equal parts of 3 types of bacteria:Lactobacillus rhamnosusGG,Bacillus coagulansandBacillus indicus(108Colony forming units [CFU]/g/L). The synbiotic drink had the same concentration of inulin and lactobacilli, but was water-based plus pomegranate flavor. The drinks were freshly prepared weekly during the experiment. The placebo drink was water plus pomegranate flavoring, and the pomegranate drink was pure juice. Participants consumed 2 liters of their drink per week for 8 weeks.
Study parameters assessed
Researchers measured fasting blood levels of insulin, glucose, total testosterone, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) at baseline and after 8 weeks. Using fasting glucose and insulin, they calculated the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and the Quantitative Insulin Sensitivity Check Index (QUICKI). They also completed 3-day diet recalls and measured BMI, waist circumference, and hip circumference at baseline and after 8 weeks.
Primary outcome measures
The study's primary outcome measure is insulin resistance, measured using HOMA-IR. Secondary endpoints were blood glucose, insulin, total testosterone, LH and FSH.
Key insights
Statistical analysis was performed using intergroup parameters, with the control group serving as the comparison group. A statistically significant reduction in insulin resistance (HOMA-IR) was observed in the SPJ and SB groups from baseline to 8 weeks (P<0.05).
Similarly, insulin sensitivity (as assessed by the QUICKI score) increased significantly in these 2 groups compared to the control group (P<0.05). This reflected the reduction in fasting insulin and glucose in these groups, but the reduction in fasting insulin was statistically significant only in the SB group.
The researchers hypothesized that these different mechanisms would produce synergistic effects when combined; However, no major improvement was observed in the synbiotic + pomegranate juice group over the SB group, except for waist-hip circumference.
Regarding the anthropometric changes, BMI, weight and waist circumference significantly decreased in the SPJ and SB groups (P<0.05). There was no significant change in hip circumference, but the waist-to-hip ratio decreased in the SPJ group. Total testosterone fell in the SPJ and SB groups (P<0.05), but there was no significant change in FSH or LH.
Practice implications
Synbiotics are believed to be beneficial for PCOS because of their effects on carbohydrate metabolism, insulin sensitivity and inflammation. These effects are achieved through increased production of glucagon-like peptide-1 (GLP-1), short-chain fatty acids (SCFAs) and natural killer cells.1.2Pomegranate juice (particularly its punicin and catalpic acid components) is also thought to improve insulin sensitivity and reduce inflammation, but through other mechanisms, including upregulation of peroxisome proliferator-activated receptor gamma (PPAR-γ) and reduction of tumor necrosis factor alpha (TNF-). α).3
The researchers hypothesized that these different mechanisms would produce synergistic effects when combined; However, no major improvement was observed in the synbiotic + pomegranate juice group over the SB group, except for waist-hip circumference. The authors attribute the lack of improvement to the short study duration and suggest that a longer study would reveal differences between these interventions. However, the pomegranate juice (PJ) group saw no improvements in any of the outcome measures assessed, and it appears inadvisable to place a person with insulin resistance on a regimen that - according to the United States Department of Agriculture (USDA) - adds an estimated 279g of carbohydrates (269g of sugar) to their weekly macronutrient intake, with no clear data available demonstrate independent benefit.
Would insulin resistance continue to improve with long-term use? It is a question worth asking in future research.
When pomegranate juice is removed from the equation, the question arises: Is there a benefit to administering synbiotics via drinks rather than capsules? The latter offers easy and consistent dosing and potentially better delivery of organisms to the colon when enteric coated. However, obtaining adequate amounts of inulin would likely require the addition of a powdered supplement. A recent meta-analysis and systematic review of probiotics and synbiotics in PCOS found only negligible benefits of these supplements on metabolic metrics.4while another systematic review found significant improvement in metabolic metrics and testosterone, but no anthropometric measurements.5The confusion could be due to the variability in the composition and effectiveness of the probiotics/synbiotics studied. One study that showed benefits for HOMA-IR and other metabolic parameters used a synbiotic withLactobacillus acidophilus,L casei,Bifidobacterium bifidumand inulin at a concentration of 2 billion CFU or 800 mg.6Another study that found benefits for apelin-36 (a peptide with effects on metabolic and cardiovascular health), but not HOMA-IR or inflammatory markers, used a mixL acidophilus,L casei,L. bulgaricus,L rhamnosus,B long,B abbreviatedandStreptococcus thermophiluswith inulin.7
The reduction in serum testosterone in the SPJ and SB groups is an intriguing secondary finding of this study. Further research is warranted to determine whether this reduction results in improvement in symptoms of hyperandrogenism, including acne, hirsutism, and oligo/anovulation. A study on a synbiotic containingL acidophilus,L casei,B bifidum(2 billion CFU) and inulin (800 mg), in addition to sex hormone and inflammatory markers, showed a reduction in the modified Ferriman-Gallwey score for hirsutism.8
Given the growing body of research showing the benefits of probiotics and synbiotics in a variety of conditions and a minimal risk of side effects, a 12-week trial of synbiotics with inulin and a mix is worth itLactobacilliandBifidobacteriumTypes of PCOS. Potential benefits include improvement in insulin resistance, BMI, waist circumference, and symptoms of hyperandrogenism. Based on the existing research, there is no compelling reason to combine synbiotics with pomegranate juice in the treatment of PCOS.