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

NCT ID: NCT03685656

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-03
• Study Completion Date: 2019-02-13

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.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

ANACA3

ANACA3 slimming gel

Group Type: EXPERIMENTAL

Slimming gel

Intervention Type: OTHER

On the morning, one application per day on each area under study (thighs and abdomen) during 8 weeks.

Placebo

Slimming gel contening no active ingredient

Group Type: PLACEBO_COMPARATOR

Slimming gel placebo

Intervention Type: OTHER

On the morning, one application per day on each area under study (thighs and abdomen) during 8 weeks.

Interventions

Slimming gel

On the morning, one application per day on each area under study (thighs and abdomen) during 8 weeks.

Intervention Type: OTHER

Slimming gel placebo

On the morning, one application per day on each area under study (thighs and abdomen) during 8 weeks.

Intervention Type: OTHER

Other Intervention Names

ANACA3 Le Gel Minceur; Placebo

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Slb Pharma

OTHER

Sponsor Role: collaborator

Nutravalia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GREDECO

Paris, , France

Countries

France

Other Identifiers

EFFANACA3GEL

Identifier Type: -

Identifier Source: org_study_id