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

Randomized, Double-blind, Placebo Controlled Trial of Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Other: Slimming gel; Other: Slimming gel placebo

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • GREDECO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ANACA3; ANACA3 slimming gel	Other: Slimming gel; On the morning, one application per day on each area under study (thighs and abdomen) during 8 weeks.; Other Names: ANACA3 Le Gel Minceur
PLACEBO_COMPARATOR: Placebo; Slimming gel contening no active ingredient	Other: Slimming gel placebo; On the morning, one application per day on each area under study (thighs and abdomen) during 8 weeks.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference	Measure of the waist circumference using a measuring tape.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference	Measure of the waist circumference using a measuring tape.	2 weeks
Abdominal circumference	Measure of the abdominal circumference (at the level of the navel) using a measuring tape.	2 and 8 weeks
Hip circumference	Measure of the hip circumference using a measuring tape.	2 and 8 weeks
Thigh circumference	Measure of thigh circumference using a measuring tape.	2 and 8 weeks
Abdominal skinfold using a Harpenden skinfold caliper	Measure of the abdominal skinfold using a Harpenden skinfold caliper	2 and 8 weeks
Cellulite	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.	2 and 8 weeks
Elasticity and firmness of the abdominal skin	Measure of the elasticity and firmness of the abdominal skin using a cutometer	2 and 8 weeks

Collaborators and Investigators

• Sponsor: Nutravalia
• Collaborators: Slb Pharma

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 3, 2018
• Primary Completion (ACTUAL): February 13, 2019
• Study Completion (ACTUAL): February 13, 2019

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (ACTUAL): September 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 20, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Waist circumference; Slimming gel; Cosmetic product; Thigh circumference
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: EFFANACA3GEL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No