Effect of Psyllium Supplementation on Insulin Resistance and Lipid Profile
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http://www.ijwhr.net doi 10.15296/ijwhr.2020.29 Open Access Original Article International Journal of Women’s Health and Reproduction Sciences Vol. 8, No. 2, April 2020, 184–191 ISSN 2330- 4456 Effect of Psyllium Supplementation on Insulin Resistance and Lipid Profile in Non-diabetic Women With Polycystic Ovary Syndrome: A Randomized Placebo-Controlled Trial Fatemeh Pourbehi1 ID , Parvin Ayremlou2, Alireza Mehdizadeh3, Rasoul Zarrin4* ID Abstract Objectives: Polycystic ovary syndrome (PCOS) is the most common cause of infertility in women. In addition, the risk of type- 2 diabetes mellitus (T2DM), hyperinsulinemia, and insulin resistance is higher among women with PCOS. Psyllium can reduce the levels of fasting blood sugar (FBS), insulin resistance, and lipid profile. Thus, the present study aimed to evaluate the effect of psyllium supplementation on insulin resistance and the lipid profile in non-diabetic women with PCOS. Materials and Methods: In this randomized double-blind placebo-controlled trial, 54 eligible non-diabetic women with PCOS aged 18-45 were recruited from an endocrinology clinic and divided into 2 groups based on their body mass index (BMI) through stratified-block randomization. Participants in intervention and placebo groups received 5 g of psyllium or cellulose microcrystalline twice a day for 8 weeks. Fasting insulin, FBS, and insulin resistance indicators including HOMA1-IR, HOMA2-IR, along with quantitative insulin sensitivity check index (QUICKI) and the lipid profile were evaluated before and after the intervention. Results: In the psyllium group, the FBS, fasting insulin, total cholesterol, low-density lipoprotein cholesterol (LDL-C), HOMA1-IR, and HOMA2-IR indicators decreased significantly (P < 0.05) after 8 weeks, but the changes were not significant in the placebo group. The mean changes in LDL-C (0.28±0.58 and 0.11±0.67 in intervention and placebo groups, respectively, P = 0.036) and QUICKI (0.01±0.03 and 0.02±0.06 in intervention and placebo groups, respectively, P = 0.044) were significant between the two groups from the baseline. Conclusions: Psyllium supplementation decreased FBS, fasting insulin, and the lipid profile while improving insulin resistance in non-diabetic women with PCOS. Keywords: Psyllium, Polycystic ovary syndrome, Insulin resistance, Lipid profile, Clinical trial Introduction mellitus (T2DM) in women with PCOS is 5 to 10 times Polycystic ovary syndrome (PCOS), as a common higher than healthy subjects (5). Studies indicate that metabolic-endocrine disorder, is the main cause of 70% of women with PCOS have abnormality at least in infertility in women (1,2). The prevalence of PCOS one part of their lipid profile because of the negative was reported 18% based on the Rotterdam criteria in effect of insulin resistance on the lipid profile (8). A study Australia (3). Women with POS often suffer from obesity, of women with PCOS showed that lifestyle changes and hyperandrogenism, and their effects such as hirsutism, metformin increase insulin resistance and the number acne, and alopecia (4). The pathophysiologic mechanism of menstrual cycles while decreasing body mass index of PCOS is unclear, but evidence shows reduced insulin (9). Today, the Rotterdam criteria are internationally sensitivity with hyperinsulinemia among 30%-80% of accepted for the diagnosis of PCOS (3). The angiotensin- these women (5). The production of androgen by the converting enzyme (ACE) gene has 3 polymorphisms, the ovaries and adrenal glands increases in the presence of deletion/deletion (DD) genotype of which causes its high hyperinsulinemia (5). In addition, PCOS are associated activity (10). In the ovarian, there is a renin-angiotensin with a high incidence of hypertension, dyslipidemia, system but its mechanism is unknown. In addition, it is heart disease, visceral obesity, glucose intolerance, insulin possible that the high blood pressure associated with the resistance, and hyperinsulinemia (6,7). The prevalence of DD genotype from the ACE gene can play a role in the the impaired oral glucose tolerance test in obese women occurrence of PCOS (10). with PCOS is approximately 20% (2). The risk of diabetes The husk or the seed of “Plantago ovata” or “Psyllium” Received 19 January 2018, Accepted 23 June 2018, Available online 18 July 2018 1Department of Nutrition, School of Medicine, Urmia University of Medical Sciences, Urmia, Iran. 2Clinical Research Development Unit of Imam Khomeini Hospital, Urmia University of Medical Sciences, Urmia, Iran. 3Department of Internal diseases, Urmia University of Medical Sciences, Urmia, Iran. 4Department of Nutrition, School of Medicine, Urmia University of Medical Sciences, Urmia, Iran. *Corresponding Author: Rasoul Zarrin, Tel: +989148843592, Fax: +984433457278, Email: [email protected] Pourbehi et al is considered as a bulking agent with 65%-75% total fiber not-diabetic individuals with a fasting blood sugar (FBS) (11,12). As a viscose fiber soluble in water, psyllium forms of less than 6.99 mmol/L (126 mg/dL). The diagnosis of a gel traditionally used in many countries such as India for PCOS according to the Rotterdam criteria was conducted the treatment of constipation and irritable bowel syndrome by an endocrinologist using a blood androgen test and (13-15). Psyllium was also used to treat conditions such ultrasound ovarian exam. Anyone with 2 of the three as diarrhea, inflammatory bowel disease, and ulcerative characteristics of the Rotterdam criteria (i.e., Oligo or colitis (16). As a fiber type, it is well-tolerated and safe for anovulation-clinical and/or the biochemical signs of human health (17). hyperandrogenism, and polycystic ovaries having 12 or Evidence demonstrates that psyllium can bind to the more follicles in size from 2 to 9 mm in diameter) was bile acids in the digestive tract after consumption and considered a PCO patient (7). The exclusion criteria inhibit the reabsorption of bile acids in the ileum (18). involved subjects who received glucose-lowering agents Therefore, psyllium can reduce cholesterol absorption except for metformin, anti-lipids, corticosteroids, and be effective in the treatment of mild to moderate antidepressants, lithium, warfarin, carbamazepine, and hypercholesterolemia (18). digoxin. Additionally, subjects with a history of heart, Further, psyllium can correct the insulin and blood liver, or gastrointestinal diseases, thyroid disorders, type- glucose levels in people with T2DM (19). However, there 1 and type-2 diabetes, gastrectomy, congenital adrenal are inconsistencies about high-fiber diets lowering blood hyperplasia, Cushing’s syndrome, hyperprolactinemia, sugar levels (20). and adrenal tumor secretion were excluded from the It is hypothesized that psyllium can reduce the blood study. Based on the mean ± standard deviation (SD) of glucose levels and lipid profiles while improving insulin 1-hour insulin in a previous study (24) with type I error resistance with its viscosity properties, gel formation, and (α) 5% and a power of 90%, along with a 20% drop out, changes in motility and absorption in the gastrointestinal the sample size was calculated 27 subjects in each group tract (14). by the following formula. 2 2 2 2 Considering the effect of glucose-lowering drugs in n= (Z1-α/2 + Z1-β) (S1 + S2 ) / (µ1-µ2) insulin resistance in diabetic patients, the present study included non-diabetic women with PCOS to evaluate Intervention the effect of psyllium on the glycemic and lipid profile The participants were divided into intervention and in non-diabetic patients with PCOS. Although several placebo groups using the stratified-block randomization studies in this area have focused on patients with T2DM, method based on their body mass index (BMI) levels no study has evaluated this effect in patients with PCOS. (BMI ˂18.49, 18.5˂BMI˂24.99, and 25 ˂BMI). The It is likely that hyperinsulinemia is responsible for most participants received 5 g psyllium (intervention group) PCO symptoms (21). Therefore, this study aimed to or microcrystalline cellulose (placebo group) twice a evaluate the effect of supplementation with the viscose day for 8 weeks. In addition, they were asked to solve the fiber of psyllium on blood glucose and insulin levels, as content of each psyllium or placebo sachets in 250 mL of well as lipid profiles and insulin resistance in non-diabetic water and then consume it 30 minutes before breakfast women with PCOS. and dinner twice a day. The dietary intake was evaluated using 3-day food records at weeks 1 and 7. The sachets Materials and Methods of psyllium and placebo were delivered biweekly and the Study Design patient’s compliance was assessed by checking the number This randomized, double-blind, parallel-group, placebo- of envelopes returned on each visit. controlled trial was conducted on non-diabetic women The body composition measures including height, with PCOS. The possible side effects of taking psyllium weight, BMI, fat mass (FM), fat-free mass (FFM), skeletal were explained to the patients, including stomach pain, muscle mass (SMM), and waist to hip ratio (WHR) were diarrhea, constipation, nausea, and headache (22). measured using a bioelectrical impedance analysis device However, psyllium is a laxative agent with good safety, (BIA) before and after the intervention (InBody 770-BIA). which has been used for many years (23). After explaining the study conditions, participants gave written informed Blood Sampling consent. Moreover, they were assured of the confidentiality FBS, insulin