Clinical Pharmacology

2.1 Clinical Trials
According to a recent article in A. Daily Essential Nutrients (DEN) and similar broad-spectrum micronutrient formulations have been extensively researched as interventions for mental health symptoms. The study designs employed in the published articles range from double-blind research to case studies with years of historical information and two database analyses (see Appendix A).

Consistent research results have been found across scientists at more than a dozen independent institutions in several countries. None of the researchers have had financial ties to these formulations.

Significant research is continuing with the Daily Essential Nutrients formulation.

2.2 Mechanism of Action
The exact mechanism by which Daily Essential Nutrients 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(2-8)  and regulation(9-16)  of neurotransmitters in the brain.

In addition, genetic polymorphisms (variations) can often result in increased requirements for nutrients in enzyme pathways, and higher nutrient intakes have been shown to ameliorate the effects of many of these genetic conditions.(17-19)

2.3 Pharmacodynamics
In humans, Daily Essential Nutrients pharmacodynamics are presumed to be a complex interaction of individual nutrient pharmacodynamics, many of which have been studied extensively.(20-25)

In animal studies, accelerated structural and functional recovery of neurons were observed following experimentally-induced brain lesions when animals were supplemented with a micronutrient formula substantially similar to DEN Daily Essential Nutrients.(26)  Similar structural, chemical, and functional neuronal deficits exist in mood and cognitive regulation in humans(27-29)  which would presumably respond in a similar way to Daily Essential Nutrients therapy.

2.4 Absorption and metabolism


2.4.1 Systemic bioavailability
As yet, there are no publications regarding nutrient bioavailability of Daily Essential Nutrients after a single oral dose.

2.4.2 Metabolism
The vitamins and minerals in Daily Essential Nutrients are presumed to be metabolized in the same fashion as those in foods and similar supplements.(20–24) The complexity of Daily Essential Nutrients metabolism may affect medication use (see 4.2 Drug interactions).

The effects of age upon the metabolism of Daily Essential Nutrients has not been systematically investigated. No unusual age-associated pattern of adverse events has been observed in children, adolescents, or the elderly.(1)

It is not known how renal or liver impairment can affect the metabolism of Daily Essential Nutrients.



**Refers to Truehope EMPowerplus which was co-formulated by David Hardy. Truehope EMPowerplus is a registered trademark of The Synergy Group of Canada Inc.