Overweight
Conditions
Keywords
overweight, weight loss, body fat, waist circumference, satiety, appetite
Brief summary
The intention of the study is to evaluate the safety and potential body weight and body fat loss effects of a 12-week treatment with Zenoctil in a randomized, double-blind, placebo-controlled, parallel study conducted in Caucasian subjects. This study will also include a diet plan for each subject, calculated based on gender, age, and energy requirements; and adjusted to be slightly hypocaloric.
Interventions
DIETARY_SUPPLEMENTZenoctil
3 tablets 2 times daily
OTHERPlacebo
3 tablets 2 times daily
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
* Caucasian males and females, age 18 to 60 years * 25 kg/m2 ≤ BMI ≤32 kg/m2 * Expressed desire for weight loss * Accustomed to 3 main meals a day * Consistent and stable body weight 3 months prior to study enrollment * Commitment to avoid the use of other weight loss products/programs during the study * Commitment to adhere to diet recommendation * Females' agreement to use appropriate birth control methods during the active study period * Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply
Exclusion criteria
* Known sensitivity to Garcinia cambogia, Lagerstroemia speciosa (other members of Lythraceae family), caffeine, tannins * History of diabetes mellitus or other endocrine disorders * Fasting blood glucose \>7 mmol/L * Treatment with systemic corticosteroids within the last 12 months * Current use of antidepressants * Uncontrolled hypertension (\>160/110) or other uncontrolled cardiac, pulmonary, renal, or liver disease, determined to be clinically significant by the investigator * Presence of acute or history of chronic gastrointestinal disease * Schizophrenia or other diagnosed psychiatric disorders * Any other acute or chronic disease or any other medical condition which, in the investigator's view, may preclude subject's inclusion (e.g., cancer, HIV) * Bariatric surgery * Abdominal surgery within the last 6 months * History of eating disorders like bulimia, anorexia nervosa * Changes in the dose of estrogen, contraceptives or thyroid hormone within the last 3 months * Pregnancy or nursing * Any medication or use of products for the treatment of obesity (e.g., fat binder, carbohydrate blocker/starch blocker, fat burner, satiety products etc.) within the last 6 weeks * More than 3 hours strenuous sport activity per week * History of abuse of drugs, alcohol or medication * Smoking cessation within the 6 months prior to this study * Incompliance due to language difficulties * Participation in another study during the last 4 weeks * Clinically relevant excursions of safety parameters
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Body Weight (kg) | 12 weeks | Change in mean body weight at week 12 compared to baseline. |
| Change in Mean Body Fat (kg) | 12 weeks | Change in mean body fat at week 12 compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Hip Circumference | 12 weeks | — |
| Changes in Waist-hip-ratio | 12 weeks | — |
| Changes in Body Fat Content (%) | 12 weeks | — |
| Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ) | 12 weeks | — |
| Number of Subjects Who Lost at Least 3% of Baseline Body Weight | 12 weeks | — |
| Changes in Body Fat Free Mass (kg) | 12 weeks | — |
| Global Evaluation of Safety by Investigators | 12 weeks | The investigators evaluate independently the safety of the investigational product, using a scale with scores of very good, good, moderate and poor. |
| Global Evaluation of Safety by Subjects | 12 weeks | The subjects evaluate independently the safety of the investigational product, using a scale with scores of very good, good, moderate and poor. |
| Global Evaluation of Efficacy by Subjects | 12 weeks | The subjects evaluate independently the efficacy of the investigational product, using a scale with scores of very good, good, moderate and poor. |
| Subjects' Global Feeling of Satiety | 12 weeks | Subject's feeling of satiety (subsequent to the three main meals) is judged globally by the subjects on the basis of a 4 point rating scale: 0 = no; 1 = slightly, 2 = moderate and 3 = strong. |
| Changes in Waist Circumference (cm) | 12 weeks | — |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zenoctil Zenoctil: 3 tablets 2 times daily | 46 |
| Placebo Placebo: 3 tablets 2 times daily | 45 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Zenoctil | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 43.1 years STANDARD_DEVIATION 10.9 | 42.5 years STANDARD_DEVIATION 11.6 | 42.8 years STANDARD_DEVIATION 11.2 |
| Sex: Female, Male Female | 34 Participants | 28 Participants | 62 Participants |
| Sex: Female, Male Male | 12 Participants | 17 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 45 |
| serious Total, serious adverse events | 0 / 46 | 0 / 45 |
Outcome results
Primary
Change in Mean Body Fat (kg)
Change in mean body fat at week 12 compared to baseline
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zenoctil | Change in Mean Body Fat (kg) | -1.12 kg | Standard Deviation 1.84 |
| Placebo | Change in Mean Body Fat (kg) | 0.37 kg | Standard Deviation 2.14 |
Primary
Change in Mean Body Weight (kg)
Change in mean body weight at week 12 compared to baseline.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zenoctil | Change in Mean Body Weight (kg) | -2.26 kg | Standard Deviation 2.37 |
| Placebo | Change in Mean Body Weight (kg) | -0.56 kg | Standard Deviation 2.45 |
Secondary
Changes in Body Fat Content (%)
Time frame: 12 weeks
Secondary
Changes in Body Fat Free Mass (kg)
Time frame: 12 weeks
Secondary
Changes in Hip Circumference
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zenoctil | Changes in Hip Circumference | -1.54 cm | Standard Deviation 1.76 |
| Placebo | Changes in Hip Circumference | 0.64 cm | Standard Deviation 1.91 |
Secondary
Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ)
Time frame: 12 weeks
Secondary
Changes in Waist Circumference (cm)
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zenoctil | Changes in Waist Circumference (cm) | -2.00 cm | Standard Deviation 2.44 |
| Placebo | Changes in Waist Circumference (cm) | -0.69 cm | Standard Deviation 2.24 |
Secondary
Changes in Waist-hip-ratio
Time frame: 12 weeks
Secondary
Global Evaluation of Efficacy by Subjects
The subjects evaluate independently the efficacy of the investigational product, using a scale with scores of very good, good, moderate and poor.
Time frame: 12 weeks
Secondary
Global Evaluation of Safety by Investigators
The investigators evaluate independently the safety of the investigational product, using a scale with scores of very good, good, moderate and poor.
Time frame: 12 weeks
Secondary
Global Evaluation of Safety by Subjects
The subjects evaluate independently the safety of the investigational product, using a scale with scores of very good, good, moderate and poor.
Time frame: 12 weeks
Secondary
Number of Subjects Who Lost at Least 3% of Baseline Body Weight
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zenoctil | Number of Subjects Who Lost at Least 3% of Baseline Body Weight | 24 participants |
| Placebo | Number of Subjects Who Lost at Least 3% of Baseline Body Weight | 8 participants |
Secondary
Subjects' Global Feeling of Satiety
Subject's feeling of satiety (subsequent to the three main meals) is judged globally by the subjects on the basis of a 4 point rating scale: 0 = no; 1 = slightly, 2 = moderate and 3 = strong.
Time frame: 12 weeks