This is a double blind, randomised, placebo-controlled clinical trial aiming to assess the effectiveness of Caralluma fimbriata on stress, sleep and neurotransmitters in a healthy adult population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
129
Caralluma fimbriata in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food.
Placebo comparator in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food.
RDC Clinical Pty Ltd
Newstead, Queensland, Australia
Change in stress as assessed by Perceived Stress Scale (PSS)
Change in stress as assessed by Perceived Stress Scale (PSS) - Score range 0-40, Higher scores indicate higher perceived stress.
Time frame: Baseline prior to commencement of study product, Week 4 and Week 8
Change in stress as assessed by Salivary Cortisol levels
Change in stress as assessed by Salivary Cortisol levels through assay
Time frame: Baseline prior to commencement of study product, Week 4 and Week 8
Change in stress and mood as assessed by the Profile of Mood States (POMS) scale
Change in stress as assessed by Profile of Mood States (POMS) scale - Six dimensions including Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment assessed ona five point scale ranging from "not at all" to "extremely".
Time frame: Baseline prior to commencement of study product, Week 4 and Week 8
Change in stress and mood as assessed by The Depression, Anxiety Stress Scale -21 (DASS-21)
Change in stress as assessed by DASS-21 - A set of three self-reported scales to measure emotional states of depression, anxiety and stress. Each scale contains 7 items.
Time frame: Baseline prior to commencement of study product, Week 4 and Week 8
Change in sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Change in sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI) which covers 7 domains with higher scores indicating poorer sleep quality.
Time frame: Baseline prior to commencement of study product, Week 4 and Week 8
Change in sleep as measured by the Restorative Sleep Questionnaire (RSQ)
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Change in sleep as assessed by the Restorative Sleep Questionnaire (RSQ) which has 9 items scaled from 1-5. Higher total scores indicate a more restorative sleep.
Time frame: Baseline prior to commencement of study product, Week 4 and Week 8
Change in Neurotransmitters as assessed by pathology
Change in neurotransmitters Serotonin, Dopamine, oxytocin, nor-epinephrine, adrenalin, glutamate and GABA as assessed by pathology
Time frame: Baseline prior to commencement of study product, Week 4 and Week 8