Obese, Overweight, Weight Maintenance
Conditions
Keywords
Weight maintenance, Overweight, Obese, Weight management
Brief summary
The effect of Litramine on weight loss has previously been studied during a 12-week intervention period with promising results. The present study looks into the effect of weight maintenance using Litramine following initial weight loss, for a longer period of 24 weeks.
Interventions
DIETARY_SUPPLEMENTLitramine
Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)
DIETARY_SUPPLEMENTPlacebo
Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)
Sponsors
InQpharm Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Documented weight loss, achieved over the last 3 to 6 months either from participation in weight loss clinical trials or weight loss regimens, of at least 3% at the point of screening * BMI 25-35 before initial weight loss * Documented compliance (according to the investigator's judgement) to previous weight loss clinical trials/ regimens
Exclusion criteria
* Known sensitivity to the ingredients of the device (citric acid, acacia or Fabaceae family) * BMI \< 18.5 * Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Body Weight From Baseline to End of 24 Weeks | 24 weeks | Change in body weight at the end of 24 weeks measured in kg using a calibrated scale. (positive values signify weight gain, while negative values signify weight reduction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist and Hip Circumference (cm) | 24 weeks | Changes from baseline to end of study |
| Body Mass Index (kg/m^2) | 24 weeks | Changes from baseline to end of study |
| Full Blood Count | 24 weeks | Erythrocytes, leukocytes, thrombocytes, haematocrit, haemoglobin, Mean corpuscular volume (MCV), Mean corpuscular haemaglobin (MCH) |
| Blood Pressure | 24 weeks | Measured in mm Hg |
Countries
Germany
Participant flow
Recruitment details
Trial conducted from January 2012 to September 2012 in two study sites in Germany
Participants by arm
| Arm | Count |
|---|---|
| Placebo Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)
Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal) | 24 |
| Litramine Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)
Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal) | 25 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Litramine | Total |
|---|---|---|---|
| Age, Continuous | 44.1 years STANDARD_DEVIATION 11.2 | 44.7 years STANDARD_DEVIATION 11.4 | 44.4 years STANDARD_DEVIATION 11.2 |
| BMI (kg/m^2) | 27.7 kg/m^2 STANDARD_DEVIATION 2.4 | 27.3 kg/m^2 STANDARD_DEVIATION 2.1 | 27.5 kg/m^2 STANDARD_DEVIATION 2.2 |
| Body weight (kg) | 79.3 kg STANDARD_DEVIATION 9 | 78.2 kg STANDARD_DEVIATION 11.4 | 78.7 kg STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 18 Participants | 19 Participants | 37 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Mean Change in Body Weight From Baseline to End of 24 Weeks
Change in body weight at the end of 24 weeks measured in kg using a calibrated scale. (positive values signify weight gain, while negative values signify weight reduction
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change in Body Weight From Baseline to End of 24 Weeks | 1.62 kg | Standard Deviation 1.48 |
| Litramine | Mean Change in Body Weight From Baseline to End of 24 Weeks | -0.62 kg | Standard Deviation 1.55 |
Secondary
Blood Pressure
Measured in mm Hg
Time frame: 24 weeks
Secondary
Body Mass Index (kg/m^2)
Changes from baseline to end of study
Time frame: 24 weeks
Secondary
Full Blood Count
Erythrocytes, leukocytes, thrombocytes, haematocrit, haemoglobin, Mean corpuscular volume (MCV), Mean corpuscular haemaglobin (MCH)
Time frame: 24 weeks
Secondary
Waist and Hip Circumference (cm)
Changes from baseline to end of study
Time frame: 24 weeks