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Delivering validated mood and sleep ingredients to help a stressed and anxious world

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The world needs better mood and sleep aids. Consumers are relying on the same old set of limited ingredients to manage mood and sleep at a time of unprecedented stress and anxiety. The inability of existing dietary supplements to rise to the challenge is causing a range of problems, from reduced productivity to weakened immune health. Gencor has responded to the unmet need by creating a portfolio of validated, differentiated mood and sleep ingredients.

Sleep plays a critical role in immune system homeostasis.1​ Researchers are still elucidating all of the mechanisms but the consequences of failing to get enough sleep on the immune system and overall health are already clear.

Total sleep deprivation is fatal to rodents, which die with signs of immune dysfunction such as splenic atrophy.2​ In humans, habitually sleeping fewer than six hours a night is statistically associated with a shorter life span, greater vulnerability to viral infection and reduced immune response to vaccines.3–5​ The evidence all points to a link between sleep and resilience against infection.

Consumers know they need to get more high-quality sleep. Almost half of adults in Asia Pacific are dissatisfied with their sleep.6​ The COVID-19 pandemic exacerbated the situation. Seventy percent of people said they experienced one or more new sleep challenges after the pandemic began.7​ Stress is the top barrier to a good night’s sleep and half of people said COVID-19 caused them stress.

The data illuminate links between mood, sleep and immunity. Stress, anxiety and other mood issues stop people from getting the recommended amount of good-quality sleep. In turn, a lack of sleep is linked to poor immune health.

Through that mechanism, worry about COVID-19 and other causes of stress and anxiety could make people more vulnerable to pathogens at a time when many consumers are trying to strengthen their immune systems. More than 75% of people in countries in Asia Pacific responded to the pandemic by trying to boost their immunity.8

The scientific and survey data point to strong consumer demand for products that can alleviate stress, improve sleep and, in doing so, potentially bolster immune health. However, the mood and sleep market has suffered from a lack of innovation.

Valerian is well established as a sleep aid but negatively affects judgment and focus, restricting when it can be taken. Melatonin is free from the limitations of valerian but is a long-term solution, not a fast-acting fix for a sleepless night, and is classed as a drug in some markets. Cannabidiol (CBD) is also treated as a drug in some markets and is linked with a range of adverse events and quality issues.9,10

Building a mood and sleep portfolio

Gencor responded to the lack of novelty in the mood and sleep market by working to develop superior, clinically proven products. The result is a portfolio of three ingredients with the potential to improve mood and sleep when used as single agents and in combination products.

One of the products, Levagen+, is a formulation of simple fatty acid amide palmitoylethanolamide (PEA) that uses a delivery technology to improve bioavailability. Gencor, an award-winning provider of herbal ingredients, validated the sleep application of PEA by running a double blind, randomized, placebo-controlled clinical trial that linked Levagen+ to a reduction in time to the onset of sleep.

The mechanism of action of Levagen+, part of the extended endocannabinoid family, is potentially complementary to that of another Gencor branded ingredient: CALMaluma. Gencor has sold the extract of the Caralluma fimbriata succulent as a weight management product for years, generating a body of evidence on its effect and safety.

Evidence of the effect of the extract on mood emerged after a researcher studied it in patients with Prader-Willi syndrome, a condition associated with excessive eating.11​ The trial detected a reduction in the abnormally strong sensation of hunger in the cohort of patients who took the extract, as well as a significant decline in the temper tantrums associated with the condition.

Evidence of the effect of the extract on mood led to a randomized, placebo-controlled clinical trial that looked at anxiety and stress.12​ Levels of stress, frustration and anxiety fell in the treatment group, while positive experience of emotion, which helps with relaxation, increased.

In CALMaluma and Levagen+, Gencor has two premium, differentiated and efficacious ingredients for the mood and sleep market. Yet, recognizing that mood and sleep issues are multifactorial, Gencor continued to look for complementary ingredients that could help bring relief to more consumers. The search led Gencor to lavender oil.

The oil is widely used as a relaxation aid in aromatherapy but is ill-suited to oral administration as it is rich in terpenes that give it poor sensory properties on the palate. Pharmako Biotechnologies, sister company of Gencor, overcame that limitation to oral use by developing a lavender oil in powder format that is compressible and suitable for use in tablets.

The unique delivery system developed by Pharmako, called CPO (Compressible Powdered Oils), was used to develop the powder lavender oil product. The powder has a high oil load of 50%. This enables delivery across multiple formats such as tablets, capsules, powders, sachets, RTD mixes etc. Products containing Lavender CPO are already on the US market and multiple projects are under development in other word markets. Lavender Oil also has EFSA pending claims in the EU for sleep.

Facilitating novel, effective products

The availability of three ingredients that act on different aspects of mood and sleep enables Gencor to support the development of unique dietary supplements in convenient formats. Customers can mix and match ingredients to create products tailored to the target market and population.

Whatever combination is used, companies can be confident that Gencor, with its background steeped in the pharmaceutical industry, has batch tested its materials and subjected them to the highest quality of validations and manufacturing control. Through those activities, Gencor is delivering clinically validated ingredients that aid mood, sleep and, by extension, immune health.

1​. Haspel, J. A. et al. Perfect timing: circadian rhythms, sleep, and immunity - an NIH workshop summary. JCI Insight 5, (2020).
2​. Rechtschaffen, A., Gilliland, M. A., Bergmann, B. M. & Winter, J. B. Physiological correlates of prolonged sleep deprivation in rats. Science 221, 182–184 (1983).
3​. Cappuccio, F. P., D’Elia, L., Strazzullo, P. & Miller, M. A. Sleep duration and all-cause mortality: a systematic review and meta-analysis of prospective studies. Sleep 33, 585–592 (2010).
4​. Prather, A. A., Janicki-Deverts, D., Hall, M. H. & Cohen, S. Behaviorally Assessed Sleep and Susceptibility to the Common Cold. Sleep 38, 1353–1359 (2015).
5​. Prather, A. A. et al. Sleep and antibody response to hepatitis B vaccination. Sleep 35, 1063–1069 (2012).
6​. Philips. Philips global sleep survey reveals an alarmingly sleep-deprived world. (2020).
7​. World Sleep Day 2021.
8​. Reimagining food retail in Asia after the COVID-19 pandemic.
9​. Huestis, M. A. et al. Cannabidiol Adverse Effects and Toxicity. Curr. Neuropharmacol. 17, 974–989 (2019).
10​. Montoya, Z., Conroy, M., Vanden Heuvel, B. D., Pauli, C. S. & Park, S.-H. Cannabis Contaminants Limit Pharmacological Use of Cannabidiol. Front. Pharmacol. 11, 571832 (2020).
11​. Griggs, J. L., Su, X. Q. & Mathai, M. L. Caralluma Fimbriata Supplementation Improves the Appetite Behavior of Children and Adolescents with Prader-Willi Syndrome. N. Am. J. Med. Sci. 7, 509–516 (2015).
12​. Kell, G., Rao, A. & Katsikitis, M. A randomised placebo controlled clinical trial on the efficacy of Caralluma fimbriata supplement for reducing anxiety and stress in healthy adults over eight weeks. J. Affect. Disord. 246, 619–626 (2019).

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