Hormonal imbalance due to physiologic deterioration of hypothalamic-pituitary-ovarian axis function may lead to a variety of symptoms
A recent clinical trial to investigate the safety and influence of Akay’s Fenusmart fenugreek extract on the hormonal balance of healthy young women demonstrated that the extract may help to ameliorate sexual issues such as low libido by improving vaginal dryness, irritability and mood.
The extract reportedly didn’t produce any side effects or adverse effects during the 42 days of study period when supplemented at 250 mg ×2/day. It offered significant benefits for sexual problems and irritability among those who had higher sexual dysfunctions scores.
The reproductive cycle is regulated by the hormones of the hypothalamic-pituitary-gonadal (HPG) axis; mainly the estradiol, progesterone, testosterone, follicle stimulating hormone (FSH), and luteinising hormone (LH). Hormonal imbalance due to physiologic deterioration of hypothalamic-pituitary-ovarian axis function may lead to a variety of symptoms such as hot flushes, sweating, sleep disturbance, mood swings, depression, cognitive decline, vaginal dryness and sexual dysfunction occur with a significant impact on their quality of life.
Since the currently available medications and modalities like hormone replacement therapy are associated with side effects, there is an interest in safe and natural agents to establish hormonal balance. Fenugreek (Trigonella foenum-graecum) may be the one medicinal herb that has been shown to be useful against various physiological issues of women; or for issues related to hormones, the company claims.
“So, we were eager to test the influence of Fenusmart on hormone balance and its safety in healthy young women,” said Mr Emmanuel, Chief Marketing Officer at Akay.
In the study, 48 healthy women aged 20-48 with regular menstrual cycles of 28–34 days were enrolled. Participants were randomised to two intervention arms to receive either Fenusmart or a placebo for 42 days at 250 mg twice a day. The study revealed a significant improvement in sexual problems (41.67%) and quality of life in treatment group when compared to placebo, with a 40% decrease in irritability score. Interestingly, an enhancement within normal reference range was observed for estradiol, total testosterones, and free testosterone among those who had low baseline levels; with no significant enhancement in progesterone and FSH.
However, the enhancement in estradiol and testosterone among participants with normal baseline levels was not significant, indicating relatively weak estrogenic activity for Fenusmart. Phytoestrogens are generally shown to possess weak binding with receptors. Under normal healthy conditions when there is enough natural estrogen in the body, the receptors available for binding with phytoestrogens will be limited. But, in the case of insufficient estrogen levels, phytoestrogens may bind to the receptors and support to ameliorate the symptoms associated with low estrogen levels, the company says.
“This is the most interesting and unique observation of the study that FENUSMART attenuates the reproductive hormones to establish a healthy hormonal balance, unlike the previous fenugreek extracts,” said Dr Krishnakumar, Chief Research Officer at Akay.
The molecular mechanism behind this hormonal balancing effect can be mainly attributed to the extract’s protodioscin content, Akay says. Protodioscin is a furostanolic saponin molecule that shares significant structural similarity with DHEA. It was shown that protodioscin can be converted to DHEA, which further gets converted to testosterone and estradiol. Aromatase is involved in the further conversion of testosterone to estradiol. Trigonelline, another major component in the ingredient, has also been proven to enhance the estrogen levels and work on serotonin pathway.
Fenusmart has 2 USA patents covering the process of manufacture, composition and its beneficial effect to alleviate post and peri-menopausal discomforts. It’s a hydro-ethanolic extract of fenugreek seeds containing protodioscin and trigonelline in a 3:1 ratio with around 10% of protodioscin along with other bioactive molecules in Fenugreek seeds such as 4-hydroxyisoleucine, Diosgenin and Flavonoids. The extract meets all regulatory regulations and is not an NDI or a novel food, the company says.
In another randomised double blinded study, the extract significantly ameliorated leg pain and vasomotor symptoms in postmenopausal women. Among peri-menopausal women, it also ameliorated vasomotor symptoms and depression.
Khanna et al. Clinical Phytoscience (2021) 7:63; Safety and influence of a novel extract of fenugreek on healthy young women: a randomized, double-blinded, placebocontrolled study