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Mechanism
of Action
Relora is an exciting new natural anti-anxiety stress relief ingredient
to control stress related eating and drinking that has the added value
of being non-sedating with potential anti-depressant properties. In central
nervous system receptor binding essays, the plant extracts in Relora bind
to several important targets associated with anxiety. It does not bind
to the benzodiazepine receptors that would cause sedation, yet has the
relaxing qualities of the benzodiazepine class of drugs in a validated
anxiolytic animal model. In addition, it normalizes hormone levels associated
with stress-induced obesity and eating/drinking behavior.
Stress is
being shown to lay a significant role in a wide variety of conditions
and disease states. Recent work from the National Institute of Health
(NIH) and other major research centers has demonstrated that stress is
a significant contributor to immune dysfunction, cardiovascular disease,
other age-related disorders, and to excessive body fat. Over 20% of adults
have an obesity-like condition characterized by excessive abdominal fat.
This condition is related to stress-induced hormone imbalances, especially
imbalances of cortisol and DHEA. Until now, the only course of action
for losing this fat has been stress reduction with exercise and diet.
Relora can normalize cortisol and DHEA levels in stressed individuals,
induce relaxation, and act as an aid in controlling weight and stress
related eating and drinking.
Human Trials
The first formulation of Relora was tested and found to be a safe, effective,
rapid acting, non-sedating dietary supplement that helps control mild
anxiety. Fifty subjects were treated with Relora for two weeks. The recommended
dosage was 200mg. of Relora three times daily (the new and improved Relora
dosage is 250mg. three times daily). Based on the pre-clinical studies,
Relora was designed and evaluated against the following concepts: "Relora
helps control occasional mild anxiety or mild depression and the associate
symptoms: irritability; emotional ups and downs; restlessness; tense muscles;
poor sleep; and concentration difficulties." Post-trial analysis
revealed an excellent agreement (82%) with the pretrial concept. Relaxation
was reported by 78% of the patients. Though the product does not cause
significant sedation, 74% of the patients had a restful sleep. No significant
side effects were reported. When subjects were asked about drowsiness,
only 24% reported they were drowsy. Relora was judged to be gentle on
the stomach by 94% of the subjects. A second trial was undertaken to measure
cortisol and DHEA levels in patients with mild to moderate stress. Elevated
cortisol levels and depressed DHEA levels are associated with chronic
stress. A two-week regimen of Relora caused a significant (P=0.003) increase
in salivary DHEA (227%) and significant findings support Relora's ability
to relieve stress and its potential role in weight control and stress-related
eating and drinking behavior. A clinical trial on the final formulation
is expected to be complete in 2002.
Animal Model
The plant extracts in Relora have been shown to be an effective non-sedating,
anti-stress product in an animal model known as the "Chick Social
Separation-Stress Procedure." This model has been validated for the
benzodiazepine class of anti-anxiety drugs. The excellent results of the
patent-pending extracts in Relora using this model were published in Psychopharmacology
(2001) 153:219-234.
Safety Studies
An extensive literature review of the chemical constituents along with
the parent plants' use for hundreds of years indicates that this material
is safe for its intended use. An acute toxicity study in rats (5g/Kg)
with 14-day observation revealed no untoward effects of the individual
experts or the combination in Relora except mild diarrhea and slight sedation
in female rats. No side effects are expected at the recommended human
dosage.
This
statement has not been evaluated by the Food & Drug Administration
(FDA). This product is not intended to diagnose, cure or prevent any disease.
LifeTime
Warranty:
Our products
are manufactured to meet strict quality control standards and formulated
using only quality industry acceptable materials.
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