Development and Formulation of Phytoestrogen-rich Supplement for Women with Polycystic Ovary Syndrome

INTRODUCTION

Polycystic ovary syndrome (PCOS) is an endocrine disorder with various health complications such as menstrual irregularities, insulin resistance, hyperandrogenism, hirsutism, acne, and obesity.¹ Genetic and lifestyle factors contributing to the etiology of PCOS have been evidenced by many research studies. However, its exact mechanism still remains unclear.² The impact of PCOS symptoms can affect the woman’s quality of life and result in psychological stress that frightens her feminine identity.³ Prevalence of PCOS among women of reproductive age (18–45 years) is 6–14%.⁴ Polycystic ovary syndrome can be diagnosed by confirming the Rotterdam criteria such as oligomenorrhea or anovulation, biochemical signs of hyperandrogenism, and polycystic ovaries in ultrasound sonography.⁵

Lifestyle behavioral changes like dietary behavior, physical exercise, and stress can also be one of the etiologies of PCOS. In Asia, the prevalence rate of overweight and obese and insulin resistance among PCOS subjects were stated as 61 and 44–70%.^6,7 Decreased weight management in PCOS can lead to psychological disturbances like depression, anxiety, body image disturbance, and disordered eating among women with PCOS.^8,9 Recent studies indicate that oxidative stress also leads to metabolic diseases, such as insulin resistance; hence, it can also be one of the causes of PCOS.¹⁰ Metformin, thiazolidinediones, and insulin-sensitizing agents are the medications used in the treatment of PCOS to decrease insulin resistance, androgen levels, inflammatory symptoms, and menstrual irregularity. On the other hand, many side-effects have been reported for these drugs such as nausea (61%), vomiting (30%), and diarrhea (65%).⁴ An assisted reproductive technology used to control the burden of infertility has a frequency of adverse events and costs high. Hence, this study was aimed to warrant the consideration of alternative novel dietary approaches to control infertility exclusively PCOS.

The novel dietary supplements were made out of underutilized ingredients such as Fenugreek seeds (Trigonella foenum-graecum), Flaxseeds (Linum usitatissimum), Black sesame seeds (Sesamum indicum), and Nicker nuts (Caesalpinia bonduc). The selection of ingredients was based on the following properties such as phytoestrogens, hypoglycemic effect, insulin stimulation activity, and anti-oxidants. Phytoestrogens are a nutritional component that mimics the structure and functions of estrogen. Phytoestrogens are a diverse group of non-steroidal compounds produced by plants. The major classes of phytoestrogens are the isoflavones and lignans.^11,12

AIM

To develop and evaluate novel dietary supplements for women with PCOS by using underutilized ingredients.

OBJECTIVES

• To provide an alternative novel dietary approach to treat PCOS.
• To develop and evaluate the novel dietary supplement by using underutilized ingredients.

ETHICAL AND HUMANE CONSIDERATIONS

Before conducting this study, approval from the scrutiny committee of the institution has been obtained. The developed supplement was approved by our Institutional Ethical Committee for clinical evaluation of drugs (IEC/19/AUG/15/54).

MATERIALS AND METHODS

The novel dietary supplements were developed by incorporation of underutilized ingredients which are locally available. Organoleptic evaluation and nutritional composition analysis were carried out for the developed supplements. Standardization has been done to explore whether the supplements containing the ingredients were palatable and acceptable or not. Three different dietary supplements were developed under proper standard and hygienic conditions.

RESULTS

The novel dietary supplements were developed with selected underutilized ingredients. The developed dietary supplements were evaluated for the organoleptic properties and nutrient composition. The results are given below.

DISCUSSION

The organoleptic evaluation of the developed supplements was graded by using a Hedonic scale 9 point such as like moderately (supplement 1) and like very much (supplement 3). Supplement 2 graded between neither like nor dislike and like slightly. Hence, the above-mentioned two supplements 1 and 2 were palatable and satisfactory for a regular diet on daily basis. Supplement 3 contains nutrients like omega-3 fatty acids, calcium, vitamin-A, polyphenols, and flavonoids in high amounts whereas moderate and trace amounts of selenium, protein, carbohydrate, fiber, iron, and vitamin-E. The nutrient composition of supplement 3 is given in Table 3 and Figure 3. Hence, it can be used for the treatment of polycystic ovarian syndrome and diabetes mellitus. The statistical analysis of the developed supplements given in the states that the developed dietary supplements were statistically significant (p < 0.05).

This study was performed to develop and evaluate novel dietary supplements for women with PCOS. The phyto-constituent presence in the used ingredients was known to stimulate insulin secretion, decrease blood glucose levels, and regulate menstrual irregularities. It contains a good amount of omega-3 fatty acid which is said to reduce the cholesterol and triglycerides level in blood. Formulated dietary supplements also rich in iron content; hence, it can be used for the treatment of anemia and menstrual irregularities. One of the researches done on sesame seeds exhibited that the intake of 60 g/day of sesame seeds for subjects with oligomenorrhea showed that 72% of the subjects who participated in that study have experienced proper menstrual bleeding and reduction in pain during menstruation after consumption of sesame seeds for 7 days.¹⁷ Hence, developed supplements could be used to regulate the menstrual cycle.

This study will be carrying out further by the intervention of the finalized supplement to the PCOS subjects. The study includes 120 subjects. Subjects will be recruited based on the inclusion and exclusion criteria of the study. The randomized control trial (RCT) study will contain two different groups of PCOS subject’s control (60) and the intervention group (60). Intervention group subjects will be asked to consume the intervention for a period of 60 days. Before and after intervention subjects dietary behavior, physical activity level, stress level, ovaries (transvaginal sonography) and biochemical parameters such as luteinizing hormone (LH), follicle-stimulating hormone (FSH), free testosterone, serum prolactin, and lipid profile, oral glucose tolerance test (OGTT), hemoglobin content will be diagnosed.

The limitations of this study are although past researches were conducted to study the effect of underutilized ingredients effect on PCOS, the depth of effect of the developed supplements will be identified after the intervention of the supplement to the PCOS subjects.

CONCLUSION

The novel dietary supplements that were developed with underutilized ingredients can provide health benefits to the subjects with PCOS such as regulation in menstrual irregularities, reduction in blood glucose level, reduction in blood cholesterol, and reduction in oxidative stress. It is an alternative approach to treat PCOS.

CLINICAL SIGNIFICANCE

The present study has got an impact on PCOS among reproductive-age women and an affordable underutilized novel dietary supplement will result in identifying:

• Improved ovulation
• Reduction in blood glucose level
• Weight loss
• Reduction in lipid levels
• Menstrual regularities
• Reduced oxidative stress
• Relieve from stress, depression, and anxiety.

ACKNOWLEDGMENTS

I would like to acknowledge my Research supervisor, Co-supervisor, and my Institution for their support and facilities for the development of supplements.

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