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AND SLEEP:
Nutritional Support in
Mental Health and
the Role of PEA
Sponsored by
LEVAGEN®+ IS PALMITOYLETHANOLAMIDE (PEA)
A PROVEN SLEEP INGREDIENT
Foods and Beverages Stress and Sleep PEA for Sleep Support
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A Nation on Edge
The reawakening to wellness that consumers SPONSORED CONTENT
Julia Díaz, head of marketing, Pharmactive “It’s well known that tasty foods exert a
(Madrid), agrees. “The world is still awaiting full comforting effect and are widely adopted
recovery from this crisis,” she points out. “So coping mechanisms,” Díaz notes. And with
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some continuing pandemic restrictions
New Ingredient for Sleep: A Conversation with
Mariko Hill, Product Development Executive, Gencor extending consumers’ sense of cabin fever,
“the temptation to snack becomes even
What is PEA? greater,” she says.
PEA is a fatty acid amide that’s
produced in the body in response
to pain, inflammation, and Shafat notes that mood foods and drinks
stress. It was first identified as make the most sense when their constituent
a food component in the 1957,
originally derived from egg yolk. ingredients connote an association with calm
Throughout history, we started and relaxation. “In the case of stress, for
to see its anti-inflammatory and analgesic effects (i.e.,
pain relieving). As a result, Gencor started to study PEA example,” he says, “teas made with chamomile,
in the realm of joint health, sleep, and sports nutrition, lemon balm, cinnamon, rhodiola, and other
which is now distributed under our brand name
Levagen® and Levagen+®.
extracts with proven, or at least publicly
accepted, benefits can help to address it.”
Can you talk about the science and the research
behind Levagen+, specifically for sleep health?
Gencor has conducted many human clinical trials on Díaz detects an echo between consumers’
Levagen and Levagen+. To date, we have completed adoption of mood foods and “the growing
six studies. All are either published or have been
submitted for publication. Our latest one is on sleep awareness of self-care and healthy habits,”
health. We tested 125 healthy adults in a double-blind, which she says can include everything from
randomized, placebo-controlled trial. Compared to
placebo, individuals fell asleep 3x faster (measured choosing organic produce to reducing
using sleep latency), feel more awake the next day, had sugar consumption.
improved cognition upon awakening, and didn’t feel
drowsy. If you look at the sleep health category as a
whole, it has been a sea of sameness. With Levagen+, And Shafat cites a very practical reason for
we are taking a more holistic approach to sleep health
than many of the sleep health ingredients on the
using food to improve mood: “Many active
market. And we have the science to back up our claims. ingredients are better absorbed when taken
with food,” he says. “And liquid formats like
We heard you’re working with a few elite sports teams
with Levagen+. Can you elaborate on what you have beverages move more quickly through the
found? GI tract.” By contrast, supplement capsules
We wanted to gain practical insights into how PEA is
used in an elite sports setting. One of our good friends, and tablets must disintegrate first before
James Hudson, is the nutritionist of Gloucester Rugby, allowing their actives to dissolve and the
and he was keen on using PEA as a CBD and even an
NSAID alternative. He was interested in using Levagen+ body to absorb them, he says.
to reduce tendinopathy pain and possibly influencing
sleep. Not only did he see a decrease in tendinopathy,
but he also saw a reduction in time to sleep per the Relaxing Actives
gold standard—the Pittsburgh Quality Questionnaire for As for which mood-improving ingredients
Sleep. This is really interesting because this effect was
not only seen in the clinical setting, but in the applied
are getting play in food and beverage
setting, too. formulations, both Díaz and Shafat shine a
spotlight on botanicals. Díaz sees the plant-
Interested in hearing more? LISTEN TO OUR PODCAST
based ingredients as capitalizing on their
“long history of traditional use to aid sleep
and induce calm.” That history not only Probiotics are already building a track record
strikes consumers as “natural” and evokes in this arena. A randomized, double-blind,
their trust; on the manufacturing side, it placebo-controlled study involving 120
can also relieve brands of the regulatory healthy subjects aged 18 to 45 found that
concerns surrounding ingredients like CBD. IFF’s Howaru Calm probiotic (Lactobacillus
paracasei Lpc-37) improved psychological and
Díaz notes that sales of Affron, Pharmactive’s physiological markers of stress and anxiety in
natural saffron (Crocus sativus L.) extract, subjects who took the ingredient.4
have been rising in concert with demand for
calming formulations. “That’s a big development,” Shafat says. “It
gives consumers a scientifically proven way
Previous clinical studies have established to manage daily stress by taking a probiotic
its capacity to support mood and relaxation, they can buy online or in a store.”
relieve stress and improve sleep, she notes,
while adding that a recent clinical study of Working Out the Kinks
12- to 16-year-olds with mild to moderate Formulators will have to approach the task
anxiety and depression showed that of developing mood foods and beverages
subjects who took the extract over an differently from how they’d build a
eight-week period experienced traditional supplement. As Shafat cautions,
improvements in symptoms.3 “Adding any functional ingredient to a food
or beverage poses challenges to processing,
The extract’s proposed mechanism of shelf stability, solubility, taste, and more.”
action rests on its antioxidant and anti-
inflammatory properties, which may help And as any food or beverage developer
balance levels of key neurotransmitters like knows, “Consumers drink and eat what’s
serotonin and dopamine while also fighting tasty,” Shafat says. “That’s driving the
the oxidative stress that anxiety and stress industry’s focus toward adapting these
can trigger in the brain. ingredients—many of which are bitter—to
foods and beverages using ingredients like
Meanwhile, Shafat looks to the gut-brain axis flavor maskers.”
for further hints as to where mood food may
be headed. It’s not just product appeal that hangs in the
balance, either; it’s consumer compliance.
“As consumers begin to understand the After all, a mood-enhancing food or drink
connection between our brains and our will only work if consumers feel compelled to
microbiome more widely,” he says, “the consume it on the regular. “These products
category of probiotic-fortified foods and have to be linked to daily, rather than
beverages for stress and mood should grow.” occasional, consumption,” Díaz says. “Natural
solutions usually work better this way.” of youth anxiety and depressive symptoms: a
randomized, double-blind, placebo-controlled
Brands also must remain measured in making study,” Journal of Affective Disorders. Published
promises for their products. Díaz reiterates online February 26, 2018.
the importance of drawing hard lines at 4. Patterson E et al. “Lacticaseibacillus paracasei
claiming to diagnose, cure, mitigate, treat, or Lpc-37® improves psychological and
prevent disease. And she encourages brands physiological markers of stress and anxiety in
to support any claims they do make with healthy adults: a randomized, double-blind,
rigorous scientific evidence. placebo-controlled and parallel clinical trial (the
Sisu study).” Neurobiology of Stress. Published
As research into mood-enhancing actives online November 24, 2020.
proceeds, that evidence will only mount.
Says Shafat, “New research on mood and
relaxation is taking place to offer more Kimberly J. Decker
substantiation for active ingredients. This will Freelancer Writer
result in more acceptable mood-food and
The article was first published by Nutritional
-beverage formulations for both the industry Outlook, July 26, 2021.
and consumers.”
References
1. Panchal N et al. “The Implications of COVID-19
for Mental Health and Substance Use.” Kaiser
Family Foundation website. Published February
10, 2021. Accessed here. https://www.kff.
org/coronavirus-covid-19/issue-brief/the-
implications-of-covid-19-for-mental-health-and-
substance-use/
2. Daniells S. “Stress Management Supplements
Sales Surge with Sleep and Adaptogen Lines
Leading the Way.” Nutraingredients-USA.
com. Updated August 18, 2020. Accessed
here. https://www.nutraingredients-usa.com/
Article/2020/08/18/Stress-management-
supplements-sales-surge-with-sleep-and-
adaptogen-lines-leading-the-way#
3. Lopresti AL et al. “Affron, a standardized extract
from saffron (Crocus sativus L.) for treatment
amenic181/stock.adobe.com
T
Why stress and he pandemic permanently disrupted the lives of people all
over the world, and it very well may continue to do so as we
sleep support is approach the post-pandemic phase. Many “normalcies” of
so important in life have been drastically altered over the past year, work,
2021. education, sports, health care, politics, and relationships, to name a few.
Suffering in Silence
Over the past year, the number of people looking for help in
addressing their anxiety has skyrocketed. The 2021 State of Mental
Health in America report showed that from January to September
2020, 315,000+ people took the anxiety MHA (Mental Health
America) screen test, a 93% increase over the 2019 total number of
anxiety screens.1
As society attempts to get back to “normal,” While getting adequate sleep, managing
many are carrying with them some baggage stress are effective ways to help maintain
that psychiatrists are calling Post-Covid a healthy immune system, science has
Stress Disorder (PCSD), which may lead to shown that nutrients gained through a
diverse mental health problems, including healthy diet or supplementation are critical
anxiety, depression, post-traumatic stress in maintaining balance.
disorder, and other trauma- and stress-
related disorders.12 According to the FMCG Gurus’ survey
series 2020, 18% of consumers have
Medical practitioners have seen increased become more conscious about their sleep
stress, burnout, sleep disturbance, anxiety, health and 40% said this about their overall
depression, trauma-related disorders, and a mental well-being15 and it didn’t take long
general sense of grief of the life we knew. for companies to take notice. New brands,
There will likely be a broad spectrum of products, and even mobile apps continue to
pop up, looking to capitalize on this demand antioxidant18 with benefits for immune
as the global sleep economy is big business. health and sleep health.
According to Statistica, it was valued at
$432 billion in 2019 and is set to reach $488 Saffron is another multi-beneficial ingredient
billion in 2021 and $585 billion by 2024.16 that has been extensively researched with
new evidence suggesting it may be an
Don’t Snooze on These effective natural sleep aid. In a small pilot
Natural Ingredients study, the four-week administration of a
Addressing the concerns associated with saffron extract (affron) resulted in greater
sleep starts with consumers looking at their improvements in sleep quality, sleep latency,
health as an interconnected system versus and daytime dysfunction in a subset of
a one-system approach. According to a new poor sleepers compared with placebo with
Innova Market Insights survey, the research no significant adverse events reported.19 A
revealed that seven out of ten consumers 2018 randomized, double-blind, placebo-
made changes over the past year to improve controlled study also showed that 28 mg/
their overall health. Interestingly, the day of saffron (affron) had a positive effect
changes were not just for physical health, on anxiety and depressive symptoms in
but were also focused on balancing physical, adolescents (12-16 years) with mild-to-
mental, and emotional aspects.17 moderate symptoms over 8 weeks20, so
beneficial in improving mood health as an
It should come as no surprise that some of added bonus.
the most recent trending ingredients include
not only benefits for immune function but When a new virus appears, a renewed focus
cognitive health, heart health, sleep, and on immunity health is seen. In the absence of
overall vitality. One of these ingredients vaccines, the body’s innate immune system is
that offers multiple benefits is curcumin. In the primary defense against pathogens, and
a 2020 clinical study, curcumin (Hydrocurc) all too often, consumers fall back on synthetic
was combined with iron, and results showed anti-inflammatory drugs that have applications
benefit in significantly increasing serum in the short-term but are too toxic for long-term
BDNF and ferritin levels, which may suggest and/or preventive use at the public health level.
the ability to enhance cognitive function Endogenous and/or food-derived supplements
(memory & learning) and increase the growth have shown to be safer alternatives.21
of new neurons and may help fight various
degenerative processes in your brain. Palmitoylethanolamide (PEA) is an
endocannabinoid-like lipid mediator with
Curcumin has beneficial effects on several extensively documented anti-inflammatory,
factors known to play a role in CVD. analgesic, antimicrobial, immunomodulatory
Plus, it is an anti-inflammatory agent and and neuroprotective effects. It is well
tolerated and devoid of side effects in benefit of mood health, brain health and
animals and humans. PEA’s actions on immunity health is a win-win. Sleep well.
multiple molecular targets while modulating
multiple inflammatory mediators provide References
therapeutic benefits in many applications, 1. Mental Health America. The 2021 State Of Mental
including immunity, brain health, allergy, pain Health In America. https://www.mhanational.org/
modulation, joint health, sleep, and recovery.21 issues/state-mental-health-america
2. KFF. Adults Reporting Symptoms of Anxiety or
In a 2020 study, players from the Gloucester Depressive Disorder During COVID-19 Pandemic,
English Rugby Union team took a PEA 4/28/2021-5/10/2021. https://www.kff.org/
product, Levagen+, to aid with recovery from other/state-indicator/adults-reporting-symptoms-
the demands of their sport, but what they of-anxiety-or-depressive-disorder-during-
didn’t know was the applications of PEA covid-19-pandemic/?currentTimeframe=0&so
in sleep. rtModel=%7B%22colId%22:%22Location%22,-
%22sort%22:%22asc%22%7D
The club was already tracking sleep, and they 3. National Center for Health Statistics. Early
saw a shift after players began taking the Release of Selected Mental Health Estimates
PEA product. Based on Data from the January–June 2019
4. National Health Interview Survey. https://
Over the first 12 weeks of PEA (Levagen+) www.cdc.gov/nchs/data/nhis/earlyrelease/
use, the club saw a significant improvement ERmentalhealth-508.pdf
in sleep quality as measured by the 5. KFF. The Implications of COVID-19 for Mental
Pittsburgh Sleep Quality Index with players Health and Substance Use. Feb. 10. 2021. https://
reporting improvements in the quality of www.kff.org/coronavirus-covid-19/issue-brief/
their sleep. Some players even reported the-implications-of-covid-19-for-mental-health-
near reversals of insomnia symptoms. and-substance-use/
These findings are in line with broader 6. KFF. KFF Health Tracking Poll - July 202. July 27,
understanding of the prominent role 2020. https://www.kff.org/coronavirus-covid-19/
endocannabinoids may play in sleep.22 report/kff-health-tracking-poll-july-2020/
7. M. Gavidia. How Has COVID-19 Affected Mental
The importance of sleep has long been Health, Severity of Stress Among Employees?
understood, and English dramatist and April 20, 2020, https://www.ajmc.com/view/how-
pamphleteer Thomas Dekker once said, has-covid19-affected-mental-health-severity-of-
“Sleep is the golden chain that ties health stress-among-employees
and our bodies together,” and through 8. American Psychological Association. Stress in
scientific research, we are seeing a renewed America™ 2020. https://www.apa.org/news/
focus being placed on it. Finding novel press/releases/stress/2020/report-october
solutions to sleeping well with the added 9. American Psychological Association. Infographic.
Asier/stock.adobe.com
Why is PEA As strange as it sounds, humans spend about one-third of their life
either sleeping or trying to fall asleep.1
and how does it
support sleep? Sleep is an essential function1 that allows both body and mind some
time recharge. Healthy sleep also helps the body remain strong
and stave off chronic health conditions. Without enough sleep, the
brain cannot function properly, which can impair your ability2 to
concentrate, think clearly, and process memories.
RECOMMENDED AMOUNT
AGE GROUP AGE RANGE
OF SLEEP PER DAY
The right amount of sleep largely depends to cause sleep deprivation in animal models
on your age. The National Sleep Foundation and in humans.9 More and more, people
recommends the following daily sleep are looking for other natural solutions that
allotment for different age groups.5 improve sleep quality without any of these
adverse effects.
Easier Said Than Done
Falling asleep is a simple concept, and should In Search of a Safe Sleep
be easy to do, however multiple factors such Benefits of an effective sleep aid to look for:
as environmental and psychosocial stressors
as well as certain medical conditions can give • Shortens the amount of time people
rise to a range of sleep disorders.6,7 Another spend lying awake tossing and turning
factor that poses challenges with sleep is • Provides a good night’s sleep—the
chronic pain. In fact, joint pain’s effect on quality of sleep is important as any
sleep has been studied extensively and has product that puts someone to sleep
been associated with poor sleep quality.6 Far quickly but leaves them feeling groggy
too often, the answer seen to address these in the morning only addresses part of
challenges with a variety of “sleep aids” like the problem
prescription sedatives and tranquilizers that • Is safe and dependable—decreased chance
are widely used for treating sleep disorders,8 of addiction or other adverse effects
but these carry the risk of addiction and other
adverse effects. While they might prove to be While there are some popular sleep aids on
beneficial in the short term, withdrawal after the market right now, most notably valerian
chronic cannabinoid use has been shown and melatonin, they aren’t without their
making it extremely effective and fast acting. a cross-sectional analysis of the Nagahama
study. PLoS One. vol. 10, issue 10, (October
Sleep Safely 2015): e0140058. https://pubmed.ncbi.nlm.nih.
As a self-affirmed GRAS ingredient, Levagen+ gov/26444713/
PEA also received the Informed Ingredient 7. Kalmbach DA, Anderson, JR, and Drake CL,
Certification for absence of WADA-prohibited The impact of stress on sleep: Pathogenic sleep
substances from LGC, the United Kingdom’s reactivity as a vulnerability to insomnia and
designated National Measurement Institute circadian disorders. Journal of Sleep Research. vol.
for chemical and biomeasurement. 27, issue 6 (Dec. 2018), e12710. doi: 10.1111/
jsr.12710. Epub 2018 May 24.
PEA is applicable to consumers across their 8. Cappuccio FP, D’Elia L, Strazzullo P, Miller
lifespan. There are limited sleep health MA. Sleep duration and all-cause mortality:
supplements that are safe, clinically studied, a systematic review and meta-analysis of
and able to avoid the groggy hangover effects. prospective studies. Sleep. 2010 May;33(5):585-
Fortunately, (Levagen+) PEA is able to check 92. doi: 10.1093/sleep/33.5.585
off all those boxes, and knowing this, sleep 9. Kesner AJ and Lovinger DM. Cannabinoids,
can come easier in the safest possible way. endocannabinoids and sleep. Frontiers in Molecular
Neuroscience. vol. 13 (July 2020), 125.
References 10. Spritzler F. How valerian root helps you relax
1. Aminoff MJ, Boller F, Swaab DF. We spend about and sleep better. April 16, 2017, https://www.
one-third of our life either sleeping or attempting healthline.com/nutrition/valerian-root#TOC_
to do so. Handbook of Clinical Neurology. vol. TITLE_HDR_9
98, issue vii (2011). doi: 10.1016/B978-0-444- 11. “Is melatonin a helpful sleep aid — and what
52006-7.00047-2. PMID: 21056174. should I know about melatonin side effects?”
2. NIH, Brain Basics: Understanding Sleep. https:// https://www.mayoclinic.org/healthy-lifestyle/
www.ninds.nih.gov/Disorders/Patient-Caregiver- adult-health/expert-answers/melatonin-side-
Education/understanding-Sleep effects/faq-20057874
3. CDC. https://www.cdc.gov/sleep/features/ 12. Huestis, M. A. et al. Cannabidiol adverse effects
getting-enough-sleep.html and toxicity. Current Neuropharmacology. vol. 17,
4. Suni E. How much sleep do we really need? issue 10, 974–989 (2019).
March 10, 2021. https://www.sleepfoundation. 13. Montoya, Z., Conroy, M., Vanden Heuvel, B. D.,
org/how-sleep-works/how-much-sleep-do-we- Pauli, C. S. & Park, S.-H. Cannabis Contaminants
really-need Limit Pharmacological Use of Cannabidiol.
5. Foley L. Why do we need sleep? September 11, Frontiers in Pharmacology. 11, 571832 (2020).
2020. https://www.sleepfoundation.org/how- 14. Murillo-Rodriguez E. The role of the CB1 receptor
sleep-works/why-do-we-need-sleep in the regulation of sleep. Progress in Neuro-
6. Murase K et al. Knee pain and low back pain Psychopharmacology and Biological Psychiatry.
additively disturb sleep in the general population: volume 32, issue 6, (August 2008), 1420-1427.