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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
Barbara Grube
Berlin, Germany
Change in Mean Body Weight (kg)
Change in mean body weight at week 12 compared to baseline.
Time frame: 12 weeks
Change in Mean Body Fat (kg)
Change in mean body fat at week 12 compared to baseline
Time frame: 12 weeks
Number of Subjects Who Lost at Least 3% of Baseline Body Weight
Time frame: 12 weeks
Changes in Waist Circumference (cm)
Time frame: 12 weeks
Changes in Hip Circumference
Time frame: 12 weeks
Changes in Waist-hip-ratio
Time frame: 12 weeks
Changes in Body Fat Content (%)
Time frame: 12 weeks
Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ)
Time frame: 12 weeks
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
Changes in Body Fat Free Mass (kg)
Time frame: 12 weeks
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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
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
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