Mood Disorders Clinical Trial
Official title:
ACUTE AND CHRONIC EFFECTS OF A PROPRIETARY BOTANICAL EXTRACT ON ANXIETY, PERCEIVED STRESS, MOOD AND CORTISOL SECRETION AND METABOLISM IN HEALTHY ADULTS: RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND CLINICAL TRIAL
Mood disorders, including depression and anxiety, are one of the main causes of the overall
disease burden worldwide.
In recent years, the efficacy of certain botanicals as an alternative solution for depression
has been evaluated in a number of clinical trials.
However, only few studies looked at the effects of these botanicals on mood in healthy
subjects.
The aim of the proposed randomised, double-blind, placebo-controlled, parallel groups
methodology is to assess the acute and chronic effects of daily supplementation with a
proprietary and standardized botanical extract in comparison to placebo in healthy adults
aged 18-60 years with self-reported low mood.
The chronic effect of the active product on mood, anxiety, perceived stress, quality of life
and cortisol secretion & metabolism will be assessed through validated questionnaires and
urine collection after 2, 4 and 8 weeks of daily supplementation.
The acute effect of the product will be assessed after a single dose and exposure to an acute
psychological stressor. Before, during and after the stressor, saliva samples will be
collected and subjective levels of anxiety and mood will be measured. In addition, Galvanic
Skin Response (GSR) and heart rate (HR) will be measured throughout the stressor session.
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