Breakthrough Phase One Clinical Trial

SpectrumNeeds® Plus QNeeds® Show Major Improvements in Autism

In a groundbreaking double-blind, placebo-controlled, crossover study, entitled “A Mitochondrial Supplement Improves Function and Mitochondrial Activity in Autism,” published in the International Journal of Molecular Sciences, has demonstrated significant improvements in both mitochondrial function and core autism symptoms in children using SpectrumNeeds® and QNeeds®.

The Challenge

Autism is increasingly common, affecting 1 in 36 children according to the CDC. Until now, there has been no proven treatment for core autism challenges such as communication difficulties, social struggles, and repetitive behaviors. Current FDA-approved medications (Aripiprazole/Abilify and Risperidone/Risperdal) and applied behavioral therapy (ABA) only address symptoms, not underlying causes.

The Link to Mitochondrial Function

Research suggests that 80% or more of individuals with autism have some level of mitochondrial dysfunction that reduces cellular energy production and may contribute to autism symptoms. Finding a treatment that restores mitochondrial function could have a major impact on improving autism-related challenges. Until now, no supplement has been scientifically proven to improve both mitochondrial function and autism symptoms.

The Study

Renowned autism researcher Dr. Richard Frye led a clinical trial on 16 children (ages 2–17) with autism to test the effects of SpectrumNeeds® and QNeeds®. Participants took either the supplement (SpectrumNeeds® and QNeeds®) or a placebo (matching in look, smell, and taste). After 3 months, the groups switched so that all participants eventually received both supplement and placebo. This double-blind, placebo-controlled, crossover study is considered the gold standard in medical research.

The study was funded by the Brain Foundation and XEL Foundation, with NeuroNeeds® providing the supplement and placebo.

The Results

Well-Tolerated

No major side effects were observed, only a mild decrease in appetite in some cases.

Improved Mitochondria Function

On SpectrumNeeds® and QNeeds®, children showed significantly improved mitochondrial function (measured using MitoSwab and Seahorse tests).

Notably, respiratory capacity (RC) improved, suggesting better resilience against environmental stressors like viruses and chemicals.

Significant Clinical Improvements

Children taking the supplement saw meaningful improvements in all three core autism areas:

Verbal communication
Social skills
Behavior (including hyperactivity)

Conclusion & Next Steps

This study is the first to show a natural treatment, SpectrumNeeds® and QNeeds®, improved both mitochondrial function and core autism symptoms. While the trial was small (16 children), the results were highly encouraging.

A larger study with 120 children is planned to further validate these findings.

Read a summary of the phase one clinical trial results.

The content within this article and NeuroNeeds® blog is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this blog.

Articles, Blog