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Clinical Trial Study


Participants

20 participants were recruited and divided into two groups according to gender -- 11 women and 9 men. The data sub-divides these groups (post-testing) based on placebo vs. active ingredients.


Product ingredients

Proprietary blend of Glutamine, L-tyrosine, Velvet bean extract (Mucuna pruriens), Griffonia simplicifolia extract (5-Hydroxytryptophan), and pyridoxine (Vitamin B-6). These components make up the precursor pathways to both dopamine and serotonin. They are delivered in a flavored dissolving lozenge base of sucralose and isomalt.

Placebo Lozenge contained only: flavoring, sucralose, and isomalt


Test Methodology

Double blinded study. Product lozenge vs. placebo lozenge. The study arbitrarily assigned each participant either the product lozenge or the placebo lozenge. Each participant completed a medical history, current medication and dietary supplement form. Participants were instructed to avoid taking all medications, vitamins, or supplements on the day of the study until they had completed the study. No food was permitted and only water was allowed for consumption until completion of the study.

Each participant provided a Pre-Dose morning urine collection (second void of the morning). Then subjects orally dissolved their assigned testing lozenge (placebo or active). Participants drank only water and ate no food until they completed their final Post-Dose urine collection over the next 2 hours.

All urine samples were labeled and frozen in the lab-provided vials and submitted to a nationally accredited neurotransmitter testing laboratory by UPS overnight delivery. All samples were submitted for measurement of dopamine and serotonin.

Collection of urine specimens for study followed the protocol provided by the neurotransmitter testing laboratory. The references for normal neurotransmitter levels were previously determined by the laboratory.


Neurochemical Background

Baseline urinary excretion levels of the neurotransmitters reflect a central peripheral equilibrium. This means that initial low levels of neurotransmitters measured in the urine (peripheral) directly reflect low reservoir levels of neurotransmitters in the brain (central). The lower the urinary amount, the more deficient a person is in brain neurotransmitters. With the addition of neurotransmitter enhancing compounds, referred to as neurotransmitter precursor therapy, levels of neurotransmitters measured in the urine rise. This rise also indicates increased central (brain) synthesis of neurotransmitters.


Results

The summary of the results is as follows:

Placebo groups: All placebo patients obtain results within a very narrow range, showing very little, if any effect.

Product lozenge (active ingredients) group demonstrated an average 819% rise in both serotonin and 425% rise in dopamine levels.

Please refer to the following chart and graphs.

Dopamine Chart
Click Chart to Enlarge


Seratonin Chart
Click Chart to Enlarge


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