Clinical trial NCT05232266: The Effectiveness of a Caralluma Fimbriata Extract on Stress, Sleep and Neurotransmitters
Official title: The Effectiveness of a Caralluma Fimbriata Extract on Stress, Sleep and Neurotransmitters, a Randomised Placebo-controlled Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stress
Sleep
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2022-02-09
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years and above
* Self-reporting Stress
* Able to provide informed consent
* Agree not to change current diet and exercise program while enrolled in this trial
* Agree not to undertake another clinical trial while enrolled in this trial

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.

    * Potential participants that are taking supplements that would result in their exclusion must wait a 4-week washout period prior to commencing the study.

Primary outcomes:
measure: Change in stress as assessed by Perceived Stress Scale (PSS)
timeFrame: Baseline prior to commencement of study product, Week 4 and Week 8
measure: Change in stress as assessed by Salivary Cortisol levels
timeFrame: Baseline prior to commencement of study product, Week 4 and Week 8
Secondary outcomes:
measure: Change in stress and mood as assessed by the Profile of Mood States (POMS) scale
timeFrame: Baseline prior to commencement of study product, Week 4 and Week 8
measure: Change in stress and mood as assessed by The Depression, Anxiety Stress Scale -21 (DASS-21)
timeFrame: Baseline prior to commencement of study product, Week 4 and Week 8
measure: Change in sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline prior to commencement of study product, Week 4 and Week 8
measure: Change in sleep as measured by the Restorative Sleep Questionnaire (RSQ)
timeFrame: Baseline prior to commencement of study product, Week 4 and Week 8
measure: Change in Neurotransmitters as assessed by pathology
timeFrame: Baseline prior to commencement of study product, Week 4 and Week 8
Other outcomes:
Locations:
city: Newstead
country: Australia
facility: RDC Clinical Pty Ltd
state: Queensland
Study officials:
affiliation: RDC Clinical Pty Ltd
name: Amanda Rao, PhD
role: PRINCIPAL_INVESTIGATOR
References: