None listed
Conditions
Brief summary
This trial is based on findings from a studies conducted overseas which investigated the same product that will be used in this study to reduce weight. It was found to be very beneficial in these populations to reduce weight in people who are overweight, but we need to find out if it also assists people in Australia. Overweight is considered to be anyone who has a body mass index (BMI) between 25 to 29.9. This trial involves participation in a randomized controlled clinical trial which means being randomized to either a placebo or an active product group. There will be three trial sites, Lismore, Gold Coast or Brisbane. It will be conducted for 16 weeks (4 months) per person.
Interventions
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: ethano
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.
Sponsors
Southern Cross University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
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
Exclusion criteria
1. Obesity (BMI equal to or greater than 30) 2. Current use of other weight loss medications including stimulants, laxatives or diuretics taken solely for the purpose of weight loss in the last 3 months. 3. Recent unexplained weight loss or gain 4. History of eating disorders 5. History of thyroid, cardiovascular disease or diabetes 6. History of other clinically significant disorders (HIV, hepatitis, pancreatitis, lactic acidosis or hepatomegaly with steatosis) 7. History of motor weakness or peripheral sensory neuropathy 8. Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations 9. Diagnosis of alcoholism or recreational drug use 10. Severe mental illness or difficulty in communicating 11. History of allergy to spices and herbal products 12. Pregnant or breastfeeding females
Outcome results
None listed