International Journal of Infertility and Fetal Medicine
Volume 12 | Issue 2 | Year 2021

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

Gayathri Kalidoss1, Supriya Velraja2, Palaniappan Narayanan3

1,2Department of Clinical Nutrition, Sri Ramachandra Faculty of Allied Health Sciences, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Chennai, Tamil Nadu, India
3Department of Obstetrics and Gynecology, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Chennai, Tamil Nadu, India

Corresponding Author: Supriya Velraja, Department of Clinical Nutrition, Sri Ramachandra Faculty of Allied Health Sciences, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Chennai, Tamil Nadu, India, Phone: +91 9841273715, e-mail: supriya.v@sriramachandra.edu.in

How to cite this article Kalidoss G, Velraja S, Narayanan P. Development and Formulation of Phytoestrogen-rich Supplement for Women with Polycystic Ovary Syndrome. Int J Infertil Fetal Med 2021;12(2):31–36.

Source of support: Nil

Conflict of interest: None


Background: Polycystic ovary syndrome (PCOS) is an endocrine disorder with various health complications like menstrual irregularities, hirsutism, acne, obesity, and insulin resistance. It is becoming a prominent cause of infertility among women worldwide. A woman’s diet may ultimately affect her fertility, particularly ovulation. The assisted reproductive technologies for the treatment of infertility may cost high and have an adverse effect. To reduce the adverse effects, the novel dietary supplements are the new alternative approach to treat PCOS. Novel dietary supplements enriched with phytoestrogen help in alleviating the symptoms of PCOS such as improvement in ovulation, reduced blood glucose level, reduced stress level, and decreased weight. The present study was aimed to develop novel dietary supplements for women with PCOS.

Aim and objective: To develop novel dietary supplements for women with PCOS by using underutilized ingredients.

Materials and methods: Three different types of novel dietary supplements (supplement 1, supplement 2, and supplement 3) were developed under proper hygienic conditions. The organoleptic properties of the developed supplements were evaluated by the group of panel members. Followed by organoleptic evaluation, nutrient compositions were analyzed for the finalized supplement (supplement 3).

Results: The nutrient composition of the finalized supplement was analyzed by using the standard procedure of AOAC (2016) and it is reported that the supplement is enriched with omega-3-fatty acid, polyphenols, flavonoids, selenium, iron, vitamin-A, and fiber. One-way ANOVA was used to analyze the significance between the formulated supplements and reported that the formulated supplements were statistically significant (p < 0.05).

Conclusion: The study signifies that novel dietary supplements rich in phytoestrogens like polyphenols and flavonoids can be used for the treatment of PCOS.

Clinical significance: Intake of developed supplement could result in regulation of menstruation and improvement in ovulation.

Keywords: Dietary supplements, Ingredients, Phytoestrogen, Polyphenols and flavonoids..


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

Fenugreek Seeds (Trigonella foenum-graecum)

A study conducted by Shailajan et al. reported that the intake of fenugreek seeds has not been stated to trigger any toxicological effects. The fenugreek seeds have been reported to have anti-diabetic and hypocholesterolemic effects in both animal models and humans. Phytoestrogens like isoflavonoids, lignin, coumestrol, and quercetin present in fenugreek seed are found to have anti-malarial, anti-diabetic, and galactagogue activity.13

Flaxseeds (Linum usitatissimum)

Flaxseeds contain phytoactive compounds like phenolic compounds, terpenoids, pigments, and other natural antioxidants.14 Study conducted by Jelodar et al. among 31-year-old woman with PCOS has exhibited that reduced testosterone and increased insulin level by the treatment with flaxseed (30 g/day for 4 months).15

Sesame Seeds (Sesamum indicum)

In traditional Persian medicine, sesame seeds have been used to increase libido and for the treatment of menstrual irregularities, renal and pulmonary diseases. In ancient medicine, sesame has been reported as a useful remedy for oligomenorrhea treatment, fetus abortion, raising the sexual tendency, and sperm count. Sesame seed contains flavonoids and phenolics.16,17

Nicker Nuts (Caesalpinia bonduc)

Nicker nuts have a lithotriptic action which aids to remove cysts from the ovary. A study demonstrated by Nazeerullah et al. reported that the nicker nuts powder was mixed with an equivalent part of pepper powder and given to malarial patients and was discovered to hold weak antiperiodic properties. Nicker nuts contain terpenoids, caesalpin, β-caesalpin, and α-caesalpin. In West Indies, the roasted seeds are used as an anti-diabetic medicine.1820 Hence, in this study, phytoestrogen-rich supplements was developed for women with PCOS and formulated by using the ingredients Trigonella foenum-graecum (Fenugreek seeds), Linum usitatissimum (Flaxseeds), Sesamum indicum (Sesame seeds), and Caesalpinia bonduc (Nicker nuts) as major ingredients to reduce side effects.

In this study, the novel dietary supplements have been designed based on literature review from research studies conducted in the past. The developed supplements could be used not only for regulating the menstrual cycle but also in regulating the blood glucose, cholesterol, and triglycerides levels, to increase hemoglobin content in blood, to reduce oxidative stress, and to reduce weight. The novel dietary supplements were developed to reduce the side effects and to discover the alternative approach to treat PCOS.


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



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).


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.

Phase-I: Preparation of Supplements

Underutilized ingredients such as Trigonella foenum-graecum, Linum usitatissimum, Sesamum indicum, and Caesalpinia bonduc were collected with the help of a botanist. The novel dietary supplements were prepared on the college campus at the food science lab, Department of Clinical Nutrition, SRIHER, Chennai. Three different types of dietary supplements were developed namely:

  • Supplement 1.
  • Supplement 2.
  • Supplement 3.

Phase-II: Organoleptic Evaluation

Organoleptic evaluation involves the inspection of a food product by five senses such as appearance, taste, flavor, color, and texture. To explore the quality of food the judgment of the recipes was made by the panel of judges during sensory evaluation given in Figure 1. The panel of sensory evaluators consists of 30 members. Organoleptic evaluation scores of the developed dietary supplements were done based on a Hedonic scale (9).

The supplements were evaluated for:

  • Appearance.
  • Taste.
  • Flavor.
  • Color.
  • Texture.
  • Overall acceptability.

The scorecard used in this study was Hedonic 9-point scale according to the standard procedures.21 The scorecards were given to the sensory evaluators to evaluate the developed dietary supplements.

Points are taken into consideration:

  • Evaluators were asked to give an unbiased opinion.
  • Evaluators were provided with a glass of water after each supplement.

Fig. 1: Organoleptic evaluation of developed supplements by sensory evaluators

Table 1: Different scores used in Hedonic 9-point scale
Dislike extremelyI
Dislike very muchII
Dislike moderatelyIII
Dislike slightlyIV
Neither like nor dislikeV
Like slightlyVI
Like moderately VII
Like very muchVIII
Like extremely IX

The different scores used in the Hedonic scale were given in Table 1. Followed by organoleptic evaluation, the finalized supplement has been given for nutrient analysis to analyze the nutrients composition.

Phase-III: Nutrient Analysis

Nutrient analysis of the finalized supplement was analyzed by using the standard procedure of AOAC (2016). High-performance liquid chromatography (HPLC) methods have been used in the analysis of nutrients.

Phase-IV: Statistical analysis

One-way ANOVA was used to measure the significant difference between the formulated dietary supplements by using SPSS software version 21. The mean and standard deviation were also calculated to find out the average and deviation within the data.


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.

Sensory Evaluation

Table 2 and Figure 2 show the average score of organoleptic evaluation of novel dietary supplements.

Supplement 1

The appearance (6.6), color (6.5), flavor (6.3), texture (7), and overall acceptability (6.7) were graded between like slightly and like moderately whereas taste (5.4) was rated as neither like nor dislike.

Supplement 2

The appearance (7), color (6.8), flavor (6), and texture (6.9) were graded between like slightly and like moderately whereas taste (5.6) and overall acceptability (5.5) rated between neither like nor dislike and like slightly.

Supplement 3

The appearance (7.6), taste (7.7), flavor (7.7), color (7.8), texture (8.1), and overall acceptability (7.8) were graded between like moderately and like very much.

Nutrient Analysis

The finalized novel supplement has been sent for nutrient analysis. Table 3 and Figure 3 exhibit that supplement 3 was energy-dense, rich in omega-3 fatty acid, calcium, vitamin-A, polyphenols, and flavonoids. A moderate amount of selenium, protein, and carbohydrate was presented. Fiber and iron were also found. A trace amount of moisture and vitamin-E was analyzed from the nutrient analysis.

The nutrient requirements vary for different age groups. The Recommended Dietary Allowances 2010 (RDA) suggested by the Indian Council of Medical Research (ICMR) for adult women has been compared. In this study, the nutrient content of the finalized supplement was compared with RDA for adult women has been given in Table 4 and Figure 4

Statistical Analysis

The mean ± SD of supplement 1, 2 and 3 were 38.5 ± 0.55, 37.8 ± 0.68 and 46.7 ± 0.17. ANOVA reported that its statistically significant (p < 0.05).


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).

Table 2: Average score of sensory evaluation of recipes
RecipeAppearance (9)Taste (9)Flavor (9)Color (9)Texture (9)Overall acceptability (9)
Nutritious laddoo (type-A)
Nutritious laddoo (type-B)75.666.86.95.5
Nutritious powder7.

Fig. 2: Average score of organoleptic evaluation of developed supplements

Table 3: Nutrient composition of nutritious powder (30 g)
S. no.ParametersMethodUnitsResults
  2CarbohydrateAOAC 20th Edn. 2016 986.25g/g17.15
  3ProteinIS 7219:1973 RA.2010g/30 g6.74
  4FatAOAC 20th Edn. 2016 920.85g/30 g3.45
  5FiberFSSAI Manual-Spices and condimentsg/30 g1.29
  6MoistureIS 10226g/30 g0.92
  7Omega-3-fatty acidAOAC 973.26 20th Edn. 2016mg/30 g65.1
  8Vitamin-AAOAC 974.29 20th Edn. 2016IU/30 g115.8
  9Vitamin-EAOAC 948.26 20th Edn. 2016mg/30 g0.72
10PolyphenolsAOAC 965.31 20th Edn. 2016mg/30 g36.9
11FlavonoidsAOAC 2012.24 20th Edn. 2016mg/30 g16.8
12IronAOAC 999.10 20th Edn. 2016mg/30 g1.77
13CalciumAOAC 944.03 20th Edn. 2016mg/30 g110
14SeleniumAOAC 986.15 20th Edn. 2016mg/30 g0.29

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.

Fig. 3: Nutrient composition of supplement 3 (30 g)

Fig. 4: Nutrients requirements met by nutritious powder as per RDA

Table 4: Comparison of nutrients content of nutritious powder and RDA for adult women
NutrientsRDANutritious powderPercentage meets RDA For 100 g (%)Percentage meets RDA for 30 g (%)
Energy1,900 kcal/day422.06 kcal/100 g22.216.66
Protein1 g/kg body weight/day22.47 g/100 g40.8 for 55 kg b.w.12.25
Fat20 g/day11.5 g/100 g57.517.25
Vitamin-A4,800 μg/day69 μg/100 g1.440.43
Calcium600 mg/day360 mg/100 g6018.3
Iron21 mg/day5.9 mg/100 g28.098.42

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.


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.


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


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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