NCT03853603已完成不适用
Clinical Study to Investigate the Effects of a Food Supplement With Santa Herba Extract on Weight Loss and Modulation of Appetite-related Biomarkers in Overweight Women - a Randomized, Placebo-controlled Parallel Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mibelle AG
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Body weight
研究概览
简要总结
Aim of the study is to investigate the effect of a 12-week supplementation of Santa Herba Extract on body weight in overweight and obese subjects. Additionally appetite related marker as well as marker of white adipose tissue browning will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is able and willing to follow the study protocol procedures to sign the Informed Consent Form prior to screening evaluations
- •Overweight and obese women with BMI 25 - 35 kg/m2 (limits included)
- •Age: 25 - 60 years
- •Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology
排除标准
- •Relevant history or presence of any medical disorder potentially interfering with this study (heavy depression, diabetes, active cancer, severe liver disease, heavy cardiovascular diseases (e.g. stroke, heart attack))
- •Chronic intake of medication/dietary supplements with impact on body weight or body composition or lipid modifying products (e.g. protein shakes, statins, omega-3 fatty acids, etc.) 2 months prior to screening or during the study; stable doses of e.g. hypertensive therapy and thyroid gland hormones are acceptable.
- •Change in hormonal contraceptive during or at least 3 months before the study
- •Consumption of any dietary supplement / fortified food (with exception of vitamin D and mineral supplements e.g. Ca, Mg)
- •Low body fat mass measured at screening with BIA ( bioelectrical impedance analysis ) (Cut off-value: <36% body fat).
- •Weight loss intervention or recent body weight change > 4.5 kg during last 3 months
- •Diet high in vegetables and fruits ≥ 5 portions per day
- •Vegan lifestyle
- •Smoker > 10 cigarettes / day
- •Gastrointestinal diseases/conditions (colitis ulcerosa, Crohn's disease, peptic ulcers, celiac disease)
研究组 & 干预措施
Placebo
Placebo Comparator
Maltodextrin
干预措施: Placebo (Dietary Supplement)
Santa herba extract
Active Comparator
Santa herba extract
干预措施: Santa herba (Dietary Supplement)
结局指标
主要结局
Body weight
时间窗: day 85
electronic scale
次要结局
- BCM/ECM index(Day 85)
- Concentration of lipid profile in serum(Day 85)
- Questionnaire about Appetite (AEBQ)(Day 85)
- Body fat (%)(Day 85)
- Waist-hip ratio (WHR)(Day 85)
- Sagittal abdominal diameter (SAD) [cm](Day 85)
- Concentration of Lipokin in plasma(Day 85)
研究者
研究点 (2)
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