Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000014550
Ethics application status
Approved
Date submitted
6/12/2023
Date registered
10/01/2024
Date last updated
20/05/2024
Date data sharing statement initially provided
10/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The acute effects of capsaicin on metabolism and thermogenesis in healthy adult females – a clinical trial
Scientific title
The acute effects of capsaicin supplements on changing energy expenditure substrate utilisation from glucose to lipid and activating brown adipose tissue in the presence of the changing hormones throughout the estrous cycle that alter temperature in healthy adult females
Secondary ID [1] 311126 0
none
Universal Trial Number (UTN)
U1111-1301-3038
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metabolic syndrome 332285 0
Condition category
Condition code
Metabolic and Endocrine 329000 329000 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm A
Intervention type: Dietary Supplement
Intervention name: Capsaicin
Intervention description: 475mg of Capsicum annum fruit powder containing 2.375mg of capsaicin in a capsule. One capsule will be given for consumption 45 minutes after a 90g glucose in the form of a gel has been ingested. The dose is the contents of one capsule from the manufacturer transferred to an unidentifiable capsule as per the placebo. The capsules are approved, health store/supermarket retail products manufactured in Australia by Nature’s Sunshine Products of Australia Pty. Ltd. The intervention will be given on four individual days each one week apart in the presence of the researher.
Intervention code [1] 327572 0
Treatment: Other
Comparator / control treatment
Arm B is the control/placebo
Intervention type: Dietary Supplement
Intervention name: Lactose
Intervention description: 100mg lactose in a capsule. one capsule will be given for oral consumption 45 minutes after 90g glucose in the form of a gel, has been ingested. Food grade lactose (Ajax Chemicals) will be weighed and transferred to the same type of capsule as the intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 336791 0
Brown adipose tissue thermogenesis
Timepoint [1] 336791 0
Change from baseline with measures at baseline, after glucose ingestion and at 15-minute intervals for a total of 90 minutes after ingestion of the supplement at each scheduled visit
Secondary outcome [1] 429674 0
respiratory exchange ratio
Timepoint [1] 429674 0
gaseous exchange measures at baseline, after glucose ingestion and at 15-minute intervals for a total of 90 minutes after ingestion of supplement at each scheduled visit.
Secondary outcome [2] 429675 0
Blood glucose level
Timepoint [2] 429675 0
measures at baseline, after glucose ingestion and at 15-minute intervals for a total of 90 minutes after ingestion of supplement at each scheduled visit.

Eligibility
Key inclusion criteria
1. Healthy with no medical conditions (no diagnosed medical conditions that require the person to take prescription medication)
To eliminate different hormone patterns or altered carbohydrate metabolism that has been seen in disease states (such as diabetes), which ultimately could affect the final results.
2. Must be available for morning testing (up to 5 hours) on four individual days one week apart to cover the average oestrous cycle
3. Willingness to fast overnight.
4. Adult females with healthy BMI (18.5 -24.9 kg/m2) BMI is used to estimate the amount of fat and gives a healthy weight range related to individual height.
To minimize any underlying metabolic disorders
5. Ability to tolerate oral ingestion of capsaicin determined by previous ingestion of capsicum containing foods/supplements.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Diagnosis of any medical conditions
Disease states such as diabetes can alter participants’ metabolism. This would affect the researcher’s ability to determine the full effect capsaicin has on lipid and carbohydrate metabolism
2. Must be able to understand and comprehend instructions given to them in English, as determined by the researcher.
There will not be translator available to assist participants during testing.
3. Taking any regular medications for a diagnosed medical condition
Metabolism (lipid and carbohydrate) can be affected by different medications and could interfere with obtaining accurate results.
4. Inability to tolerate or experience of adverse effects from capsaicin or capsaicin containing products
Participants who cannot tolerate or experience adverse effects from capsaicin are excluded from the experiment.
5. Participants who have never ingested capsaicin or capsaicin containing product will be excluded from the experiment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated to intervention groups, Arm A or Arm B. The interventions will be numbered with the participant number and the capsules added to a numerically labelled envelope. the sealed envelope will be given to the researchers when the participant is attending each of the laboratory sessions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be done by computer generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/03/2024
Actual
10/03/2024
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
16
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315383 0
University
Name [1] 315383 0
La Trobe University
Country [1] 315383 0
Australia
Primary sponsor type
University
Name
La Trobe university
Address
Edwards Rd Bendigo Vic 3550
Country
Australia
Secondary sponsor category [1] 317447 0
None
Name [1] 317447 0
Address [1] 317447 0
Country [1] 317447 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314300 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 314300 0
Ethics committee country [1] 314300 0
Australia
Date submitted for ethics approval [1] 314300 0
08/11/2023
Approval date [1] 314300 0
07/02/2024
Ethics approval number [1] 314300 0
HEC23418

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131114 0
Dr Christine Kettle
Address 131114 0
La Trobe University Edwards Rd Bendigo Vic 3550
Country 131114 0
Australia
Phone 131114 0
+61 354447959
Fax 131114 0
Email 131114 0
[email protected]
Contact person for public queries
Name 131115 0
Christine Kettle
Address 131115 0
La Trobe University Edwards Rd Bendigo Vic 3550
Country 131115 0
Australia
Phone 131115 0
+61 354447959
Fax 131115 0
Email 131115 0
[email protected]
Contact person for scientific queries
Name 131116 0
Christine Kettle
Address 131116 0
La Trobe University Edwards Rd Bendigo Vic 3550
Country 131116 0
Australia
Phone 131116 0
+61 354447959
Fax 131116 0
Email 131116 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.