A double-blind placebo-controlled randomised clinical trial assessing the efficacy and safety of a novel herbal formulation for weight loss in an Australian population of healthy adults who are overweight.

INTERVENTION: The proprietary combined extracts called Slendacor/Slimvance from PLT health was prepared in the ratio of six parts Moringa oleifera (family Moringaceae) leaf, three parts Murraya koenigii (L.) Spreng. (family Rutaceae), and one‐part Curcuma longa L. (family Zingiberaceae) extract standardised to not less than 95% total curcuminoids. The extraction solvent for each includes: Curcuma longa: 100% ethanol extract and 100% ethyl acetate Moringa olefere: ethanol:water (90:10) Murraya keonigi: ethanol:water (60:40) The excipients include colloidal anhydrous silica, magnesium stearate and silicon dioxide in a gelatine capsule size “0”. The dosage is 1 capsules (450mg) twice a day 30 minutes before breakfast and dinner. This is to be taken for 16 weeks. Compliance will be measured by capsule return and counting at each follow‐up. The participants will be asked to bring back all empty containers as well as those with capsules remaining. These will also be checked against the participant diaries. CONDITION: Alternative and Complementary Medicine ‐ Herbal remedies Overweight; ; Overweight PRIMARY OUTCOME: To evaluate the effects of a novel herbal formulation for weight loss on percentage reduction in body weight from baseline to 16 weeks as assessed by percentage change in body weight as measure by a digital weight scale.[Baseline, 4, 8, 12, 16 weeks (Primary endpoint)] SECONDARY OUTCOME: To assess the safety of the novel herbal formulation via blood pathology testing for kidney function.[0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks. ] To assess the safety of the novel herbal formulation via blood pathology testing for liver function[0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks] To assess the safety of the novel herbal formulation via the reporting of adverse events via the CTCAE v 5 and participant self reported adverse events via a participant diary. [0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks] To determine the number of participants achieving a loss of at least 5% of initial body weight after 16 weeks as measure by a digital weight scale.[0 weeks, 4 weeks, 8 weeks, 16 weeks] To evaluate lipid profiles via blood pathology tests from baseline to 16 weeks[o weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks] To evaluate the amount of weight loss from baseline to 16 weeks between groups as assessed by changes in body weight via a digital weight scale. [0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks] To evaluate the changes in body mass index from baseline to 16 weeks as assessed via a digital weight scale and stadiometer to assess height. [0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks] To evaluate the changes in waist circumferences from baseline to 16 weeks using a measuring tape. [0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks] To evaluate the changes in waist to hip ratio from baseline to 16 weeks via measuring tape. [0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks] INCLUSION CRITERIA: 1. Adults aged between 18 and 60 years old 2. BMI 25‐29.9 kg/m2 3. Willingness to consume the prescribed study diet of approximately 1,500 KCal for women and 2000 KCal for men per day 4. Negative pregnancy test at baseline and 3 months for females of childbearing age, use of reliable contraception throughout the trial