A double-blind, randomised, placebo-controlled interventional study to evaluate the effect of orally-dosed herbal extract, Gynostemma pentaphyllum extract (ActivAMP) capsules on body composition in overweight men and women aged over 18 years.
- Conditions
- Overweight/obesityAlternative and Complementary Medicine - Herbal remediesDiet and Nutrition - Obesity
- Registration Number
- ACTRN12617000839303
- Lead Sponsor
- RDC Global Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 177
Males and females over 18 years of age
Overweight but not clinically obese (BMI >25 - <30 kg/m2)
Not currently taking any supplement or functional foods targeted at weight loss, muscle growth or exercise performance
Participants who agree to not use other treatment including diets for weight loss, muscle growth or exercise performance during the study
Participants agreement to participation in the study and investigation schedule
Written informed consent from the participant
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
Females with a clinical diagnosis of Polycystic ovarian syndrome (PCOS)
Prescription medication use other than females on the oral contractive pill
Significant variation in weight (more than 10%) in the past 3 months
Participation in another clinical trial in the past 3 months
Females attempting conception, currently pregnant or breast feeding
Allergies or hypersensitivity of any of the test ingredients
Alcohol consumption above 2 standard drinks daily, drug use, or other confounding conditions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method