Efficacy of Morosil® on weight loss in overweight but otherwise healthy men and women. A randomised double-blind placebo-controlled study.

INTERVENTION: The investigational product is a standardized extract obtained from the juice of Moro red oranges (Citrus sinensis). Citrus sinensis is a TGA approved therapeutic ingredient in complementary medicines. The trial product will be in capsule form, containing 400mg of Morosil extract to be taken twice per day with 200mL water at breakfast and dinner for 6 months. All participants will receive the same standard advice regarding physical activity. Specifically, participants will be asked to undertake 30 minutes of walking 3 times per week and record all physical activity in their diaries. In terms of dietary advice, participants will be asked to follow a kilojoule controlled diet. The amount of kilojoules to be consumed daily by each participant will be calculated using the basal metabolic rate score from their DEXA scan. Adherence will be monitored by trial product container return at the end of the study allowing for capsule count. CONDITION: Overweight PRIMARY OUTCOME: body weight measured via scales SECONDARY OUTCOME: android fat levels measured via DEXA scan Body mass index measured by DEXA scan Dietary energy intake via 24 hour food recall Fasting adiponectin measured via blood test fasting glucose measured via blood test Fasting grehelin measured by blood test fasting insulin measured via blood test fasting leptin measured via blood test fasting lipid profile via blood test fatigue severity as measured by VAS‐F Gastrointestinal tolerance measured by GIT questionnaire Gynoid fat levels measured via DEXA scan hip circumference measured via tape measure lean muscle mass measured via DEXA scan level of subcutaneous fat measured by DEXA scan level of visceral fat measured by DEXA scan Physical activity frequency via completing an online physical activity diary physical activity type via completing an online physical activity diary Safety markers E/LFT measured by blood test thigh circumference measured via tape measure total abdominal fat measured by DEXA scan waist circumference measured via tape measure INCLUSION CRITERIA: Males and females aged between 20 and 65 years BMI >25 ‐ <40 kg/m2 Not currently taking any medication, supplements or functional foods targeted at weight loss and/ appetite control Participants who agree to not use other treatment including diets for weight loss and/or appetite control during the study Participants agreement to participation in the study and investigational schedule Written informed consent from the participant