Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Other: Slimming gel; Other: Slimming gel placebo

• Registration Number: NCT03685656
• Lead Sponsor: Nutravalia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-16
• Study Start: 2018-09-03
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-26
• Status Verified: 2019-02
• Primary Completion: 2019-02-13
• Study Completion: 2019-02-13
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 208

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ANACA3	Slimming gel	ANACA3 slimming gel
Placebo	Slimming gel placebo	Slimming gel contening no active ingredient

Primary Outcome Measures

Name	Time	Method
Waist circumference	8 weeks	Measure of the waist circumference using a measuring tape.

Secondary Outcome Measures

Name	Time	Method
Elasticity and firmness of the abdominal skin	2 and 8 weeks	Measure of the elasticity and firmness of the abdominal skin using a cutometer
Waist circumference	2 weeks	Measure of the waist circumference using a measuring tape.
Thigh circumference	2 and 8 weeks	Measure of thigh circumference using a measuring tape.
Abdominal circumference	2 and 8 weeks	Measure of the abdominal circumference (at the level of the navel) using a measuring tape.
Abdominal skinfold using a Harpenden skinfold caliper	2 and 8 weeks	Measure of the abdominal skinfold using a Harpenden skinfold caliper
Hip circumference	2 and 8 weeks	Measure of the hip circumference using a measuring tape.
Cellulite	2 and 8 weeks	Scoring of cellulite in the thighs using a photography scale Scale: 8 photographies - Grade 0 to Grade 8; Hiher the grade is, more there is cellulite.

Trial Locations

Locations (1)

GREDECO; 🇫🇷 Paris, France