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NCT Number: NCT05232266

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

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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Key information

Conditions

Stress Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

RDC Clinical Pty Ltd

Newstead, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caralluma Fimbriata

Drug

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 - Microcrystalline cellulose

Drug

Placebo comparator in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food.

Primary outcomes

  1. Change in stress as assessed by Perceived Stress Scale (PSS)

    Time frame: 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.

  2. Change in stress as assessed by Salivary Cortisol levels

    Time frame: Baseline prior to commencement of study product, Week 4 and Week 8

    Change in stress as assessed by Salivary Cortisol levels through assay

Secondary outcomes

  1. Change in stress and mood as assessed by the Profile of Mood States (POMS) scale

    Time frame: 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".

  2. Change in stress and mood as assessed by The Depression, Anxiety Stress Scale -21 (DASS-21)

    Time frame: 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.

  3. Change in sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)

    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) which covers 7 domains with higher scores indicating poorer sleep quality.

  4. Change in sleep as measured by the Restorative Sleep Questionnaire (RSQ)

    Time frame: 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.

  5. Change in Neurotransmitters as assessed by pathology

    Time frame: 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

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 9, 2022
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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