Randomized, Double-blind, Placebo Controlled Trial of Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nutravalia
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Waist circumference
研究概览
简要总结
Overweight and obesity is defined, according to the World Health Organization (WHO), by abnormal or excessive accumulation of adipose or fatty tissue that may be harmful to health.
Overweight and obesity are therefore important determinants of health, which expose people to many pathologies whose consequences for individuals are not only health, but also social: stigma, prejudice, discrimination.
Indeed, most overweight people have a bad image of themselves. For some people, overweight can trigger stress, malaise and disgust.
To break free from this malaise and satisfy the growing desire of women to take care of their body, many products are present in the slimming beauty market.
EFFANACA3GEL is a prospective, randomized, double-blind, placebo controlled study. 208 healthy volunteers will be followed for 2 months during which they will use ANACA3 slimming gel. The aim of this study is to evaluate the effects of ANACA3 slimming gel on hip and waist circumferences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy woman,
- •Age between 18 and 65 years,
- •Body mass index (BMI) strictly greater than 23 kg / m² and strictly less than 35 kg / m² with a stable weight (± 2 kg) for at least 3 months,
- •Stable physical activity for at least 3 months,
- •Lack of firmness in the abdomen and thighs,
- •Presenting cellulite visible in the thighs, with a score of 3 to 8 according to the photographic scale used,
- •Hormonal treatment not modified for at least 3 months,
- •informed and written consent signed.
排除标准
- •Pregnant or lactating woman,
- •Use of a slimming product and / or anti-cellulite (oral or topical) in the month prior to participating in the study,
- •Slimming diet during the last 3 months,
- •Special diet: low calorie diet (slimming diet and / or medication taken with or without a significant increase in physical activity over the last 3 months) or special diet (vegetarians, vegans, any intake of nutritional supplements )
- •Smoking (more than 3 cigarettes per day) and/ or addiction to alcohol,
- •Consuming more than 3 cups of coffee and / or tea per day,
- •Active evolutionary pathology or a history of cancer,
- •Under corticosteroids or any other medicinal treatment that may have an influence on water retention without therapeutic balance at the time of inclusion,
- •Antecedent of surgery for bariatric and / or aesthetic,
- •Severe eating disorders (anorexia, bulimia, binge eating, etc.),
- •Not affiliated to a Social Security scheme.
研究组 & 干预措施
ANACA3
ANACA3 slimming gel
干预措施: Slimming gel (Other)
Placebo
Slimming gel contening no active ingredient
干预措施: Slimming gel placebo (Other)
结局指标
主要结局
Waist circumference
时间窗: 8 weeks
Measure of the waist circumference using a measuring tape.
次要结局
- Thigh circumference(2 and 8 weeks)
- Elasticity and firmness of the abdominal skin(2 and 8 weeks)
- Waist circumference(2 weeks)
- Abdominal circumference(2 and 8 weeks)
- Abdominal skinfold using a Harpenden skinfold caliper(2 and 8 weeks)
- Hip circumference(2 and 8 weeks)
- Cellulite(2 and 8 weeks)