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.
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.
