ACTRN12617000872336CompletedPhase 3
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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- RDC Global Pty Ltd
- Enrollment
- 140
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
- •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
Investigators
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