Clarify 4.0 Formula Monograph

Clarify 4.0 is a comprehensive dietary supplement formulation targeted to support the production of dopamine which is involved in reward deficiency, and focus, Clarify 4.0 is for TRIAD 2 reward issues including eating past full, addictions and other reward-based behavioral deficits as well as improvement in focus and mental clarity.

Supplement Facts Serving Size: 3 capsules Servings Per Container: 30

Nutrient Amount Per % Daily Formula Use(s) Serving Value Riboflavin (Vitamin B2) 25 mg 1923% • Mitochondrial energy production • Growth, and development • Metabolism of fats, drugs, and steroids • Helps improve methylation and decrease inflammation • B vitamins help decrease adrenal stress issues Pyridoxine HCL, Pyridoxal-5-phosphate + 30 mg 1765 % • Important in energy production and Pyridoxine phosphate neurotransmitter synthesis (Vitamin B6) • Supports methylation and decrease inflammation • Pyridoxal-5-phosphate is highly absorbable and improved clinical utility • B vitamins support adrenal function

Quatrefolate 1 mg 250 % • 5-methyltetrahydrofolate – the active 5-methyltetrahydrofolate form of folic acid, complexed with (Vitamin B9) glucosamine for improved absorption and bioavailability • Supports methylation and decreases homocysteine formation • Reported to help improve neurochemical balance Vitamin B12 (50% metylcobalamin, 50% 1 mg 41667% • Essential B vitamin adenosylcobalamin) • Important in nerve development and protection • Stress reported to deplete reserves of B12 • Supports methylation and decreases inflammation Mucuna (Mucuna pruriens) seed 300 mg * • Supports dopamine pools Standardized to 40% L-DOPA • Helps balance reward cascade system • Supports improved clarity Theobromine 98% 300 mg • Improves mood • Improves cognition • Improves energy level Trimethylglycine (betaine) 300 mg • Component of beet root • Active metabolite of choline • Important osmolyte in kidney medulla • Increases endogenous SAMe (s- adenosyl methionine) • Nourishes nerve cells • Important in methylation – reduces Homocysteine • Cardioprotective • Ergogenic • Promotes cellular hydration Theacrine 300 mg * • Provides mild stimulation without Isolated from Camellia assamica var. Kucha “jitters” • May improve cognition and focus • Also helps with calming • Improves dopamine signaling • Sedative / hypnotic properties • Improves reaction time

* Daily value not established.

Recommended Uses: Helps support the production of neurochemicals involved in satiety and reward, and to help improve focus and clarity by supporting dopamine production in the brain.

Recommended Dosages: 2 capsules in the morning and 1 capsule in mid-afternoon daily.

Product Overview: Clarify 4.0 contains dietary supplements that help with neurochemical balance, and is formulated to help support dopamine pools in order to balance the reward cascade system, which decreases cravings.

Supporting Research: Mucuna (Mucuna pruriens) seed Mucuna, or Velvet Bean, helps support healthy dopamine levels, important in managing the reward cascade and decreasing craving symptoms.1 Mucuna contains L-Dopa, and L-dopa is used to make dopamine, the neurochemical involved in behavior and cognition, voluntary movement, motivation and reward, inhibition of prolactin, sleep, mood, attention and learning. In laboratory animal studies and in human trials, mucuna has been reported to possess anti- parkinsonian and neuroprotective effects.2,3 Mucuna also has antioxidant properties, which can lead to further neuro-protection.

One of the traditional uses of mucuna is in the area of blood sugar imbalance. Laboratory animal studies support the use in blood sugar regulation through improving plasma glucose levels, helping prevent polyuria and helping to decrease urinary albumin levels.4 High levels of trace elements like manganese and zinc along with lecithin are found in the seeds and may be a possible link to the ability of mucuna to regulate blood sugar and promote weight loss.

Pyridoxal-5’-Phosphate (P-5-P) + Pyridoxine HCl (Vitamin B6) B6 is an essential co-factor for glycogen phosphorylase and certain enzymes in the alanine- glucose cycle that help produce energy.5 Clinical studies have report improved fuel reserves during exercise when using B6 supplements.6 Pyridoxal 5'-phosphate is a form of vitamin B6 that has improved bioavailability and clinical utility.

Riboflavin-5-Phosphate (Vitamin B2) Riboflavin is essential for mitochondrial energy production, normal growth and development, reproduction, lactation, neurosupport, physical performance, and general well-being. It participates in essential biochemical reactions, especially those that yield energy.7 Vitamin B2 is water-soluble and, like other B vitamins, it is not appreciably stored and must be supplied daily. Riboflavin-5-phosphate is a superior bioavailable form of riboflavin.

Methylcobalamin + Adenosylcobalamin (Vitamin B12) Methylcobalamin and adenosylcobalamin as B12 (active forms of vitamin B12) are essential for recycling homocysteine and the formation of methyl donors involved in cardiovascular function, sleep, blood cell formation, and neurological function.8 B12 is important in energy production and metabolism. B12 is an important antioxidant supplement also.

Quatrefolate (Folic acid/Vitamin B9) Quatrefolate is (6S)-5-methyltetrahydrofolate glucosamine salt, patented, a highly bioavailable and stable form of folic acid. The mechanism of action of Quatrefolate is related to the action of 5-methyltetrahydrofolate the active part of the proprietary ingredient. 5- methyltetrahydrofolate derives from tetrahydrofolic acid, through a series of metabolic reactions. Tetrahydrofolate acid acts as a coenzyme in several vital metabolic reactions

© Copyright 2020, Metabolic Code Enterprises, LLC and Jim LaValle, v1.0 participating in the transfer as acceptors and donors of various one-carbon fragments, involved in the biosynthesis of nucleotides purines and pyrimidine’s and in the metabolism of several important amino acids.

In concert with vitamin B12, folate coenzymes allow the conversion of the amino acid homocysteine to methionine; the lack of this conversion has been associated with various pathologies and diseases. Conversion of tetrahydrofolic acid to 5-methyltetrahydrofolate is mediated by the action of the enzyme methylentetrahydrofolate reductase. In individuals with a genetic defect of methylentetrahydrofolate reductase, enzyme conversion is limited, predisposing these individuals for an increased risk for certain disease conditions.

Supplementation with 5-methyltetrahydrofolate might be preferable to folic acid, being it is immediately available to react with homocysteine to avoid the possibility of hyperhomocysteinemia.

Trimethylglycine (TMG, Betaine) Betaine (trimethylglycine), formed from choline, is the trimethylated compound of the amino acid glycine, is an essential biochemical component of the methionine/homocysteine cycle. Betaine is commonly used as a methyl (CH3) donor to lower plasma homocysteine levels. Betaine is also lipotropic (improves liver function). Betaine also helps maintain intercellular osmolarity and protects proteins from becoming denatured. Food sources of betaine include beets, liver, eggs, fish, legumes, and whole grains. Betaine was first discovered in the juice of sugar beets (Beta vulgaris) in the 19th century and was subsequently found in several other organisms.

Supplemental TMG is rapidly absorbed and distributed throughout the body, with peak concentrations being reached in less than one hour. TMG is used for:9 • Osmolyte - Promotes cellular hydration • Hyperhomocysteinemia • Liver health (NAFLD) • Cardiovascular health • Kidney health • Neuroprotective • Performance improvement

Theacrine Theacrine (1,3,7,9etramethyluric acid) is a purine alkaloid found in certain coffee (Coffea) species, fruits (Cupuacu [Theobroma grandiflorum]), and tea (Camellia

© Copyright 2020, Metabolic Code Enterprises, LLC and Jim LaValle, v1.0 assamica, var. kucha) that has antiinflammatory, analgesic, and neurolocomotor properties. P reliminary research has also reported increased feelings of energy, reduced fatigue, and s trong effects on improving focus, concentration, and motivation to exercise. A clinical study using 60 adult males and females took 300mg Teacrine or placebo once daily for 8 weeks. Their findings support the clinical safety and non-habituating neuro-energetic effects of Theacrine.10

Theobromine Theobromine is alkaloid prepared from the dried ripe seed of Theobroma cacao or made synthetically from xanthine11. Theobromine is a catabolic product of caffeine and thus has physiological properties similar to those of caffeine, including mental alertness and slight stimulation. Caffeine, theobromine and xanthine have a quenching effect on the production of hydroxyl radicals, as well as on oxidative DNA breakage by hydroxyl radicals. However, consistent with previous observations that many known antioxidants of plant origin are also capable of prooxidant action, the purine alkaloids also show oxidative DNA breakage in the presence of transition metal ions.12

Methylxanthines also have an anti-inflammatory effect, reportedly by inhibiting primary amine oxidase and monoamine oxidase activity in humans.13 Theobromine is also a diuretic, acting by inhibiting reabsorption of sodium and chloride in the renal tubules. Theobromine may increase heart rate, so use with caution in those with cardiovascular issues.

Toxicity, Contraindications, or Side Effects: • There are no known toxicities or side effects from taking ingredients in Clarify 4.0 in recommended dosages. • Use with caution If taking L-DOPA or Sinemet (carbidopa-levodopa). The Mucuna in Clarify 4.0 is standardized to 40% L-DOPA. • Theobromine may increase diuresis. Use with caution in those with cardiovascular conditions and/or on diuretic and cardiovascular medications. • Theobromine may increase heart rate, so use with caution in those with cardiovascular issues.

† DISCLAIMER: This material is provided for educational and informational purposes only. This information is obtained from sources believed to be reliable, but its accuracy cannot be guaranteed. Herbs and other natural substances are powerful and can occasionally cause allergic reactions in a small percentage of the population. Licensed health care professionals should rely on sound professional judgment when recommending herbs and natural medicines to specific individuals. Individual use of herbs and natural medicines should be supervised by an appropriate health care professional. The use of any specific product should always be in accordance with the manufacturer's directions.

1 Shukla KK, Mahdi AA, Ahmad MK, et al. Mucuna pruriens improves male fertility by its action on the hypothalamus-pituitary-gonadal axis. Fertil Steril. 2009;92(6):1934-40. 2 Katzenschlager R, Evans A, Manson A, et al. Mucuna pruriens in parkinson’s disease: a double-blind clinical and pharmacological study. J Neurol Neurosurg Psychiatry. 2004;75(12):1672-7. 3 Manyam BV, Dhanasekaran M, Hare TA. Effect of antiparkinson drug HP-200 (Mucuna pruriens) on the central monoaminergic neurotransmitters. Phytother Res. 2004;18(2):97-101. 4 Rathi SS, Grover JK, Vats V. The effect of Momordica charantia and Mucuna pruriens in experimental diabetes and their effect on key metabolic enzymes involved in carbohydrate metabolism. Phytother Res. 2002 May;16(3):236-43. 5 Manore MM, Leklem JE. Effect of carbohydrate and vitamin B6 on fuel substrates during exercise in women. Med Sci Sports Exerc. 1988;20(3):233-41. 6 Manore MM, Leklem JE. Effect of carbohydrate and vitamin B6 on fuel substrates during exercise in women. Med Sci Sports Exerc. 1988;20(3):233-41. 7 Hakur K, et al. Riboflavin and health: a review of recent human research. Crit Rev Food Sci Nutr. 2017;p57(17):3650-3660. 8 Spence. B vitamin therapy for homocysteine renal function and vitamin B12 determine cardiovascular outcomes. Clin Chem Lab Med. 2013;51(3):633-7. 9 Craig S. Betaine in human nutrition. A J Clin Nutr. 2004;80(3):539-49. 10 Taylor L, et al. Safety of Teacrine a non-habituating naturally occurring purine alkaloid over eight weeks of continuous use. J Int Soc Sports Nutr. 2016;13(1):2. 11 Azam S, et al. Antioxidant and prooxidant properties of caffeine, theobromine and xanthine. Med Sci Monit. 2003;9(9):BR325-330. 12 Azam S, et al. Antioxidant and prooxidant properties of caffeine, theobromine and xanthine. Med Sci Monit. 2003;9(9):BR325-330. 13 Ahmed H, Methylxanthines inhibit primary amine oxidase and monoamine oxidase activities of human adipose tissue. Medicines (Basel). 2020;7(4):E18.