Back to results

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

Primary Purpose

Overweight and Obesity

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Slimming gel

Slimming gel placebo

About this trial

This is an interventional other trial for Overweight and Obesity focused on measuring Overweight, Obesity, Slimming gel, Cosmetic product, Waist circumference, Thigh circumference

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

GREDECO

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ANACA3

Placebo

Arm Description

ANACA3 slimming gel

Slimming gel contening no active ingredient

Outcomes

Primary Outcome Measures

Waist circumference

Measure of the waist circumference using a measuring tape.

Secondary Outcome Measures

Waist circumference

Measure of the waist circumference using a measuring tape.

Abdominal circumference

Measure of the abdominal circumference (at the level of the navel) using a measuring tape.

Hip circumference

Measure of the hip circumference using a measuring tape.

Thigh circumference

Measure of thigh circumference using a measuring tape.

Abdominal skinfold using a Harpenden skinfold caliper

Measure of the abdominal skinfold using a Harpenden skinfold caliper

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.

Elasticity and firmness of the abdominal skin

Measure of the elasticity and firmness of the abdominal skin using a cutometer

Full Information

NCT ID

NCT03685656

First Posted

July 16, 2018

Last Updated

February 19, 2019

Sponsor

Nutravalia

Collaborators

Slb Pharma

1. Study Identification

Unique Protocol Identification Number

NCT03685656

Brief Title

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

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

September 3, 2018 (Actual)

Primary Completion Date

February 13, 2019 (Actual)

Study Completion Date

February 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nutravalia

Collaborators

Slb Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity

Keywords

Overweight, Obesity, Slimming gel, Cosmetic product, Waist circumference, Thigh circumference

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

208 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ANACA3

Arm Type

Experimental

Arm Description

ANACA3 slimming gel

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Slimming gel contening no active ingredient

Intervention Type

Other

Intervention Name(s)

Slimming gel

Other Intervention Name(s)

ANACA3 Le Gel Minceur

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Slimming gel placebo

Other Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Waist circumference

Description

Measure of the waist circumference using a measuring tape.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Waist circumference

Description

Measure of the waist circumference using a measuring tape.

Time Frame

2 weeks

Title

Abdominal circumference

Description

Measure of the abdominal circumference (at the level of the navel) using a measuring tape.

Time Frame

2 and 8 weeks

Title

Hip circumference

Description

Measure of the hip circumference using a measuring tape.

Time Frame

2 and 8 weeks

Title

Thigh circumference

Description

Measure of thigh circumference using a measuring tape.

Time Frame

2 and 8 weeks

Title

Abdominal skinfold using a Harpenden skinfold caliper

Description

Measure of the abdominal skinfold using a Harpenden skinfold caliper

Time Frame

2 and 8 weeks

Title

Cellulite

Description

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.

Time Frame

2 and 8 weeks

Title

Elasticity and firmness of the abdominal skin

Description

Measure of the elasticity and firmness of the abdominal skin using a cutometer

Time Frame

2 and 8 weeks

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

GREDECO

City

Paris

ZIP/Postal Code

75013

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs