Obesity
Conditions
Brief summary
The purpose of this study is: * To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in treatment of obese patients. * To assess clinical efficacy of Dietressa in the dose of 6 tablets daily within 24 weeks of therapy in reducing body weight in obese patients. * To compare clinical efficacy of two dosage patterns for Dietressa (1 tablet 6 times daily and 2 tablets 3 times daily) within 24 weeks in treatment of obese patients.
Detailed description
In general, patients will be observed during 24 weeks of trial.
Interventions
DRUGDietressa
Comparison of different dosages (frequency) of drug
DRUGPlacebo
Placebo either (2 tablets 3 times daily) or (1 tablet 6 times daily)
Sponsors
Materia Medica Holding
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 65 Years
Healthy volunteers
No
Inclusion criteria
1. Outpatient subjects with BMI 30,0-34,9 kg/m2. 2. Male or female subjects aged 18 to 65 inclusive. 3. Use of and compliance with contraception methods by patients of reproductive age, of both sexes. 4. Presence of the patient's information sheet (informed consent form) for participation in the clinical trial.
Exclusion criteria
1. Symptomatic (secondary) obesity: * with established genetic defect (including as a part of known genetic syndromes affecting multiple organs): Prader-Willi syndrome, Alstrom's syndrome, Laurence-Moon-Biedl syndrome, Dercum's syndrome etc. * cerebral (adiposogenital dystrophy, Babinski-Frohlich syndrome): brain tumors; dissemination of systemic lesions, infectious diseases; against mental diseases. * endocrine: hypothyroid; hypoovarial; pituitary-hypothalamic disorders; adrenopathy. * iatrogenic (caused by drug administration, namely, insulin, glucocorticosteroids, neuroleptics etc.). 2. Compliance with a diet prescribed and monitored by the doctor to reduce body weight within 6 months before enrollment. 3. Participation in the lifestyle modification program within 6 months before enrollment. 4. Patients who quit smoking within 6 months before enrollment, or intending to quit smoking during the period of participation in the trial, as well as intending to begin smoking during the trial. 5. Uncontrolled arterial hypertension (patients with 1-3 degree AH, receiving no adequate antihypertensive therapy). 6. Type 1 and 2 diabetes mellitus. 7. Edema syndrome with various etiology (chronic cardiac failure, nephrotic syndrome, hepatic cirrhosis). 8. Circulatory failure, IIА degree and above. 9. Decompensated cardiovascular disease, liver, kidney or gastrointestinal tract disease, metabolic, respiratory, endocrine, hematologic disease, peripheral vessel disease or another medical state. Oncological disease. 10. Diseases and states, which, in the investigator's opinion, may prevent the patient from participating in the trial. 11. Past history of bulimia / non-drug abepithymia. 12. Past history of any bariatric surgeries. 13. Lipoplasty underwent less then 1 year prior to screening visit, or cavitary surgery less then 6 months prior to screening visit. 14. Surgeries scheduled within 6 months. 15. Allergy to/intolerance of any of the drug components used during treatment. 16. Malabsorption syndrome, including congenial or acquired lactase or another disaccharidase insufficiency. 17. Administration of drugs specified as Prohibited concomitant therapy, within 6 months before enrollment. 18. Pregnancy, breast-feeding, unwillingness to comply with contraception methods during the trial and within 30 days after completion of participation in the trial. 19. Drug and alcohol consumption (over 2 alc. units daily), mental diseases. Legal incapacity or limited legal capacity. 21\. Patients, who, in the investigator's opinion, will fail to observe the requirements during the trial or adhere to the studied drug administration procedure. 22\. Participation in other clinical trials within 3 months before enrolment in this trial. 23\. Presence of other factors, complicating the patient's participation in the trial (e.g., planned lengthy business and other trips). 24. A patient is a part of the center's research staff, taking a direct part in the trial, or an immediate family member of the investigator. Immediate family members are defined as spouses, parents, children or siblings, regardless of whether full blood or adopted. 25\. The patient is employed with Scientific Production Firm Materia Medica Holding LLC, i.e. is the company's employee, part-time employee under contract, or appointed official in charge of the trial, or their immediate family.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment | assessed after 24 weeks of treatment |
| Average Body Weight Change After 24 Weeks of Treatment | assessed after 24 weeks of treatment |
| Average Relative Change in Body Weight After 24 Weeks of Treatment | assessed after 24 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | assessed after 4, 8, 12, 16, 20, and 24 weeks of treatment | — |
| Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | baseline, 4, 12 and 24 weeks | 36 items of the questionnaire are grouped into eight subscales. The subscales are grouped in two scales: the physical component of health and mental health component. The scores of each scale range between 0 and 100: the higher the score, the better the quality of life and the better the patient's health. The instruction is not given completely because of the large volume. For more information, see: Ware J.E., Snow K.K., Kosinski M., Gandek B. SF-36 Health Survey. Manual and interpretation guide //The Health Institute, New England Medical Center. Boston, Mass.-1993. In this instruction is explained how eight subscales are combined to compute a total score. |
| Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | assessed after 4, 8, 12, 16, 20 and 24 weeks of treatment | — |
| Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | assessed after 4,12 and 24 weeks of treatment | — |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dietressa 1 Dietressa: 1 tablet 6 times daily | 208 |
| Dietressa 2 Dietressa: 2 tablets 3 times daily | 194 |
| Placebo 3 Placebo: 1 tablet 6 times daily | 49 |
| Placebo 4 Placebo: 2 tablets 3 times daily | 33 |
| Total | 484 |
Baseline characteristics
| Characteristic | Dietressa 1 | Dietressa 2 | Placebo 3 | Placebo 4 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 41.2 years STANDARD_DEVIATION 12.1 | 42.4 years STANDARD_DEVIATION 12.1 | 41.4 years STANDARD_DEVIATION 10.3 | 42.8 years STANDARD_DEVIATION 11.3 | 41.9 years STANDARD_DEVIATION 11.8 |
| BMI | 32.1 kilogram/m^2 STANDARD_DEVIATION 1.4 | 32.0 kilogram/m^2 STANDARD_DEVIATION 1.5 | 32.2 kilogram/m^2 STANDARD_DEVIATION 1.5 | 31.6 kilogram/m^2 STANDARD_DEVIATION 1.3 | 32.0 kilogram/m^2 STANDARD_DEVIATION 1.4 |
| Height | 166.4 centimeter STANDARD_DEVIATION 8.3 | 165.1 centimeter STANDARD_DEVIATION 7.9 | 164.4 centimeter STANDARD_DEVIATION 6.7 | 164.9 centimeter STANDARD_DEVIATION 7.8 | 165.6 centimeter STANDARD_DEVIATION 8 |
| Sex: Female, Male Female | 181 Participants | 167 Participants | 44 Participants | 30 Participants | 422 Participants |
| Sex: Female, Male Male | 27 Participants | 27 Participants | 5 Participants | 3 Participants | 62 Participants |
| Weight | 89.1 kilogram STANDARD_DEVIATION 10.6 | 87.5 kilogram STANDARD_DEVIATION 9.5 | 87.1 kilogram STANDARD_DEVIATION 7.7 | 86.1 kilogram STANDARD_DEVIATION 9.8 | 88.1 kilogram STANDARD_DEVIATION 9.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 160 / 410 | 33 / 83 |
| serious Total, serious adverse events | 3 / 410 | 0 / 83 |
Outcome results
Primary
Average Body Weight Change After 24 Weeks of Treatment
Time frame: assessed after 24 weeks of treatment
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietressa 1 | Average Body Weight Change After 24 Weeks of Treatment | -4.4 kilogram | Standard Deviation 4.2 |
| Dietressa 2 | Average Body Weight Change After 24 Weeks of Treatment | -4.4 kilogram | Standard Deviation 4.4 |
| Placebo 3 | Average Body Weight Change After 24 Weeks of Treatment | -3.0 kilogram | Standard Deviation 3.5 |
| Placebo 4 | Average Body Weight Change After 24 Weeks of Treatment | -2.9 kilogram | Standard Deviation 2.8 |
p-value: 0.03t-test, 2 sided
p-value: 0.07t-test, 2 sided
Primary
Average Relative Change in Body Weight After 24 Weeks of Treatment
Time frame: assessed after 24 weeks of treatment
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietressa 1 | Average Relative Change in Body Weight After 24 Weeks of Treatment | -4.9 percentage of body weight | Standard Deviation 4.7 |
| Dietressa 2 | Average Relative Change in Body Weight After 24 Weeks of Treatment | -4.9 percentage of body weight | Standard Deviation 4.9 |
| Placebo 3 | Average Relative Change in Body Weight After 24 Weeks of Treatment | -3.4 percentage of body weight | Standard Deviation 4.2 |
| Placebo 4 | Average Relative Change in Body Weight After 24 Weeks of Treatment | -3.4 percentage of body weight | Standard Deviation 3.3 |
p-value: 0.03t-test, 2 sided
p-value: 0.07t-test, 2 sided
Primary
Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment
Time frame: assessed after 24 weeks of treatment
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dietressa 1 | Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment | 49 percentage of participants |
| Dietressa 2 | Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment | 48 percentage of participants |
| Placebo 3 | Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment | 33 percentage of participants |
| Placebo 4 | Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment | 21 percentage of participants |
p-value: 0.04Chi-squared
p-value: 0.004Chi-squared
p-value: 0.0007Cochran-Mantel-Haenszel
Secondary
Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
Time frame: assessed after 4, 8, 12, 16, 20 and 24 weeks of treatment
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dietressa 1 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 4 weeks | -1.5 percentage of body weight | Standard Deviation 1.8 |
| Dietressa 1 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 8 weeks | -2.5 percentage of body weight | Standard Deviation 2.6 |
| Dietressa 1 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 12 weeks | -3.2 percentage of body weight | Standard Deviation 3.1 |
| Dietressa 1 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 16 weeks | -3.9 percentage of body weight | Standard Deviation 3.7 |
| Dietressa 1 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 20 weeks | -4.3 percentage of body weight | Standard Deviation 4.1 |
| Dietressa 1 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 24 weeks | -4.9 percentage of body weight | Standard Deviation 4.7 |
| Dietressa 2 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 24 weeks | -4.9 percentage of body weight | Standard Deviation 4.9 |
| Dietressa 2 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 16 weeks | -4.0 percentage of body weight | Standard Deviation 3.9 |
| Dietressa 2 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 4 weeks | -1.4 percentage of body weight | Standard Deviation 2.1 |
| Dietressa 2 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 12 weeks | -3.3 percentage of body weight | Standard Deviation 3.4 |
| Dietressa 2 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 8 weeks | -2.5 percentage of body weight | Standard Deviation 2.7 |
| Dietressa 2 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 20 weeks | -4.5 percentage of body weight | Standard Deviation 4.4 |
| Placebo 3 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 8 weeks | -1.3 percentage of body weight | Standard Deviation 3.8 |
| Placebo 3 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 12 weeks | -2.1 percentage of body weight | Standard Deviation 3.2 |
| Placebo 3 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 16 weeks | -2.8 percentage of body weight | Standard Deviation 3.7 |
| Placebo 3 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 24 weeks | -3.4 percentage of body weight | Standard Deviation 4.2 |
| Placebo 3 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 20 weeks | -3.1 percentage of body weight | Standard Deviation 4 |
| Placebo 3 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 4 weeks | -0.8 percentage of body weight | Standard Deviation 2.1 |
| Placebo 4 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 20 weeks | -2.8 percentage of body weight | Standard Deviation 3.1 |
| Placebo 4 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 24 weeks | -3.4 percentage of body weight | Standard Deviation 3.3 |
| Placebo 4 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 8 weeks | -1.5 percentage of body weight | Standard Deviation 1.9 |
| Placebo 4 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 16 weeks | -2.6 percentage of body weight | Standard Deviation 2.8 |
| Placebo 4 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 4 weeks | -0.8 percentage of body weight | Standard Deviation 1.4 |
| Placebo 4 | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 12 weeks | -2.2 percentage of body weight | Standard Deviation 2.7 |
p-value: 0.019ANCOVA
p-value: 0.043ANCOVA
Secondary
Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment
36 items of the questionnaire are grouped into eight subscales. The subscales are grouped in two scales: the physical component of health and mental health component. The scores of each scale range between 0 and 100: the higher the score, the better the quality of life and the better the patient's health. The instruction is not given completely because of the large volume. For more information, see: Ware J.E., Snow K.K., Kosinski M., Gandek B. SF-36 Health Survey. Manual and interpretation guide //The Health Institute, New England Medical Center. Boston, Mass.-1993. In this instruction is explained how eight subscales are combined to compute a total score.
Time frame: baseline, 4, 12 and 24 weeks
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dietressa 1 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 12 weeks (physical) | 52.2 scores on a scale | Standard Deviation 6.4 |
| Dietressa 1 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 24 weeks (physical) | 52.4 scores on a scale | Standard Deviation 6.5 |
| Dietressa 1 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 0 week (physical) | 50.0 scores on a scale | Standard Deviation 7.9 |
| Dietressa 1 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 0 week (mental) | 43.7 scores on a scale | Standard Deviation 9.5 |
| Dietressa 1 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 4 weeks (mental) | 46.4 scores on a scale | Standard Deviation 9.3 |
| Dietressa 1 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 12 weeks (mental) | 46.5 scores on a scale | Standard Deviation 9.3 |
| Dietressa 1 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 24 weeks (mental) | 48.3 scores on a scale | Standard Deviation 8.7 |
| Dietressa 1 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 4 weeks (physical) | 51.2 scores on a scale | Standard Deviation 7.1 |
| Dietressa 2 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 4 weeks (physical) | 50.1 scores on a scale | Standard Deviation 6.8 |
| Dietressa 2 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 0 week (mental) | 43.4 scores on a scale | Standard Deviation 10.4 |
| Dietressa 2 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 0 week (physical) | 49.5 scores on a scale | Standard Deviation 7.3 |
| Dietressa 2 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 4 weeks (mental) | 46.1 scores on a scale | Standard Deviation 9.8 |
| Dietressa 2 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 24 weeks (mental) | 47.5 scores on a scale | Standard Deviation 9.2 |
| Dietressa 2 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 12 weeks (physical) | 50.8 scores on a scale | Standard Deviation 7.2 |
| Dietressa 2 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 12 weeks (mental) | 46.6 scores on a scale | Standard Deviation 10.2 |
| Dietressa 2 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 24 weeks (physical) | 51.3 scores on a scale | Standard Deviation 6.9 |
| Placebo 3 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 24 weeks (physical) | 51.7 scores on a scale | Standard Deviation 6.2 |
| Placebo 3 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 12 weeks (mental) | 49.3 scores on a scale | Standard Deviation 6.3 |
| Placebo 3 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 0 week (mental) | 44.3 scores on a scale | Standard Deviation 9.5 |
| Placebo 3 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 12 weeks (physical) | 51.3 scores on a scale | Standard Deviation 5.9 |
| Placebo 3 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 4 weeks (physical) | 51.0 scores on a scale | Standard Deviation 6.8 |
| Placebo 3 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 24 weeks (mental) | 50.6 scores on a scale | Standard Deviation 7 |
| Placebo 3 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 4 weeks (mental) | 49.0 scores on a scale | Standard Deviation 9.1 |
| Placebo 3 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 0 week (physical) | 49.5 scores on a scale | Standard Deviation 7.3 |
| Placebo 4 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 24 weeks (physical) | 52.3 scores on a scale | Standard Deviation 6.2 |
| Placebo 4 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 0 week (physical) | 50.7 scores on a scale | Standard Deviation 7.6 |
| Placebo 4 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 0 week (mental) | 47.5 scores on a scale | Standard Deviation 7.3 |
| Placebo 4 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 4 weeks (mental) | 49.5 scores on a scale | Standard Deviation 8 |
| Placebo 4 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 12 weeks (mental) | 49.0 scores on a scale | Standard Deviation 8.6 |
| Placebo 4 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 4 weeks (physical) | 51.5 scores on a scale | Standard Deviation 6.9 |
| Placebo 4 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 12 weeks (physical) | 50.7 scores on a scale | Standard Deviation 7.8 |
| Placebo 4 | Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 24 weeks (mental) | 50.0 scores on a scale | Standard Deviation 8.6 |
Comparison: SF-36 Mental Health Domainp-value: 0.02ANCOVA
Comparison: SF-36 Mental Health Domainp-value: 0.63ANCOVA
Comparison: SF-36 Physical Health Domainp-value: 0.6ANCOVA
Comparison: SF-36 Physical Health Domainp-value: 0.98ANCOVA
Secondary
Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
Time frame: assessed after 4, 8, 12, 16, 20, and 24 weeks of treatment
Population: Intention to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dietressa 1 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 4 weeks | 4 percentage of participants |
| Dietressa 1 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 8 weeks | 17 percentage of participants |
| Dietressa 1 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 12 weeks | 26 percentage of participants |
| Dietressa 1 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 16 weeks | 34 percentage of participants |
| Dietressa 1 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 20 weeks | 38 percentage of participants |
| Dietressa 1 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 24 weeks | 49 percentage of participants |
| Dietressa 2 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 24 weeks | 48 percentage of participants |
| Dietressa 2 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 16 weeks | 36 percentage of participants |
| Dietressa 2 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 4 weeks | 5 percentage of participants |
| Dietressa 2 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 12 weeks | 24 percentage of participants |
| Dietressa 2 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 8 weeks | 16 percentage of participants |
| Dietressa 2 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 20 weeks | 42 percentage of participants |
| Placebo 3 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 8 weeks | 8 percentage of participants |
| Placebo 3 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 12 weeks | 12 percentage of participants |
| Placebo 3 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 16 weeks | 16 percentage of participants |
| Placebo 3 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 24 weeks | 33 percentage of participants |
| Placebo 3 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 20 weeks | 22 percentage of participants |
| Placebo 3 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 4 weeks | 4 percentage of participants |
| Placebo 4 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 20 weeks | 15 percentage of participants |
| Placebo 4 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 24 weeks | 21 percentage of participants |
| Placebo 4 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 8 weeks | 3 percentage of participants |
| Placebo 4 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 16 weeks | 18 percentage of participants |
| Placebo 4 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 4 weeks | 0 percentage of participants |
| Placebo 4 | Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | 12 weeks | 15 percentage of participants |
p-value: <0.05Chi-squared
p-value: <0.05Chi-squared
Secondary
Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment
Time frame: assessed after 4,12 and 24 weeks of treatment
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dietressa 1 | Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | 0 week | 0.88 waist hip ratio | Standard Deviation 0.08 |
| Dietressa 1 | Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | 12 weeks | 0.88 waist hip ratio | Standard Deviation 0.08 |
| Dietressa 1 | Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | 4 weeks | 0.88 waist hip ratio | Standard Deviation 0.08 |
| Dietressa 1 | Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | 24 weeks | 0.87 waist hip ratio | Standard Deviation 0.08 |
| Dietressa 2 | Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | 4 weeks | 0.89 waist hip ratio | Standard Deviation 0.09 |
| Dietressa 2 | Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | 0 week | 0.89 waist hip ratio | Standard Deviation 0.09 |
| Dietressa 2 | Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | 24 weeks | 0.88 waist hip ratio | Standard Deviation 0.09 |
| Dietressa 2 | Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | 12 weeks | 0.88 waist hip ratio | Standard Deviation 0.09 |
| Placebo 3 | Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | 4 weeks | 0.88 waist hip ratio | Standard Deviation 0.08 |
| Placebo 3 | Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | 0 week | 0.89 waist hip ratio | Standard Deviation 0.07 |
| Placebo 3 | Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | 12 weeks | 0.87 waist hip ratio | Standard Deviation 0.08 |
| Placebo 3 | Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | 24 weeks | 0.87 waist hip ratio | Standard Deviation 0.08 |
| Placebo 4 | Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | 24 weeks | 0.85 waist hip ratio | Standard Deviation 0.08 |
| Placebo 4 | Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | 12 weeks | 0.85 waist hip ratio | Standard Deviation 0.08 |
| Placebo 4 | Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | 4 weeks | 0.85 waist hip ratio | Standard Deviation 0.08 |
| Placebo 4 | Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | 0 week | 0.86 waist hip ratio | Standard Deviation 0.08 |
p-value: 0.2ANCOVA
p-value: 0.75ANCOVA