SCIENTIFIC EVIDENCE SUPPORTING THE EFFICACY OF HERBAL IGNITE FOR HIM MAX PRODUCT

EXECUTIVE SUMMARY

The natural ingredients in Intenza’s Herbal Ignite for Him Max product, described below, have a long history of traditional use and have demonstrated their safety and efficacy in human clinical trials. A brief summary of some of the highest-level evidence available for each ingredient is described below.

The key ingredients with the highest level of evidence from human clinical trials are:

• Tribulus which has been shown in multiple human clinical trials to support male sexual function and libido.
• Withania/Ashwaganda as the extract KSM66 which has been shown in multiple clinical trials to support male sexual and cognitive function as well as reducing the negative effects of stress.
• Pine Bark as Enzogenol which has been shown in clinical trials to support blood vessel health and blood flow.
• Saffron and polyphenolics in the form of the extract Enostim which has been shown in multiple human clinical studies to support male sexual function and libido.
• Additionally, the above key herbal ingredients are combined with the nutritional supplements zinc, selenium, vitamin D, and sulforaphane (from broccoli sprout) which have demonstrated benefits for supporting key cellular biochemical pathways that support testosterone metabolism and hormone balance.

 

FURTHER INGREDIENT INFORMATION

Tribulus Terrestris

Tribulus terrestris is a herb from the Ayurvedic tradition that is mostly recommended for male health including virility and vitality. It is commonly used for its libido enhancing properties. 

Tribulus has been shown in animal studies and in multiple human clinical trials to have efficacy for increasing testosterone and improving sexual/erectile function and libido/desire. Testosterone is also required for sperm production and can therefore affect fertility.

In a 2018 placebo controlled trial with 70 randomised aging male patients with erectile dysfunction, Tribulus was given daily for three months. Tribulus was found to have a statistically significant (P<0.001) effect on increasing Testosterone levels and improving erectile function as measured by the International index of erectile dysfunction (GamalEl Din et al., 2019).

In 2017 a randomised double blind placebo controlled trial was conducted to investigate a standardised Tribulus extract used daily for 12 weeks. The study included 180 males between the ages of 18 and 65 with mild to moderate erectile dysfunction. At the end of the 12 weeks, a statistically significant improvement was seen in multiple measures of sexual function, notably an improvement in erectile function measured by the international index of erectile dysfunction (P<0.0001)  as well as Intercourse satisfaction (P 0.0005) and sexual desire (P 0.0038) (Kamenov et al., 2017).

 

Withania/Ashwaganda KSM-66

Ashwagandha (Withania somnifera) is an herb used in Ayurvedic medicine, the traditional medicine of India. Its root has a horsey smell (in Sanskrit, ashva means “horse” and gandha means “smell”) and is said to confer the strength and virility of a horse. Various parts of the plant are used, but the most common in supplements is an extract of its roots.

KSM-66 is a branded and clinically trialled extract of Ashwaganda and is considered the “worlds best Ashwaganda”

(1) KSM-66 has the highest concentration of all major full-spectrum root extracts available on the market today. In a recent study, it was found to have the highest bioavailability.

(2) KSM-66 has the most extensive set of research studies and clinical trials. We have 24 studies: 12 published studies, 6 additional studies completed and in peer review and 6 ongoing studies.

KSM-66 Ashwagandha has been shown in clinical trials to:

(1) Reduce stress, anxiety, cortisol levels, and stress-related food cravings (Chandrasekhar et al., 2012)
(2) Enhance memory and cognition (Choudhary et al., 2017)
(3) Increase endurance, strength, muscle size and muscle recovery rate (Wankhede et al., 2015)
(4) Improve sexual function and testosterone (Ambiye et al., 2013)

 

Zinc Gluconate

Zinc gluconate is a bioavailable form of the mineral zinc. Zinc is an essential mineral involved in many biochemical reactions in the body. It is most known for it’s role in supporting a proper functioning immune system but is also required for optimal testosterone production and metabolism and low levels of testosterone have been found in cases of zinc deficiency (Baltaci et al., 2019).

 

 

Enzogenol – Pine Bark Extract

Enzogenol is a New Zealand made pine bark extract that has been clinically trialled for a number of health effects. Enzogenol has been shown to enhance blood vessel health and blood flow by increasing levels of Nitric Oxide which enhances vasodilation (Young et al., 2006).  Pine Bark extract in the form of pycnogenol has been clinically trialled in combination with L-arginine for erectile dysfunction in multiple studies. In the most recent study 12 subjects took 60mg of pine bark per day for 8 weeks. At the end of the 8 weeks 67% of the subjects experienced an improvement in the International Index of Erectile Dysfunction vs 36% in the placebo group and this effect was statistically significant with regard to erection hardness and sexual satisfaction (Aoki et al., 2012).

 

Enostim

Enostim is an innovative combination of polyphenols from grapes and apples and a saffron extract. Enostim itself has been shown to improve blood flow through increasing Nitric Oxide. Saffron as a separate component of Enostim has been used in multiple clinical trials that have been subjected to systematic review and meta-analysis. One paper focused on erectile function whilst the other focused on saffron’s effects on sexual dysfunction more broadly. Both reviews found positive conclusions with saffron showing beneficial effects on erectile dysfunction, libido, and sexual satisfaction (Maleki-Saghooni et al., 2018) (Ranjbar & Ashrafizaveh, 2019).  

 

Selenium

A vital micronutrient that many people in NZ and Australia are deficient in. Selenium is required for many biochemical reactions including testosterone metabolism and thyroid hormone production. It therefore has an impact on fertility and energy levels (Rayman, 2012).

 

Black Pepper

Black pepper has been shown to enhance the absorption and bioavailability of herbal constituents that otherwise are difficult for the body to absorb. Black pepper contains the active ingredient Piperene which is responsible for its effects (Han, 2011).  

 

Vitamin D

Vitamin D is an essential pro-hormone that is lacking in many people that supports mood, immunity and general health. Emerging evidence from epidemiological studies has shown a link between low vitamin D levels and both erectile dysfunction and low testosterone levels (Canguven & Al Malki, 2021).

 

Broccoli Sprout

Broccoli sprout powder is a source of sulphoraphane which induces the NRF2 transcription factor. Inducing NRF2 has wide ranging benefits for health including enhancing cellular antioxidant defences and supporting healthy detoxification which can help male hormone balance through the detoxification of oestrogens (Houghton, 2019)

 

REFERENCES

• Ambiye, V. R., Langade, D., Dongre, S., Aptikar, P., Kulkarni, M., & Dongre, A. (2013). Clinical Evaluation of the Spermatogenic Activity of the Root Extract of Ashwagandha  (Withania somnifera) in Oligospermic Males: A Pilot Study. Evidence-Based Complementary and Alternative Medicine : ECAM, 2013, 571420. https://doi.org/10.1155/2013/571420
• Aoki, H., Nagao, J., Ueda, T., Strong, J. M., Schonlau, F., Yu-Jing, S., Lu, Y., & Horie, S. (2012). Clinical assessment of a supplement of Pycnogenol® and L-arginine in Japanese  patients with mild to moderate erectile dysfunction. Phytotherapy Research : PTR, 26(2), 204–207. https://doi.org/10.1002/ptr.3462
• Baltaci, A. K., Mogulkoc, R., & Baltaci, S. B. (2019). Review: The role of zinc in the endocrine system. Pakistan Journal of Pharmaceutical Sciences, 32(1), 231–239.
• Canguven, O., & Al Malki, A. H. (2021). Vitamin D and Male Erectile Function: An Updated Review. The World Journal of Men’s Health, 39(1), 31–37. https://doi.org/10.5534/wjmh.190151
• Chandrasekhar, K., Kapoor, J., & Anishetty, S. (2012). A prospective, randomized double-blind, placebo-controlled study of safety and  efficacy of a high-concentration full-spectrum extract of ashwagandha root in reducing stress and anxiety in adults. Indian Journal of Psychological Medicine, 34(3), 255–262. https://doi.org/10.4103/0253-7176.106022
• Choudhary, D., Bhattacharyya, S., & Bose, S. (2017). Efficacy and Safety of Ashwagandha (Withania somnifera (L.) Dunal) Root Extract in  Improving Memory and Cognitive Functions. Journal of Dietary Supplements, 14(6), 599–612. https://doi.org/10.1080/19390211.2017.1284970
• GamalEl Din, S. F., Abdel Salam, M. A., Mohamed, M. S., Ahmed, A. R., Motawaa, A. T., Saadeldin, O. A., & Elnabarway, R. R. (2019). Tribulus terrestris versus placebo in the treatment of erectile dysfunction and  lower urinary tract symptoms in patients with late-onset hypogonadism: A placebo-controlled study. Urologia, 86(2), 74–78. https://doi.org/10.1177/0391560318802160
• Han, H.-K. (2011). The effects of black pepper on the intestinal absorption and hepatic metabolism of  drugs. Expert Opinion on Drug Metabolism & Toxicology, 7(6), 721–729. https://doi.org/10.1517/17425255.2011.570332
• Houghton, C. A. (2019). Sulforaphane: Its “Coming of Age” as a Clinically Relevant Nutraceutical in the Prevention and Treatment of Chronic Disease. Oxidative Medicine and Cellular Longevity, 2019, 2716870. https://doi.org/10.1155/2019/2716870
• Kamenov, Z., Fileva, S., Kalinov, K., & Jannini, E. A. (2017). Evaluation of the efficacy and safety of Tribulus terrestris in male sexual  dysfunction-A prospective, randomized, double-blind, placebo-controlled clinical trial. Maturitas, 99, 20–26. https://doi.org/10.1016/j.maturitas.2017.01.011
• Maleki-Saghooni, N., Mirzaeii, K., Hosseinzadeh, H., Sadeghi, R., & Irani, M. (2018). A systematic review and meta-analysis of clinical trials on saffron (Crocus sativus)  effectiveness and safety on erectile dysfunction and semen parameters. Avicenna Journal of Phytomedicine, 8(3), 198–209.
• Ranjbar, H., & Ashrafizaveh, A. (2019). Effects of saffron (Crocus sativus) on sexual dysfunction among men and women: A systematic review and meta-analysis. Avicenna Journal of Phytomedicine, 9(5), 419–427. https://pubmed.ncbi.nlm.nih.gov/31516855
• Rayman, M. P. (2012). Selenium and human health. Lancet (London, England), 379(9822), 1256–1268. https://doi.org/10.1016/S0140-6736(11)61452-9
• Wankhede, S., Langade, D., Joshi, K., Sinha, S. R., & Bhattacharyya, S. (2015). Examining the effect of Withania somnifera supplementation on muscle strength and  recovery: a randomized controlled trial. Journal of the International Society of Sports Nutrition, 12, 43. https://doi.org/10.1186/s12970-015-0104-9
• Young, J. M., Shand, B. I., McGregor, P. M., Scott, R. S., & Frampton, C. M. (2006). Comparative effects of enzogenol and vitamin C supplementation versus vitamin C  alone on endothelial function and biochemical markers of oxidative stress and inflammation in chronic smokers. Free Radical Research, 40(1), 85–94. https://doi.org/10.1080/10715760500329788