Clinical trial NCT03685656: Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers
Official title: Randomized, Double-blind, Placebo Controlled Trial of Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Overweight
Obesity
Slimming gel
Cosmetic product
Waist circumference
Thigh circumference
Lead sponsor: Nutravalia
Sponsor class: INDUSTRY
Collaborators: name: Slb Pharma
First posted: 2018-09-26
Enrollment: 208
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Waist circumference
timeFrame: 8 weeks
Secondary outcomes:
measure: Waist circumference
timeFrame: 2 weeks
measure: Abdominal circumference
timeFrame: 2 and 8 weeks
measure: Hip circumference
timeFrame: 2 and 8 weeks
measure: Thigh circumference
timeFrame: 2 and 8 weeks
measure: Abdominal skinfold using a Harpenden skinfold caliper
timeFrame: 2 and 8 weeks
measure: Cellulite
timeFrame: 2 and 8 weeks
measure: Elasticity and firmness of the abdominal skin
timeFrame: 2 and 8 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: GREDECO
Study officials:
References: