Obesity, Overweight
Conditions
Brief summary
Subjects are randomized to either IQP-VV-102 or a matching placebo. Over 12 weeks, the subjects' body weight, body fat and safety parameters are monitored
Interventions
DIETARY_SUPPLEMENTIQP-VV-102
OTHERPlacebo
Sponsors
InQpharm Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18 to 60 years * 25 kg/m2 ≤ BMI ≤ 35 kg/m2 * Written informed consent
Exclusion criteria
* Known sensitivity to sources of the active ingredients and excipients * Pregnancy or nursing * Inability to comply with study requirements, e.g. due to language difficulties * Participation in another study during the last 30 days of the screening visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight at End of Study Compared to Baseline | 12 weeks | Change in body weight at the end of study compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Waist Circumference (in cm) at End of Study From Baseline | 12 weeks | Difference in waist circumference (in cm) at end of study from baseline |
| Change in Mean Body Fat at End of Study From Baseline | 12 weeks | Measured in kg using calibrated weighing scales |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IQP-VV-102 2 tablets twice a day
IQP-VV-102 | 57 |
| Placebo 2 tablets twice a day
Placebo | 60 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | IQP-VV-102 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 43.6 year STANDARD_DEVIATION 11.6 | 40.5 year STANDARD_DEVIATION 11.9 | 42.0 year STANDARD_DEVIATION 11.8 |
| Body Weight | 82.0 kg STANDARD_DEVIATION 10.6 | 84.9 kg STANDARD_DEVIATION 12.9 | 83.5 kg STANDARD_DEVIATION 11.9 |
| Sex: Female, Male Female | 45 Participants | 38 Participants | 83 Participants |
| Sex: Female, Male Male | 12 Participants | 22 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 57 | 8 / 60 |
| serious Total, serious adverse events | 0 / 57 | 0 / 60 |
Outcome results
Primary
Change in Body Weight at End of Study Compared to Baseline
Change in body weight at the end of study compared to baseline
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IQP-VV-102 | Change in Body Weight at End of Study Compared to Baseline | 3.29 kg | Standard Deviation 2.3 |
| Placebo | Change in Body Weight at End of Study Compared to Baseline | 0.83 kg | Standard Deviation 2 |
Secondary
Change in Mean Body Fat at End of Study From Baseline
Measured in kg using calibrated weighing scales
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IQP-VV-102 | Change in Mean Body Fat at End of Study From Baseline | 2.14 kg | Standard Deviation 3.42 |
| Placebo | Change in Mean Body Fat at End of Study From Baseline | 0.56 kg | Standard Deviation 2.43 |
Secondary
Change in Waist Circumference (in cm) at End of Study From Baseline
Difference in waist circumference (in cm) at end of study from baseline
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IQP-VV-102 | Change in Waist Circumference (in cm) at End of Study From Baseline | 2.11 cm | Standard Deviation 2.09 |
| Placebo | Change in Waist Circumference (in cm) at End of Study From Baseline | 0.81 cm | Standard Deviation 2.02 |