NCT03888911已完成不适用
Double-blind, Randomized, Three-armed, Placebo-controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-LU-104 in Reducing Body Weight in Overweight and Moderately Obese Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Mean change in body weight (kg)
研究概览
简要总结
This study is to evaluate the benefit and tolerability of two dosages of IQP-LU-104 (5120mg and 2560mg daily) in reducing body weight in overweight and moderately obese subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 65 years
- •Overweight (BMI 25 to < 30 kg/m2) and moderately obese (BMI 30 to < 35 kg/m2) subjects
- •Generally in good health
- •Desire to lose weight
- •Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner)
- •Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self-reported change)
- •Subject's agreement to comply with study procedures, in particular:
- •to take IP as recommended
- •to follow diet recommendation during the study
- •to complete the subject diary and study questionnaires
- •to maintain the habitual level of physical activity during the study
- •Women of childbearing potential:
- •commitment to use contraception methods
- •negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
- •Consents to participate, understands requirements of the study and is willing to comply
排除标准
- •Known sensitivity to the ingredients of the investigational product or source of ingredients
- •History and/or presence of clinically significant condition/disorder, which per investigator's judgment could interfere with the results of the study or the safety of the subject, e.g.:
- •untreated or non-stabilised thyroid gland disorder
- •untreated or non-stabilised hypertension (regular systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg)
- •acute or chronic gastrointestinal (GI) disease or digestion/absorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.)
- •diabetes mellitus type 1
- •untreated or non-stabilised diabetes mellitus type 2
- •any other relevant serious organ or systemic diseases
- •Significant surgery within the last 6 months prior to V1:
- •GI surgery
- •liposuction
- •History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 months prior to V1
- •Deviation of safety laboratory parameter(s) at V1 that is:
- •clinically significant or
- •> 2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome)
- •Any electronic medical implant
- •Regular medication and/or supplementation and/or treatment within the last month prior to V1 and during the study, which per investigator's judgment could interfere with the results of the study or the safety of the subject, e.g.:
- •that could influence body weight (e.g. systemic cortcosteroids, antipsychotics, anti-depressants)
- •that could influence gastrointestinal functions (e.g. antibiotics, laxatives, opioids, anticholinergics etc.) as per investigator judgment
- •for weight management (e.g. fat binder, carbohydrate/starch blocker, fat burner, satiety products etc.)
- •any other relevant medication and/or supplementation
- •Diet/weight loss programs within the last 3 months prior to V1 and during the study
- •Smoking cessation within 6 months prior to V1 or during the study (regular smoking during the study at the same level as prior to the study is allowed)
- •Vegetarian, vegan or other restrictive diet
- •Women of child-bearing potential: pregnancy or nursing
- •History of or current abuse of drugs, alcohol or medication
- •Participation in another clinical study in the 30 days prior to V1 and during the study
- •Any other reason for exclusion as per investigator's judgment
结局指标
主要结局
Mean change in body weight (kg)
时间窗: 12 weeks
Difference in mean change of body weight (kg) between the higher dosed verum and placebo group after 12 weeks of intervention in comparison to baseline
次要结局
- Body weight (kg)(4, 8, 12 weeks)
- Change in body weight percentage (%)(4, 8, 12 weeks)
- Proportion of subjects with weight loss(4, 8, 12 weeks)
- Mean change in body weight (kg)(4 and 8 weeks)
- Waist circumference (cm)(4, 8, 12 weeks)
- Change in waist circumference (cm)(4, 8, 12 weeks)
- Hip circumference (cm)(4, 8, 12 weeks)
- Change in hip circumference (cm)(4, 8, 12 weeks)
- Waist-hip ratio(4, 8, 12 weeks)
- Change in waist-hip ratio(4, 8, 12 weeks)
- BMI (kg/m^2)(4, 8, 12 weeks)
- Change in BMI (kg/m^2)(4, 8, 12 weeks)
- Body fat percentage (%)(4, 8, 12 weeks)
- Change in body fat percentage (%)(4, 8, 12 weeks)
- Body fat mass (kg)(4, 8, 12 weeks)
- Change in body fat mass (kg)(4, 8, 12 weeks)
- Change in fat free mass (kg)(4, 8, 12 weeks)
- Evaluation of feeling of craving using visual analogue scales (VAS)(4, 8, 12 weeks)
- Change in the evaluation of feeling of craving using visual analogue scales (VAS)(4, 8, 12 weeks)
- Change in the quality of life using Impact of Weight on Quality of Life (IWQOL-Lite) Questionnaire(4, 8, 12 weeks)
- Lipid metabolism parameters (mmol/l)(12 weeks)
- Fat free mass (kg)(4, 8, 12 weeks)
- Change in the evaluation of feeling of hunger using visual analogue scales (VAS)(4, 8, 12 weeks)
- Evaluation of feeling of satiety using visual analogue scales (VAS)(4, 8, 12 weeks)
- Change in the evaluation of feeling of satiety using visual analogue scales (VAS)(4, 8, 12 weeks)
- Evaluation of feeling of fullness using visual analogue scales (VAS)(4, 8, 12 weeks)
- Evaluation of feeling of hunger using visual analogue scales (VAS)(4, 8, 12 weeks)
- Change in the evaluation of feeling of fullness using visual analogue scales (VAS)(4, 8, 12 weeks)
- Change in lipid metabolism parameters (mmol/l)(12 weeks)
- HbA1C percentage (%)(12 weeks)
- Change in HbA1C percentage (%)(12 weeks)
研究者
研究点 (2)
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