Effects of a topical botanical cream on subcutaneous fat loss in athletes

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.