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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caralluma fimbriata | Experimental | Caralluma fimbriata in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food. |
|
| Placebo comparator capsule - Microcrystalline cellulose | Placebo Comparator | A comparator capsule taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caralluma Fimbriata | Drug | Caralluma fimbriata in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Baseline prior to commencement of study product, Week 4 and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Baseline prior to commencement of study product, Week 4 and Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
Unstable or serious illness (e.g. Serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, thyroid gland dysfunction)*
Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years
Receiving/prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy
Receiving treatment for anxiety, or taking supplements# for anxiety or sleep conditions such as saffron, valerian, etc.
Active smokers, nicotine use, alcohol or drug (prescription or illegal substances) abuse
Chronic past and/or current alcohol use (>14 alcoholic drinks week)
Allergic to any of the ingredients in the active or placebo formula
Known pregnant or lactating woman
Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
Participants who have participated in any other related clinical study during the past 1 month
History of infection in the month prior to the study
An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Rao, PhD | RDC Clinical Pty Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical Pty Ltd | Newstead | Queensland | 4006 | Australia |
No IPD will be shared
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| Placebo comparator - Microcrystalline cellulose | Drug | Placebo comparator in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food. |
|
| 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. | 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. | Baseline prior to commencement of study product, Week 4 and Week 8 |
| Change in sleep as measured by the Restorative Sleep Questionnaire (RSQ) | 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. | 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 | Baseline prior to commencement of study product, Week 4 and Week 8 |