NCT03823196已完成不适用
Bioavailability, Pharmacokinetic and Mechanistic Study of Sinetrol® Xpur, a Polyphenol-rich Ingredient: an Open-label Study on Overweight Volunteers During a Chronical Supplementation and a Post-supplementation Follow-up
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Fytexia
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in plasma polyphenol metabolites concentration after acute and chronic ingestion of the ingredient
研究概览
简要总结
The purpose of the study is to investigate the metabolization and the bioavailability of bioactive compounds from Sinetrol® Xpur, a polyphenol-rich ingredient, during a 16-week long chronical supplementation. It will be investigated the mechanism of action in adipocyte cells to try to explain the beneficial effects of the ingredient on body composition, especially on both abdominal subcutaneous and visceral fat mass.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male and female with 30% min. and 70% max. of each sex, aged range: 20-50 years old
- •Overweight BMI range (27-30)
- •Having a total fat mass (BIA assessment) ≥ 25% for men and ≥ 32% for women
- •In good general health as evidenced by medical history
- •Ability to take oral medication and be willing to adhere to the regimen
- •Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
排除标准
- •Metabolic/Chronic disorders or any kind of disease
- •Current use of any medication or food supplement
- •Have in the past been in long-term antibiotherapy (1 month or more) and/or a regular antiobiotherapy in the past 12 months
- •Former obese with a history of yoyo-effect
- •Have been involved in a weight loss program in the past 12 months or subjected to a weight reduction surgery
- •Pregnancy or lactation, or women wanting to have a baby
- •Menopausal women
- •Known allergic reactions to components of the supplement, i.e., orange, grapefruit, guarana and/or caffeine
- •Having started or quit smoking
- •Having a high alcohol consumption
研究组 & 干预措施
Verum900
Experimental
The arm will receive 900 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks
干预措施: Verum900 (Dietary Supplement)
Verum1800
Experimental
The arm will receive 1800 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks
干预措施: Verum1800 (Dietary Supplement)
结局指标
主要结局
Change in plasma polyphenol metabolites concentration after acute and chronic ingestion of the ingredient
时间窗: Week 1 and Week 16
Change in urine polyphenol metabolites excretion after acute and chronic ingestion of the ingredient
时间窗: Week 1 and Week 16
次要结局
- Change in fecal microbiota composition(Week 1, Week 8, Week 16 and Week 20 (follow-up))
- Change in adipose tissue lipolysis assessed with free fatty acids concentration(Week 1 and Week 16)
- Change in adipose tissue secretion profile assessed by adiponectin concentration(Week 1 and Week 16)
- Change in total fat mass assessed by DXA(Week 1, Week 16 and Week 20 (follow-up))
- Change in abdominal visceral fat mass assessed by MRI(Week 1 and Week 16)
- Change in adipose tissue microbiota composition(Week 1 and Week 16)
- Change in adipose tissue lipolysis assessed with glycerol concentration(Week 1 and Week 16)
- Change in adipose tissue secretion profile assessed by leptin concentration(Week 1 and Week 16)
- Change in safety variables assessed by heart rate variation(Week 1 and Week 16)
- Change in blood microbiota composition(Week 1, Week 8, Week 16 and Week 20 (follow-up))
- Change in adipocytes diameters in adipose tissue(Week 1 and Week 16)
- Change in total fat-free mass assessed by DXA(Week 1, Week 16 and Week 20 (follow-up))
- Change in energy expenditure assessed by indirect calorimetry(Week 1, Week 16 and Week 20 (follow-up))
- Change in safety variables assessed by blood pressure variation (systole and diastole in mmHg)(Week 1 and Week 16)
- Change in abdominal fat mass assessed by MRI(Week 1 and Week 16)
- Change in abdominal subcutaneous fat mass assessed by MRI(Week 1 and Week 16)
研究者
研究点 (1)
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