NCT03657186已完成不适用
Double-blind, Randomised, Placebo-controlled Study to Evaluate Benefit of ProbioSatys™ on Weight Reduction in Overweight Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- TargEDys
- 入组人数
- 236
- 试验地点
- 6
- 主要终点
- Proportion of subjects who lost at least 3% of baseline body weight (="3% responders")
研究概览
简要总结
The study aims to evaluate the effects of ProbioSatys™ on body weight and related parameters in overweight subjects during a 12-week consumption period. In addition, tolerability and safety of ProbioSatys™ will be assessed.
详细描述
ProbioSatys™ is a probiotic nutritional solution containing a commensal Enterobacteriaceae food grade strain, Hafnia alvei 4597. The microbiome is known to play a crucial role in body weight management and metabolic disease. ProbioSatys™ mechanism of action relies on bacterial metabolites that send local and central signals via the gut-brain axis by molecularly mimicking satiety hormones involved in appetite regulation.
Numerous ProbioSatys™pre-clinical studies indicate that consumption of the strain leads to body weight loss based on food intake reduction, but also improvement of body composition (increase of lean mass/fat mass ratio), and improvement of glucose metabolism (oral glucose tolerance test, and fasted glycemia).
The present study aims to evaluate the effects of ProbioSatys™ on body weight and related parameters in overweight subjects during a 12-week consumption period. In addition, tolerability and safety of ProbioSatys™ will be assessed.
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
- 否
入选标准
- •18 to 65 years old males and females
- •Overweight (Body Mass Index, BMI: 25 kg/m2 - 29.9 kg/m2)
- •Generally in good health
- •Desire to lose weight
- •Regularly consuming 3 main meals/day (breakfast, lunch, dinner)
- •Readiness to comply with study procedures, in particular:
- •Follow diet recommendation
- •Maintain the habitual level of physical activity during the study
- •Fill out the questionnaires and subject diary
- •Take the IP as instructed
- •Stable body weight in the last 3 months prior to V1 (≤5% self-reported change)
- •Stable concomitant medications (if any) for at least last 3 months prior to V1
- •Women of childbearing potential:
- •Negative pregnancy testing (beta HCG-test in urine) at V1
- •Women of childbearing potential: commitment to use contraception methods (with the exception of starting new contraception medication)
- •Participation is based upon written informed consent form by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.
- •Randomisation criteria (to be checked after run-in at V2):
- •No change in body weight or reduction up to 3 kg (compared to V1)
- •Adequately completed subject diary
- •Readiness and ability to comply with study requirements
- •Relevant inclusion and
排除标准
- •Exclusion Criteria:
- •Known allergy/sensitivity to any components of the investigational product
- •Pathological electrocardiogram (ECG) at V1
- •History and/or presence of clinically significant self-reported disorder as per investigator's judgement:
- •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)
- •Digestion/absorption disorders of the gastrointestinal tract (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.) and/ or gastrointestinal surgery
- •Diabetes mellitus type 1 or untreated/non-stabilised type 2
- •Acute or chronic psychotic disorder
- •Immunodeficiency
- •Any other organ or systemic diseases that could influence the conduct and/or outcome of the study and/or could affect the tolerability of the subject
- •History and/or presence of eating disorders like bulimia, anorexia nervosa, binge-eating as per investigator's judgement
- •Any electronic medical implant
- •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)
- •Use of medication/supplementation in the last month prior to V1 and during the study, as per investigator's judgement:
- •That could influence gastrointestinal functions (such as antibiotics, probiotics, laxatives, opioids, anticholinergics, anti-diarrheals etc.)
- •For weight management (e.g. fat binder/burner, satiety products etc.)
- •That could influence body weight (e.g. antidepressants, systemic corticoids etc.)
- •That could otherwise interfere with study conduct / evaluation
- •Diet/weight loss programs within the last 3 months prior to V1 and during the study
- •Smoking cessation/modification of smoking level (if any) within 6 months prior to V1 and/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
- •Pregnancy or nursing
- •History of or current abuse of drugs, alcohol or medication
- •Inability to comply with study procedures
- •Participation in another study during the last 30 days prior to V1
- •Any other reason deemed suitable for exclusion, per investigator's judgment
结局指标
主要结局
Proportion of subjects who lost at least 3% of baseline body weight (="3% responders")
时间窗: 12 weeks
次要结局
- Evaluation of the overall feeling of fullness compared to baseline by using visual analogue scales (VAS)(4, 8 and 12 weeks)
- Evaluation of the overall feeling of craving compared to baseline by using a 5 point Likert scale(4, 8 and 12 weeks)
- General well-being parameters (Impact of Weight on Quality of Life-Lite, IWQOL-LITE), compared to baseline(4, 8 and 12 weeks)
- Global evaluation of benefit at V5 by subject and the investigator(12 weeks)
- Body weight change (in kg), compared to baseline (V2)(4, 8 and 12 weeks)
- Body weight change (%), compared to baseline (V2)(4, 8 and 12 weeks)
- Body weight (in kg )(4, 8 and 12 weeks)
- Proportion of subjects who lost at least 3% of baseline body weight (="3% responders")(4 and 8 weeks)
- Proportion of subjects who lost at least 5% of baseline body weight (="5% responders")(4, 8 and 12 weeks)
- Body fat mass assessed per bioelectrical impedance analysis (BIA), compared to baseline(4, 8 and 12 weeks)
- Body fat free mass assessed per bioelectrical impedance analysis (BIA), compared to baseline(4, 8 and 12 weeks)
- Waist circumference, compared to baseline(4, 8 and 12 weeks)
- Hip circumference, compared to baseline(4, 8 and 12 weeks)
- Lipid metabolism parameters (total cholesterol), compared to screening values (V1)(14 weeks)
- Lipid metabolism parameters (high density lipid cholesterol), compared to screening values (V1)(14 weeks)
- Lipid metabolism parameters (low density lipid cholesterol), compared to screening values (V1)(14 weeks)
- Fasting glucose, compared to screening values (V1)(14 weeks)
- Glycated haemoglobin (HbA1c), compared to screening values (V1)(14 weeks)
- Evaluation of the overall feeling of satiety compared to baseline by using visual analogue scales (VAS)(4, 8 and 12 weeks)
研究者
研究点 (6)
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