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.
- Conditions
- Overweight/obesityappetite controlDiet and Nutrition - Obesity
- Registration Number
- ACTRN12617000872336
- Lead Sponsor
- RDC Global Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 140
Males and females aged between 20 and 50 years
Over weight but not clinically obese (BMI >25 - <30 kg/m2)
Not currently taking any supplement or functional foods targeted at appetite control and/or weight loss
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
Over weight but not clinically obese (BMI >25 - <30 kg/m2) - Changed to (BMI >25 - <34.9 kg/m2)
Females currently using an appropriate form of birth control.
Clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, gastrointestinal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled
Significant variation in weight (more than 10%) in the past 3 months
Participation in another clinical trial in the past 3 months
Current use of prescription medications except the oral contraceptive pill if female
Females attempting conception, currently pregnant or breastfeeding
Alcohol consumption of above 2 standards drinks daily, drug use, or other confounding conditions
Malignancy or treatment for malignancy within the previous 2 years
Pregnant or lactating women
Elite or training Athletes
Smokers
Shift workers/unusual sleep and/or dietary patterns
Excessive caffeine intake (>4 caffeinated drinks daily)
Those currently taking fibre supplements of 30-50g daily
Allergic to any of the ingredients in active or placebo formula
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Appetite Control measured by plasma ghrelin<br>[Baseline and week 16 only];Appetite Control Measured by plasma leptin[Baseline and week 16 only]
- Secondary Outcome Measures
Name Time Method