Effect of a 16-week Supplementation With a Mediterranean Fruit and Vegetables Extract Rich in Polyphenols, Fiit-ns®, on Health-related Quality of Life of Overweight and Obese Volunteers: a Randomized, Double-blind, Parallel Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Fytexia
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Change in health-related quality of life as assessed by the SF-36 Health Survey
研究概览
简要总结
The purpose of this study is to evaluate the effects of a 16-week supplementation with a polyphenol-rich extract, Fiit-ns®, on improvement of health-related quality of life (HR-QOL) of overweight and obese volunteers, as compared to placebo. Previous beneficial results from a pilot study showed that the supplementation may improve quality of life as well as body composition. Based on such results, this pivotal study is statistically powered to detect significant differences in HR-QOL assessed with the Short Form-36 Health survey (SF-36) between baseline (Week 1, W1) and end of the supplementation period (Week 16, W16).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25 kg/m2 ≤ Body Mass Index (BMI) ≤ 40 kg/m2
- •25-55 years old
排除标准
- •Metabolic and/or chronic disease (diabetes, dyslipidemia, thyroiditis, inflammatory disease, immunological disease, asthma, anxiety, depression)
- •Allergy to one of the ingredients of the supplement
- •Current involvement of involvement within the 6 previous months in a chronic supplement program, chronic treatment program, weight loss program
- •Smoking cessation
- •High alcohol consumption
- •Pregnancy
- •Breastfeeding
- •Menopausal women
- •Involvement in physical activity more than twice a week
研究组 & 干预措施
Verum
This arm receives 2 x 450 mg capsules of Fiit-ns®, a blend of polyphenol-rich fruit and vegetables extracts, daily for 16 weeks.
干预措施: Fiit-ns® (Dietary Supplement)
Placebo
This arm receives 2 x 450 mg capsules of Placebo, containing maltodextrin only, daily for 16 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in health-related quality of life as assessed by the SF-36 Health Survey
时间窗: Baseline (Week 1) and end of the supplementation period (Week 16)
次要结局
- Change in waist circumference(Baseline (Week 1) and end of the supplementation period (Week 16))
- Change in total body fat mass(Baseline (Week 1) and end of the supplementation period (Week 16))
- Change in body weight(Baseline (Week 1) and end of the supplementation period (Week 16))
- Change in physical activity level(Baseline (Week 1) and end of the supplementation period (Week 16))
- Change in trunk fat mass(Baseline (Week 1) and end of the supplementation period (Week 16 ))