The Effectiveness of a Caralluma Fimbriata Extract on Stress, Sleep and Neurotransmitters

The Effectiveness of a Caralluma Fimbriata Extract on Stress, Sleep and Neurotransmitters, a Randomised Placebo-controlled Double-blind Study

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 Overview

• Status: Completed
• Conditions: Stress; Sleep
• Intervention / Treatment: Drug: Caralluma Fimbriata; Drug: Placebo comparator - Microcrystalline cellulose

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Newstead, Queensland, Australia, 4006
      • RDC Clinical Pty Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caralluma fimbriata; Caralluma fimbriata in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food.	Drug: Caralluma Fimbriata; Caralluma fimbriata in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food.; Other Names: C.fimbriata
Placebo Comparator: Placebo comparator capsule - Microcrystalline cellulose; A comparator capsule taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food.	Drug: Placebo comparator - Microcrystalline cellulose; Placebo comparator in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: RDC Clinical Pty Ltd
• Investigators: Principal Investigator: Amanda Rao, PhD, RDC Clinical Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Actual): May 19, 2023
• Study Completion (Actual): May 19, 2023

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: January 30, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 22, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CARSTA-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No