**These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Sleep & Stress ManagementTRANQUILITY™Life in the 21st century means constantly addressing situations that result in stress, anxiety, and a general feeling of being overwhelmed and unsettled. Disabling physical, emotional, and mental symptoms from stress and anxiety prevent people from leading a normal life. The yearly rate of prescriptions for anti-anxiety drugs has more than doubled in the last decade. Anti-anxiety medications, anti-depressants, and tranquilizers account for 25% of all prescriptions written in the U.S. each year. Our new Tranquility™ formula contains specific amino acids, vitamins, magnesium, and botanical medicines that restore and optimize neurotransmitter function. GABA (Gamma Aminobutyric Acid) is the primary inhibitory neurotransmitter that blocks impulses between nerve cells in the brain. Low levels of GABA can create anxiety, mood disorders, epilepsy, and even chronic pain. Taurine is another powerful inhibitory neurotransmitter. 5-HTP boosts serotonin, while L-Theanine reduces the levels of chemicals in the brain that are linked to stress and anxiety. Also, new to our formulation are three of the most effective and powerful botanical medicines for addressing stress and anxiety: Rhodiola, Magnolia, and ashwagandha. We also continue to include B6, B12, and folinic acid to supply essential nutrients that help improve and stabilize serotonin levels and neurotransmission.

8.9.19

TECHNICAL DATA SHEET

INGREDIENTS:

GABA (Gamma-Aminobutyric Acid)In the central nervous system, GABA is the primary inhibitory neurotransmitter. Neurotransmitters function as chemical messengers. GABA is considered an inhibitory neurotransmitter because it blocks, or inhibits, certain brain signals and decreases activity in the nervous system. GABA is used for relieving anxiety, stress, fear, elevating mood, and increasing feelings of well-being (1).

Ashwagandha Ashwagandha is an herb that has recently gained recognition as a treatment for anxiety and stress in the United States and is a revered herb of the Indian Ayurvedic system of medicine as a Rasayana (tonic). It is used for various kinds of disease processes and specifically as a nervine tonic. Many scientific studies have been carried out and its adaptogenic/anti-stress activities were studied in detail. Anxiety disorders are widespread and anxiety is often accompanied by stress, which is the body's physiologic response to mental or physical threats. Trial studies indicated Ashwagandha suppresses stress-induced increases of dopamine receptors in the corpus striatum of the brain (2).

5-HTP5-HTP is a chemical by-product of the protein building block L-tryptophan. It is also produced commercially from the seeds of an African plant known as Griffonia simplicifolia. 5-HTP is used to treat insomnia, depression, anxiety, migraine and tension-type headaches, attention deficit-hyperactivity disorder (ADHD), seizure disorder, and Parkinson’s disease. 5-HTP works in the brain and central nervous system by increasing the production of the chemical serotonin. Serotonin can affect sleep, appetite, temperature, sexual behavior, and pain sensation. Since 5-HTP can readily cross the blood-brain barrier, it increases central nervous system (CNS) synthesis of serotonin (3).Magnesium Magnesium status is highly associated with stress levels, with both stress and hypomagnesemia potentiating each other’s negative effects. Indeed, hypo-magnesemia has been associated with stressful conditions. Research shows that magnesium plays an important role in regulating neurotransmitters, which send messages throughout the brain and body (4). Magnesium increases GABA, which encourages relaxation and play a key role in regulating the body’s stress response system.

Amount per serving

Vitamin B6 (as Pyridoxine HCl)

Vitamin B6 (as Pyridoxal-5-Phosphate)

* Daily Value not established.

2

500

100

100

30

200

800

75

75

100

100

100

mg

mcg

mcg

mcg

mg

mg

mg

mg

mg

mg

mg

mg

%DV

100%

25%

25%

3846%

7%

*

*

*

*

*

*

*

5 *

Folinic Acid (as Calcium Folinate)

Vitamin B12 (Methylcobalamin)

Magnesium (as Citrate)

L-Taurine

GABA (gamma-aminobutyric acid)

5-HTP (5-Hydroxytryptophan)

L-Theanine

Rhodiola rosea (root) extract (3% rosavins)

Magnolia officinalis (bark) (90% honokiol)

Ashwagandha (root) (Withania somnifera)(4.5% withanolides)

Piperine mg

S u p p l e m e n t F a c t s Serving size: 2 capsule Servings per container: 45

mg *Taurine (free form)

New & Improved

211

Other Ingredients: vegetarian capsules (hypromellose, purified water)

Folinic Acid (as Calcium Folinate)Folinic acid is one active form in a group of vitamins known as folates. In the body, folinic acid may be converted into any of the other active forms of folate. Folinic acid raises the tetrahydrobiopterin (BH4) levels, which is a critical cofactor for the manufacture of all mood-regulating neuro-transmitters (10). Unlike regular folic acid supplements, up to 92% of folinic acid is absorbed from the gut following an oral dose. It remains in the body longer and the majority is converted to the active coenzyme. In this form, folinic acid can be taken up across the blood-brain barrier that ordinarily remains impermeable to dietary folates and which probably accounts for its efficacy in treating mental disorders (11).

L-TheanineL-Theanine is an amino acid, found traditionally in green tea , which relieves anxiety through its inhibitory neurotransmitting properties (6, 7, 15). L-theanine is an effective treatment of moderate and severe anxiety. The anti-anxiety effect of L-theanine is achieved through enhanced alpha brain wave activity and increased synthesis of GABA (8, 9). Increased GABA, in turn, increases brain levels of dopamine and serotonin, resulting in general feelings of calm and well-being. Changes in brain electrical activity measured by EEG are dose-dependent, and are similar to beneficial EEG changes observed in meditation, including increased alpha waves in the occipital and parietal regions. A calming effect is usually noted within 30 to 40 minutes after L-theanine is taken at a dose of 50 to 200mg, and typically lasts 8 to 10 hours.

Magnolia Honokiol and Magnolol are the major bioactive constituents of Magnolia bark. Honokiol is a polyphenolic compound that exerts neuroprotective properties through a variety of mechanisms. It has therapeutic potential in anxiety, pain, cerebrovascular injury, epilepsy, and cognitive disorders including Alzheimer’s disease. Honokiol is known for its anti-depressant qualities (16, 17). Honokiol results in neuronal protection through preservation of Na+/K+ ATPase, phosphorylation of pro-survival factors, preservation of mitochondria, and modulation of GABA. Honokiol further promotes neuronal health through prevention of glucose, ROS, and inflammatory mediated damage.

Patients: Consult with your healthcare professional for the proper dosage and use of this formula.

For more information about this and other Condition Specific Formulas® please visit our website at:

www.mountainpeaknutritionals.com

9953 SW Arctic Drive Beaverton, OR 97005

REFERENCES

8.12.19

Vitamin B6 (Pyridoxine/Pyridoxal 5 Phosphate)Pyridoxine is required for amino acid metabolism. In the body, pyridoxine is converted to coenzymes pyridoxal phosphate and pyridoxamine phosphate in a wide variety of metabolic reactions. These reactions include trans-amination of amino acids, conversion of tryptophan to niacin, synthesis of GABA in the central nervous system, metabolism of serotonin, nor-epinephrine and dopamine, metabolism of polyunsaturated fatty acids and phospholipids, and the synthesis of the heme group of hemoglobin (8). We use both forms of B6 to insure absorption is achieved as a number of people cannot convert pyridoxine into the biologically active form of pyridoxal-5-phosphate.

Vitamin B12 (Methylcobalamin)Methylcobalamin is the biologically active form of B12. Vitamin B12 is a naturally occurring B complex vitamin that is formed by microorganisms. Research indicates that low levels of B12 contribute to poor mood and feelings related to anxiety and depression. Levels of neurotransmitters in the brain of B12 deficient rats indicated norepinephrine levels were significantly decreased in the deficient animals compared to controls (9).

RhodiolaRhodiola is an herb that grows in the cold, mountainous regions of Europe and Asia. Its roots are considered adaptogens, meaning they help the body adapt to stress when consumed. Its root contains more than 140 active ingredients, the two most potent of which are rosavin and salidroside. People in Russia and Scandinavian countries have used Rhodiola to treat anxiety, fatigue, and depression for centuries. Consuming adaptogens during stressful times is thought to help one handle such situations better. Many of Rhodiola’s mood, stress, and cognition-enhancing results are credited to effects on monoamines in the CNS. Animal investigation and molecular studies suggest Rhodiola to increase 5-hydroxytryptamine and serotonin receptor expression and to act as µ-opioid receptor and κ-opiate receptor agonists, promoting the release of β-endorphin and exerting an anxiolytic, antiarrhythmic, and hypotensive action (5,12, 13, 14). Molecular studies demonstrate Rhodiola roots to have potent antidepressant activity by inhibiting monoamine oxidase (MAO).

L-TaurineTaurine is a conditionally essential amino sulfonic acid present in high amounts in meat and fish. During prolonged times of insufficient intake, such as parenteral nutrition, the body cannot maintain adequate levels of taurine and supplementation becomes necessary (6). Taurine is important in metabolism, especially in the brain. It is essential in newborns, as they cannot synthesize it. Adults can produce taurine from cysteine with the additional help of pyridoxine (B6). Taurine functions in electrically active tissues such as the brain and heart to stabilize cell membranes. Taurine is an inhibitory neurotransmitter, and its main use has been to help treat epilepsy and other excitable brain states (7). Neurotransmitter transport systems have a common structure of 12 presumed transmembrane helices and includes carriers for GABA, noradrenaline/adrenaline, dopamine, serotonin, proline, glycine, betaine, and taurine.

1. Principles of Med.Pharmacology.New York.NY:Oxford Univ Press 19982. Upton R, ed. Ashwagandha Root American Herbal Pharmscopoeia 2000:1-253. Cochrane Database Syst Rev 2002;(1):CD0031 4. Magnesium in the CNS, R Vink and M Nechifor ISBN-13 97809870730515. Phytomedicine. 2009;16(9):830–8. The effects of Rhodiola rosea extract on 5-HT level, cell proliferation and quantity of neurons at cerebral hippocampus of depressive rats. Chen QG, Zeng YS, Qu ZQ, Tang JY, Qin YJ, Chung P, Wong R, Hägg U.6. Ann Med 1999;31:318-27. Adv Pediatr 1985;32:1-428. McKevoy GK, ed AHFS Drug information Bethesda,MD:19989. Int J Vitam Nutr Res. 1977;47(2):119-210. Godfrey PS Toone BK, Carney NW et al. Lancet 1990;336:392-39511. Folates: Supplemental Forms and Therapeutic Applications by Gregory S. Kelly12. Zhongguo Zhong Yao Za Zhi. 2008;33(23):2842–6. Effects of Rhodiola rosea on level of 5-hydroxy-tryptamine, cell proliferation and differentiation, and number of neuron in cerebral hippo-campus of rats with depression induced by chronic mild stress. Qin YJ, Zeng YS, Zhou CC, Li Y, Zhong ZQ.

13. Eksp Klin Farmakol. 2000;63(4):29–31. Anti-arrhythmic effect of phytoadaptogens. Ma meskulova LA, Maslov LN.14. Phytother Res. 2015 Dec;29(12):1934-9. doi: 10.1002/ptr.5486. Epub 2015 Oct 27.15. Yoto A, Motoki M, Murao S, et al. Effects of L-theanine or caffeine intake on changes in blood pressure under physical and psychological stresses. J Physiol Anthropol. 2012;31:2816. Oiang LQ,Wang CP, Wang FM, PanY. Yi LT, Zhang X, et al. Combined administration of the mixture of honokiol and magnolol and ginger oil evokes antidepressant-like synergism in rats. Arch Pharm Res (2009) 32(9):1281–9210.1007/s12272-009-1914-6 [PubMed] [CrossRef] [Google Scholar]17. Xu Q Yi LT, Pan Y, Wang X, Li YC, Li JM, et al. Antidepressant-like effects of the mixture of honokiol and magnolol from the barksof Magnolia officinalis in stressed rodents. Prog Neuropsycho-pharmacol Biol Psychiatry (2008) 32(3):715–25 [PubMed] [Google Scholar]