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3.1 Clinical trials
A 2011 article in BMC Psychiatry concluded that the predecessor formulations of Hardy Nutritionals® Daily Essential Nutrients (DEN) were the only complex micronutrient formulas which had been studied extensively for mental health treatment.16 More recently, DEN significantly improved attention, mood dysregulation, and global functioning in “the first fully-blinded, randomized, controlled trial of medication-free children with ADHD”.17 More than 30 medical journal articles have been published on these formulations, all but two of which are peer-reviewed. The study designs employed in the published articles include controlled trials, case reports, case studies with years of historical information, database analyses, randomized controlled trials, and double-blind randomized controlled trials (see Appendix A).
Consistent research results have been found independently by scientists at more than a dozen institutions in several countries. None of the researchers have had financial ties to these formulations or to Hardy Nutritionals®.
Important research using DEN is ongoing.
3.2 Mechanism of action
The exact mechanism by which DEN exerts its therapeutic effect is not entirely understood. It is presumed to be linked to the various roles of vitamins and minerals in the synthesis,18-24 neurotrophicity, and regulation 25-32 of neurotransmitters in the brain (see Appendix G). Clinical observations of “pervasive upregulation of CNS functions” and “[potentiation of] virtually all CNS-active drugs”1 suggest wide-ranging holistic effects.
Genetic polymorphisms (variations) can often result in increased requirements for nutrient cofactors in enzyme pathways, and higher nutrient intakes have been shown to ameliorate the effects of many of these genetic conditions.33-35
In animal studies, accelerated structural and functional recovery of neurons was observed following experimentally-induced brain lesions when animals were supplemented with a predecessor formula of DEN.36 Similar structural, chemical, and functional neuronal deficits exist in mood and cognitive dysregulation in humans37-39 which would presumably respond in a similar way to DEN therapy.
Strong evidence exists that the nutrient density of foods for human consumption has declined over the last century, and the percentage of people who ingest the recommended intake of many of the essential nutrients is dismally low in populations consuming a “western” diet. Well-documented correlations are also emerging between human disease and the use of nutrition-compromising practices in modern agriculture.
While causation may be difficult to prove for a mechanism that spans the entire food chain, the documented clinical efficacy of essential nutrient repletion is suggestive of pervasive and insidious micronutrient insufficiency in a variety of illnesses – probably biomagnified from the soil, to microbiota, to plants, to animals, and finally to humans. Considering that a nutritionally-compromised food supply is presented to the modern human through the potential additional filter of food processing, and considering the prevalence of poor diet and lifestyle choices, environmental exposure to harmful chemicals, and even certain medical practices that may compromise nutrient absorption and utilization (such as overuse of oral antibiotics in early childhood), the theoretical basis for supplementation of essential nutrients becomes compelling.
In humans, DEN pharmacodynamics are presumed to be a complex interaction of individual nutrient pharmacodynamics, many of which have been studied extensively.40-45
3.4 Absorption and metabolism
3.4.1 Systemic bioavailability
As yet, there are no publications regarding nutrient bioavailability of DEN after a single oral dose. As per manufacturer specifications, complete dissolution occurs in less than 8 minutes after a DEN capsule is fully hydrated.
It is not known to what degree food affects the systemic bioavailability of DEN. Although food may decrease the rate of absorption, this effect does not appear to be clinically significant. Administering DEN with food is recommended.
The vitamins and minerals in DEN are presumed to be metabolized in the same way as those in foods and similar supplements.40-45 The complexity of DEN metabolism may affect medication pharmacokinetics (see 5.2 Drug interactions and Appendix G).
The effect of age upon the metabolism of DEN has not been systematically investigated. No unusual age-associated pattern of adverse events has been observed in children, adolescents, or the elderly.16
It is not known how renal or liver impairment can affect the metabolism of DEN.