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

NCT05232266 | Completed Phase 2

• 1 other identifier: CARSTA-21
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Sleep

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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 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 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 measured by the Restorative Sleep Questionnaire (RSQ)

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

• Change in Neurotransmitters as assessed by pathology

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

Study Arms (2)

Caralluma fimbriata

EXPERIMENTAL

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

Drug: Caralluma Fimbriata

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.

Drug: Placebo comparator - Microcrystalline cellulose

Interventions

Caralluma Fimbriata DRUG

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

Also known as: C.fimbriata

Caralluma 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.

Placebo comparator capsule - Microcrystalline cellulose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead

Study Sites (1)

RDC Clinical Pty Ltd

Newstead, Queensland, 4006, Australia

Location

Study Officials

• Amanda Rao, PhD

  RDC Clinical Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 9, 2022
• Study Start: February 10, 2022
• Primary Completion: May 19, 2023
• Study Completion: May 19, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)