A double-blind, randomised, placebo-controlled interventional study to evaluate the effect of orally-dosed herbal extract, Slimaluma capsules on appetite control and body composition in overweight men and women aged between 20 and 50 years.

This study will assess the effect of Slimaluma on body appetite control and body composition in healthy males and females to better understand its effectiveness. The investigational product is a commercially available capsule-form herbal medicine containing C. Fimbriata extract. The daily dose will be 1g across 2 capsules, 1 taken before breakfast and one before dinner for a period of 16 weeks. Approximately 120 overweight male and female participants aged between 20 and 50 years will be recruited from databases and public media outlets. Following preliminary screening via telephone, potential participants will attend the clinic for an information session and will be required to provide their consent for inclusion in the trial. Consenting participants will undergo a health assessment including lifestyle, current medications and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study. Once enrolled in the trial, participants will be randomly allocated to either the placebo comparator group (n=60) or the active intervention group (n=60 per group). Satiety, dietary intake, body composition and tolerance will be assessed at enrolment. Within the week pre-treatment, participant’s blood will be collected for analysis of pre-treatment blood markers. All participants will receive the same standard advice regarding diet and physical activity. Participants will be asked to take the allocated product according to the dose prescribed. In addition, participants will be asked to attend the study site at weeks 4, 8, 12 and 16 for a body composition, satiety, dietary intake and tolerance assessment. At the completion of the study (week 16), an assessment identical to what was undertaken at baseline will be carried out. Compliance will be monitored by capsule count upon return of trial product container at the end of the study. Everyone will be told to continue with their normal level of physical activity and to not change the diet if possible. If they do increase or decrease physical activity then an exercise physiologist will be consulted. And if they do change their diet then a dietitian will be consulted. Any changes will be self-monitored and self-reported. And any changes will be reported to RDC GLOBAL Pty Ltd but not affect study participation. And any changes will be considered once the study is completed.