A double-blind, randomised, placebo-controlled interventional study to evaluate the effect of orally-dosed herbal extract, Gynostemma pentaphyllum extract (ActivAMP) capsules on body composition in overweight men and women aged over 18 years.

The investigational product is a commercially available capsule-form herbal medicine containing Gynostemma pentaphyllum extract (ActivAMP). The daily dose will be 450mg across 2 capsules daily, 1 taken at breakfast and one at dinner for a period of 16 weeks. This regime has been selected on the basis of current standard dosing guidelines for the investigational product. This study will assess the effect of ActivAMP on body composition and muscle recovery in overweight males and females to better understand its effectiveness. Approximately 55 male and 55 female participants aged over 18 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, physical assessment 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=55) or the active intervention group (n=55 per group). Muscle fatigue, recovery, body composition, dietary intake and quality of life will be assessed at enrolment. Within the week pre-treatment, participant’s blood will be collected for analysis of pre-treatment blood markers. Specifically, total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol, free fatty acids, blood glucose, E/LFT, kidney function/safety, liver function/safety and inflammatory and antioxidant panel. 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 5 and 10 for body composition assessment. An investigator will call participants a few times throughout the 16 weeks study to ask some questions about their usual diet. At the completion of the study (week 16), an assessment identical to what was undertaken at baseline will be carried out. Participants will be asked to provide a physical activity and diet diary at the start of the study. Participants will then be asked to maintain their normal level of physical activity for the study duration. At the end of the study, participants will repeat the same diet diary. If participants change their normal level of physical activity or diet they will be asked to inform us as soon as practically possible. Changes in diet and/or exercise will be evaluated by and accredited exercise physiologist. Subsequent suitability for ongoing participation in the trial will be evaluated and any changes will be taken into consideration when evaluating any results of the trial. Participants will also be monitored for compliance with the protocol by email communications in addition to during each scheduled site visit. Interim reporting of project status and adverse drug reactions will be provided to the sponsor and HREC as requested.