Carbohydrates, protein, fat, and water are known to be essential to humans and are required in quantities that make up a substantial portion of dietary intake. Vitamins and minerals are also essential nutrients, but they are required in comparatively small quantities. These “micronutrients” exert an influence on human health which is dramatically larger than their proportion of dietary intake.

At Hardy Nutritionals, we have learned that these essential micronutrients — that is, vitamins and minerals — not only have a substantial influence on physical health, but they also play an outsized role in mental health and wellbeing. 

Hardy Nutritionals offers two different product lines of broad-spectrum micronutrients: Daily Essential Nutrients and Optimal Balance. 

Daily Essential Nutrients was developed for mental health symptoms of a severe or debilitating nature — those which often require clinical attention. DEN for short, this formula is intended to be taken in high doses, preferably under health professional oversight. The DEN formula is the most extensively researched and sought after of the two, due to its having clinical applications and efficacy which rivals the best treatments that psychiatry has to offer. It is also backed by multiple independent university studies which have been peer-reviewed and published in reputable medical journal publications.

Optimal Balance is similar in concept and formulation but differs in dose. Although it also delivers statistically significant benefits on mental health outcome measures and has also been studied in academic research, at the recommended dose it is not capable of the same therapeutic power as Daily Essential Nutrients. The primary reason for carrying two separate products is for marketing: one provides high doses oriented towards severe symptoms of clinical gravity, and one competes with other daily multivitamins. Optimal Balance is oriented towards gender-differentiated branding and lower doses geared towards the milder mental health deficits —such as occasional mood dysregulation and mild stress—which plague a larger percentage of people to a lesser degree and for which many individuals might not seek clinical treatment. 

So what makes the Hardy Nutritionals micronutrient formulas so special? The most unique thing about Daily Essential Nutrients is probably the amount of independent, academic research to which it has been subjected and the incredible efficacy it has demonstrated under rigorous scrutiny. Not only is it the most research-backed micronutrient supplement to date; the physical composition stands out among other multivitamins.

Unlike most of its competitors, the DEN formula contains all known essential vitamins and minerals except sodium. It also contains extensive additional trace minerals and a few other nutrients, amino acids, antioxidants, and botanicals. Some of the best nutrition researchers of the last century have published opinions and reviews concluding that the evidence is clear that supplying a broad-spectrum of essential nutrients has much more treatment power compared to single-nutrient or “magic bullet” supplements. 

In attempting to understand the efficacy of Daily Essential Nutrients in a double-blind, placebo-controlled trial, the researchers and authors cited renowned USDA nutrition researcher Walter Mertz:

“While a multinutrient approach challenges conventional psychiatric research practices that favor manipulating one variable at a time, a single nutrient strategy is at odds with human physiology, as optimal functioning requires the presence of a wide range of nutrients consumed in balance, rather than one nutrient provided in high doses (Mertz, 1994).” [1]

The processes in the brain that produce essential enzymes, hormones, and neurotransmitters are reliant on sufficient doses of dozens of micronutrients. When taking a single-nutrient approach, the brain is still missing vital nutrients to complete these brain processes. 

In addition to its comprehensive breadth, DEN is unique in its carefully balanced inter-nutrient ratios. This can be seen in the widely varying percent daily values on the supplement facts panel of the label. Many supplements are formulated to deliver nice even daily value percentages. However, the reality is that the percent daily value is based on single nutrient research only instead of a comprehensive, broad-spectrum approach. This means that 100% daily value does not represent a target for optimized health or recovery from illness but rather it targets the prevention of outright deficiency in otherwise healthy individuals. In contrast, DEN has been carefully formulated for safety and efficacy, regardless of what the label might look like.

Not only is the nutrient ratio optimized for best results in a broad-spectrum supplement, but Hardy Nutritionals formulas are also different in the chemical composition of the nutrients themselves. Since the discovery and classification of vitamins, we have learned that some exist as a group of molecules — all of which share the same essential functions in the body —rather than a single substance. We have carefully selected the forms of vitamins we use in our formulas, but over the years we have learned that the minerals are perhaps even more important. Minerals are basic elements that cannot be synthesized. Plants, many microorganisms, and even some of the larger animals can synthesize their own vitamins, but minerals must always be ingested dietarily. However, because minerals are bulky, expensive (at least in their bioavailable forms), and taste bad, very few supplements provide therapeutically relevant quantities of these essential minerals. We have learned over the years that the minerals are especially critical to the mood-regulating properties of Daily Essential Nutrients. In our formula, we chelate the minerals we use with our own proprietary NutraTek process for improved bioavailability and provide clinically relevant doses of all of them.  

There is no doubt as to the therapeutic value of this formula.  A wealth of research has now validated the wisdom of meeting the complexity and interconnectedness of the body’s metabolic pathways with this broad-spectrum approach to supplementation.

Although the neurological dysfunction underlying mood and behavioral disorders is as physiologically real as a broken arm, the brain is not nearly so visible. This may give rise to stigma and confusion. Effective micronutrient therapy dispels much of the mystery & fear around mental illness by offering a physiological explanation for what otherwise remains a purely descriptive and seemingly subjective diagnosis of emotions and behaviors. It allows for re-integration of self for many who previously had to dissociate themselves from their emotions and behaviors because they could not control them, and/or they did not understand them, and/or they did not even match their values.

RESEARCH

Most supplement companies lucky enough to have independent, third-party research on their products can tout at most one or two clinical trials. We have many. Most supplements have very targeted uses, going back to the single-nutrient-based strategies used by many formulators. In contrast, the breadth of clinical applications for the same micronutrient therapy is staggering.  Even more impressively, the efficacy of Hardy Micronutrient Therapy in clinical trials is better than most of the available treatments in psychiatry and the side effect profile is next to none. 

In total, there have been three double-blind randomized placebo-controlled trials, three randomized placebo-controlled trials, 26 observational studies, three safety studies, four mechanistic studies, and four double-blind randomized placebo-controlled trials are currently underway, all in which the effectiveness of Hardy Nutritionals has been or is being researched. Some of the topics of these studies include adult ADHD with comorbid depression, pediatric ADHD with comorbid anxiety, bipolar disorder, Autism Spectrum Disorders, and insomnia. You can find full-text links to the articles here.

CLINICAL APPLICATION

Through these studies, we are able to identify what types of benefits people experience the most from DEN. While the list is extensive, some of the main benefits relate to improved cognition, improved sense of well-being, better mood and mood stability, improved emotional control, and improved attention. Overall, we consistently see less brain fog, reduced anxiety and stress, decreased depression and mood swings, fewer outbursts of aggression, irritability, and defiance among those diagnosed with ASD and ODD, as well as decreased hyperactivity in those diagnosed with ADHD. 

We believe that DEN and broad-spectrum micronutrient therapy can be beneficial for most people who experience mood disorders or various psychiatric conditions. From post natural disaster trauma to ADHD to bipolar disorder, DEN has helped improve symptoms of those dealing with these conditions. While individuals should always consult their physicians, we see DEN and micronutrient supplementation as a future for managing symptoms of various psychiatric conditions with few to no side effects. 

DOSING

While the most rigorously studied dose is 12 capsules per day, the dosing in peer-reviewed clinical trials ranges from a minimum of four capsules per day to 16 capsules per day on the high end. Most dosing depends on the severity of the symptoms being treated. And yet, in spite of these huge capsule counts, daily intake is still well within safe ranges and is well tolerated. At Hardy Nutritionals, we have learned that the minimalist approach to nutrition —- assumed by many, with hardly any critical thought, to be the ideal approach —- has left untapped the huge range of nutrient intake above the minimal intake requirements which is therapeutically useful while still being completely safe.

For adults, the recommended dose is a four-per-day working up to 12 capsules per day. Anecdotally, we see continued improvement for about three years. For those who see any benefit from DEN within the first six months, we recommend at least three years at their most efficacious clinical dose before reducing to a maintenance dose. Some more severe symptoms and diagnoses may require doses up to 16 capsules a day and therefore may also require more than three years to reach peak effectiveness before dropping to a maintenance dosage. 

For children, safe and effective dosing has been shown to be independent of age or weight. Because essential nutrients such as vitamins and minerals are not foreign to the body like other pharmacological medications and treatments, risk of harm from DEN does not increase across the dosing curve. Perhaps counterintuitively, the doses for children can be comparable to adult doses due to the low risk of harm and the high metabolic rate of children. Even though all doses can vary between individuals, research has shown a recommended daily dosage for children of various ages as follows:

Children aged seven and up: 12 capsules a day 

Children aged five to six: up to 10 capsules a day

Children aged four to five: up to eight capsules a day

Children ages four and under: up to six capsules a day

Just as with adults, children are recommended to work up to the full dose by one capsule a day as tolerated until the effective dosage is reached.

Many years of clinical trials and careful observation and follow-up have revealed that while micronutrient therapy feels to many patients like a cure where they experience decreased symptoms with virtually no side effects, DEN does not claim to be a cure. Treatment outcomes are almost always multifactorial. Results are at least a function of dose as well as duration of treatment. Often lifestyle choices, concurrent medication use, digestive health, and other variables are at play. 

SIDE EFFECTS & SAFETY

Amongst psychiatric treatments, DEN is uniquely safe in its list of side effects. While the side effects of DEN are minimal when used as monotherapy, the most common negative effects occur when DEN is combined with psychiatric medications. When someone uses DEN as supplementation alongside other medications, they may experience exacerbated side effects of their medications due to Daily Essential Nutrients potentiating the drug’s action in their body. Those who report these symptoms incorrectly assume they are side effects from Daily Essential Nutrients when in reality, they are drug interaction effects instead of nutrient side effects. As the micronutrient therapy continues for those who combine DEN with medications, the dosing of medications will need to be appropriately reduced to attenuate the amplification effect of the potentiated drugs.

Even at 12 capsules per day, DEN dosing is comfortably below the adult upper limit (UL) for most nutrients, well centered between the risk of deficiency and the risk of toxicity. In fact, at 12 capsules per day only magnesium, niacin, and zinc exceed the North American UL’s. Many of the other nutrients are well below the UL, which is reflected in vitamin and mineral averages comfortably centered in the theoretically safest intake range — well above minimal requirement and comfortably below the UL.

Here is a comprehensive list of the side effects of Daily Essential Nutrients. These side effects tend to be rare, infrequent, and transitory:

• Headache
• Nausea
• Insomnia
• Loose stools
• Urine colored bright neon yellow

“...the most common adverse effects reported were headaches and nausea.  These effects were transient and resolved through advice to take micronutrients with food and water.”[2]

“Sleep initiation problems that emerged were addressed by ensuring pills were taken at least two hours prior to bedtime, as B vitamins can be quite activating.”[3]

Hardy Nutritionals’ micronutrient formulations are the world’s most research-backed vitamin-mineral supplements for mood and mental health. Recommended by health professionals worldwide and studied by universities on multiple continents, Hardy formulations stand apart as the first line of defense against psychiatric disorders. The formulations are shown to be safe and effective as well as cost-efficient when compared to long-term psychiatric treatments and facility costs. Training and consultations for health professionals is available at https://try.hardynutritionals.com/clinical-resources/. Support for patients is also available at https://try.hardynutritionals.com/getting-started/. 

References

[1] Rucklidge JJ, Eggleston MJF, Johnstone JM, Darling K, Frampton CM.  Vitamin-mineral treatment improves aggression and emotional regulation in children with ADHD: a fully blinded, randomized, placebo-controlled trial. J Child Psychol Psychiatry. 2018 Mar; 59(3):232-246. 

[2] Julia J. Rucklidge, PhD, Matthew J. F. Eggleston, MD, Breanne Ealam, BA (Hons), Ben Beaglehole, MD, and Roger T. Mulder, MD. An Observational Preliminary Study on the Safety of Long-Term Consumption of Micronutrients for the Treatment of Psychiatric Symptoms. J Altern Complement Med. 2019 Jun;25(6):613-622.

[3] Rucklidge JJ, Eggleston MJF, Johnstone JM, Darling K, Frampton CM.  Vitamin-mineral treatment improves aggression and emotional regulation in children with ADHD: a fully blinded, randomized, placebo-controlled trial. J Child Psychol Psychiatry. 2018 Mar; 59(3):232-246.

About Hardy Nutritionals®

Hardy Nutritionals® multivitamin-mineral products are powered by our proprietary NutraTek™ mineral delivery technology, which combines each mineral with specialized organic molecules—just like nature—to optimize absorption and distribution to body cells. Our flagship supplement, Daily Essential Nutrients, is widely considered to be the most research-backed micronutrient treatment.