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Double-Blind Study: Daily Essential Nutrients Helps Mood, Behavior
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A new study, “Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youth: A Placebo-Controlled Randomized Clinical Trial,” was published online July 22, 2021, ahead of print in the world-renowned Journal of the American Academy of Child & Adolescent Psychiatry. This landmark study is the third double-blind, placebo-controlled trial to independently investigate the effectiveness of a clinical-strength multinutrient formula called Daily Essential Nutrients.
The study was funded through private donations to the Nutrition and Mental Health Research Fund managed by the Foundation for Excellence in Mental Health Care (FEMHC) plus a direct grant from FEMHC and from the Gratis Foundation. The authors also received support from the National Institutes of Health (NIH) National Center for Complementary and Integrative Health.
The study was approved by Institutional Review Boards at Oregon Health & Science University, The Ohio State University, the Conjoint Health Research Ethics Board at the University of Calgary for the University of Lethbridge; the US Food and Drug Administration, and Health Canada, and was registered prospectively with the National Clinical Trials Registry.
The researchers involved in carrying out the research are associated with Ohio State University, Nationwide Children's Hospital, Oregon Health & Sciences University, and the University of Lethbridge.
The study set out to evaluate whether a specialized blend of micronutrients called Daily Essential Nutrients, formulated by Hardy Nutritionals, benefits unmedicated children ages 6-12 with ADHD and irritability.
Some of the ADHD symptoms targeted with the micronutrient treatment included focus, oppositional defiance, disruptive mood dysregulation, and peer conflict symptoms.
The double-blind, randomized, placebo-controlled trial design ensured that participants, their parents, clinicians, and researchers did not know who received the micronutrients or a placebo. This design is considered the "gold standard" of research.
The results: Daily Essential Nutrients showed significant overall benefit over placebo in children with ADHD and irritability. The formulation was deemed safe and effective by researchers. There were impressive behavioral and mood-related findings, plus, the micronutrient group showed greater height growth than the placebo group—illustrating a powerful and statistically meaningful overall health effect of the nutritional approach. The children taking the specialized blend of micronutrients from Hardy Nutritionals showed no differences in side effects compared to placebo, which bodes well for those who cannot tolerate pharmaceutical treatments for ADHD, due to often severe side effects.
The primary outcome amongst the micronutrient group was "very much" or "much" improved after the 8-week study period.
The study found improvements in:
Anxiety
Aggression
Irritable Mood
Emotional Regulation
Sleep
Anger
Participants in the micronutrient group taking Daily Essential Nutrients were three times as likely to be treatment responders (show improvement in symptoms) than those in the placebo group based on blind clinician ratings. There was also a significant difference favoring the micronutrients group measuring aggression towards peers, compared to placebo.
Researchers stated, “The micronutrient treatment was both acceptable and well-tolerated, with a 93% retention rate...This finding is consistent with previous micronutrient studies.”
This particular double-blind study comes on the heels of two previous double-blind studies also carried out on Hardy Nutritionals’ Daily Essential Nutrients, as well as many non-blinded micronutrient studies, which all showed marked improvements in study participants, including for symptoms such as anger and irritability.
All micronutrient studies conducted to date, demonstrate clearly that nutrition status directly impacts mental health. The researchers believe given the improvements shown in participants who used the micronutrients for ADHD symptoms and given that Omega-3 supplementation is also shown to benefit those with ADHD, combining the two treatment methods should also be studied further.
There are currently three additional double-blind studies underway specifically on Daily Essential Nutrients for mood and anxiety.
The study was funded through private donations to the Nutrition and Mental Health Research Fund managed by the Foundation for Excellence in Mental Health Care (FEMHC) plus a direct grant from FEMHC and from the Gratis Foundation. The authors also received support from the National Institutes of Health (NIH) National Center for Complementary and Integrative Health.
The study was approved by Institutional Review Boards at Oregon Health & Science University, The Ohio State University, the Conjoint Health Research Ethics Board at the University of Calgary for the University of Lethbridge; the US Food and Drug Administration, and Health Canada, and was registered prospectively with the National Clinical Trials Registry.
The researchers involved in carrying out the research are associated with Ohio State University, Nationwide Children's Hospital, Oregon Health & Sciences University, and the University of Lethbridge.
The study set out to evaluate whether a specialized blend of micronutrients called Daily Essential Nutrients, formulated by Hardy Nutritionals, benefits unmedicated children ages 6-12 with ADHD and irritability.
Some of the ADHD symptoms targeted with the micronutrient treatment included focus, oppositional defiance, disruptive mood dysregulation, and peer conflict symptoms.
The double-blind, randomized, placebo-controlled trial design ensured that participants, their parents, clinicians, and researchers did not know who received the micronutrients or a placebo. This design is considered the "gold standard" of research.
The results: Daily Essential Nutrients showed significant overall benefit over placebo in children with ADHD and irritability. The formulation was deemed safe and effective by researchers. There were impressive behavioral and mood-related findings, plus, the micronutrient group showed greater height growth than the placebo group—illustrating a powerful and statistically meaningful overall health effect of the nutritional approach. The children taking the specialized blend of micronutrients from Hardy Nutritionals showed no differences in side effects compared to placebo, which bodes well for those who cannot tolerate pharmaceutical treatments for ADHD, due to often severe side effects.
The primary outcome amongst the micronutrient group was "very much" or "much" improved after the 8-week study period.
The study found improvements in:
Anxiety
Aggression
Irritable Mood
Emotional Regulation
Sleep
Anger
Participants in the micronutrient group taking Daily Essential Nutrients were three times as likely to be treatment responders (show improvement in symptoms) than those in the placebo group based on blind clinician ratings. There was also a significant difference favoring the micronutrients group measuring aggression towards peers, compared to placebo.
Researchers stated, “The micronutrient treatment was both acceptable and well-tolerated, with a 93% retention rate...This finding is consistent with previous micronutrient studies.”
This particular double-blind study comes on the heels of two previous double-blind studies also carried out on Hardy Nutritionals’ Daily Essential Nutrients, as well as many non-blinded micronutrient studies, which all showed marked improvements in study participants, including for symptoms such as anger and irritability.
All micronutrient studies conducted to date, demonstrate clearly that nutrition status directly impacts mental health. The researchers believe given the improvements shown in participants who used the micronutrients for ADHD symptoms and given that Omega-3 supplementation is also shown to benefit those with ADHD, combining the two treatment methods should also be studied further.
There are currently three additional double-blind studies underway specifically on Daily Essential Nutrients for mood and anxiety.
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