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

Phase 2

Completed

• Conditions: Stress; Sleep
• Interventions: Drug: Caralluma Fimbriata; Drug: Placebo comparator - Microcrystalline cellulose

• Registration Number: NCT05232266
• Lead Sponsor: RDC Clinical Pty Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-30
• Study First Posted: 2022-02-09
• Study Start: 2022-02-10
• Primary Completion: 2023-05-19
• Study Completion: 2023-05-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-22
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caralluma fimbriata	Caralluma Fimbriata	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 - Microcrystalline cellulose	A comparator capsule taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food.

Primary Outcome Measures

Name	Time	Method
Change in stress as assessed by Perceived Stress Scale (PSS)	Baseline prior to commencement of study product, Week 4 and Week 8	Change in stress as assessed by Perceived Stress Scale (PSS) - Score range 0-40, Higher scores indicate higher perceived stress.
Change in stress as assessed by Salivary Cortisol levels	Baseline prior to commencement of study product, Week 4 and Week 8	Change in stress as assessed by Salivary Cortisol levels through assay

Secondary Outcome Measures

Name	Time	Method
Change in stress and mood as assessed by the Profile of Mood States (POMS) scale	Baseline prior to commencement of study product, Week 4 and Week 8	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".
Change in Neurotransmitters as assessed by pathology	Baseline prior to commencement of study product, Week 4 and Week 8	Change in neurotransmitters Serotonin, Dopamine, oxytocin, nor-epinephrine, adrenalin, glutamate and GABA as assessed by pathology
Change in sleep as measured by the Restorative Sleep Questionnaire (RSQ)	Baseline prior to commencement of study product, Week 4 and Week 8	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.
Change in stress and mood as assessed by The Depression, Anxiety Stress Scale -21 (DASS-21)	Baseline prior to commencement of study product, Week 4 and Week 8	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.
Change in sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)	Baseline prior to commencement of study product, Week 4 and Week 8	Change in sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI) which covers 7 domains with higher scores indicating poorer sleep quality.

Trial Locations

Locations (1)

RDC Clinical Pty Ltd; 🇦🇺 Newstead, Queensland, Australia