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Trial registered on ANZCTR


Registration number
ACTRN12620000202965
Ethics application status
Approved
Date submitted
30/01/2020
Date registered
20/02/2020
Date last updated
20/02/2020
Date data sharing statement initially provided
20/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a topical botanical cream on subcutaneous fat loss in athletes
Scientific title
Effects of a topical botanical cream containing coleus forskholii, silybin, ecommia ulmoides leaf, paullinia cupana seed, caffeine and black pepper essential oil on subcutaneous fat thickness in male resistance trained athletes
Secondary ID [1] 300402 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
FAT LOSS 316033 0
Condition category
Condition code
Diet and Nutrition 314311 314311 0 0
Obesity
Metabolic and Endocrine 314312 314312 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed study is an 8-week double-blind, placebo-controlled, within-group investigation in 20 resistance-trained males between 18 and 54 years of age. The participant’s thigh’s will serve as their own control, with a placebo being applied to one thigh, and Subcut to the other thigh. Before assignment, the dominant leg will be recorded. We will also ensure participants are not partaking in sports involving asymmetric limb use (e.g. football). The assignment of Subcut or a placebo to each leg will be completed by a member of the Human Sciences research team, who is not involved in the data collection or data analysis of this study. All participants will receive two sets of lotions of equal quantity in small containers labelled with two codes representing placebo or Subcut, with the key not being revealed to any of the researchers involved with data collection or data analysis. The lotions will be similar in appearance and texture. The placebo lotion will be an inert moisturising cream, which does not impact subcutaneous fat loss, and has previously been used as a placebo in a study investigating the efficacy of another fat loss lotion. As a final measure to prevent participants from identifying the placebo or active lotion, participants will only be accepted into the trial if they have not used topical fat loss lotions in the past. Also, participants will be deceived in that they will be informed that the study is about comparing the efficacy of two different fat loss lotions. Measures of weight, height, lean body mass and fat mass (via DEXA), thigh circumference and thigh subcutaneous fat tissue via ultra-sound will be completed at week 0, and at the completion of week 8. The purpose of the DEXA scan is to detect any potential overall changes in lean body mass and fat mass during the intervention. In addition, a food diary will be completed before, during and at the end of each trial. During the 8-week intervention, all participants will be instructed to follow their habitual diet, and not to engage in any weight loss program. Participants will be told to continue their regular training regimen consistently during the 8-week intervention, with this monitored via a daily training journal. Participants will be instructed to apply 5g of each lotion to the assigned thigh once every morning and once every night after showering, with no application of any other lotions to either thighs. They will also be instructed to wash their hands between applying lotions to the appropriate thighs to avoid contamination. A member of the research team (JP), blinded to the treatment, will have weekly interactions with the participants to monitor lotion application and dietary compliance. The co-primary outcomes in this trial will be changes in thigh circumference and thigh subcutaneous fat thickness after 8 weeks of application with Subcut or placebo. Differences in primary outcomes between treatments will be considered significant where p < 0.05.
Intervention code [1] 316691 0
Treatment: Other
Comparator / control treatment
The participant’s thigh’s will serve as their own control, with a placebo being applied to one thigh, and Subcut to the other thigh. Before assignment, the dominant leg will be recorded. We will also ensure participants are not partaking in sports involving asymmetric limb use (e.g. football). The assignment of Subcut or a placebo to each leg will be completed by a member of the Human Sciences research team, who is not involved in the data collection or data analysis of this study. All participants will receive two sets of lotions of equal quantity in small containers labelled with two codes representing placebo or Subcut, with the key not being revealed to any of the researchers involved with data collection or data analysis. The lotions will be similar in appearance and texture. The placebo lotion will be an inert moisturising cream (Cetaphil, Galderma, Fort Worth, TX), which does not impact subcutaneous fat loss, and has previously been used as a placebo in a study investigating the efficacy of another fat loss lotion (Escalante et al., 2019).
Control group
Placebo

Outcomes
Primary outcome [1] 322696 0
Change in thigh circumference via tape measure
Timepoint [1] 322696 0
After 8 weeks of treatment
Primary outcome [2] 322697 0
Change in thigh subcutaneous fat thickness via ultrasound
Timepoint [2] 322697 0
After 8 weeks of treatment
Secondary outcome [1] 379770 0
Weight via calibrated scale
Timepoint [1] 379770 0
After 8 weeks of treatment
Secondary outcome [2] 379771 0
Fat mass via DEXA
Timepoint [2] 379771 0
After 8 weeks of treatment

Eligibility
Key inclusion criteria
Male athletes aged > 18 y who have participated in regular resistance exercise (>2x per week) for at least the previous six months will be recruited from local sporting facilities for this trial.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previously used topical fat loss creams of any kind
Participate in asymmetrical limb-dominant sports e.g. soccer

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)
The assignment of Subcut or a placebo to each leg will be completed by a member of the Human Sciences research team by computer generated randomisation, who is not involved in the data collection or data analysis of this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation of each limb to Subcut or placebo will be via simple randomisation
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
Other
Other design features
within-subject comparison of treatments with thighs of each participant assigned to intervention or comparator
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A previous study investigating the effect of a topical lotion on subcutaneous thigh fat loss (via ultrasound) after 4 weeks was significantly powered with n = 18 to detect a 2.1 mm difference in fat loss between treated and untreated thighs at p < 0.005 (Armanini et al., 2005). Thus, as we expect our study to produce an effect of similar magnitude, we intend to recruit 20 participants. The co-primary outcomes in this clinical trial will be changes in thigh circumference and thigh subcutaneous fat thickness after 8 weeks of application with Subcut or placebo. Differences in primary outcomes between treatments will be considered significant where p < 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/02/2020
Actual
Date of last participant enrolment
Anticipated
30/04/2020
Actual
Date of last data collection
Anticipated
1/07/2020
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 304826 0
Commercial sector/Industry
Name [1] 304826 0
Renaissance Periodisation
Country [1] 304826 0
United States of America
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Hwy, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 305157 0
None
Name [1] 305157 0
NONE
Address [1] 305157 0
Country [1] 305157 0
Other collaborator category [1] 281151 0
Individual
Name [1] 281151 0
Professor Paul Fournier
Address [1] 281151 0
University of WA
35 Stirling Hwy, Crawley WA 6009
Country [1] 281151 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305237 0
UWA Human Research Ethics Committee
Ethics committee address [1] 305237 0
Ethics committee country [1] 305237 0
Australia
Date submitted for ethics approval [1] 305237 0
07/10/2019
Approval date [1] 305237 0
06/01/2020
Ethics approval number [1] 305237 0
RA/4/20/5772

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

Contacts
Principal investigator
Name 99718 0
Prof Paul Fournier
Address 99718 0
University of WA
35 Stirling Hwy, Crawley WA 6009
Country 99718 0
Australia
Phone 99718 0
+61 8 6488 6000
Fax 99718 0
Email 99718 0
PAUL.FOURNIER@UWA.EDU.AU
Contact person for public queries
Name 99719 0
Jackson Peos
Address 99719 0
University of WA
35 Stirling Hwy, Crawley WA 6009
Country 99719 0
Australia
Phone 99719 0
+61 421712283
Fax 99719 0
Email 99719 0
jackson.peos@research.uwa.edu.au
Contact person for scientific queries
Name 99720 0
Jackson Peos
Address 99720 0
University of WA
35 Stirling Hwy, Crawley WA 6009
Country 99720 0
Australia
Phone 99720 0
+61 421712283
Fax 99720 0
Email 99720 0
jackson.peos@research.uwa.edu.au

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.