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

• ClinicalTrials.gov Identifier: NCT03685656
• Recruitment Status: Completed
• First Posted: September 26, 2018
• Last Update Posted: February 20, 2019
• Sponsor: Nutravalia
• Collaborator: Slb Pharma
• Information provided by (Responsible Party): Nutravalia

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.

Condition or disease	Intervention/treatment	Phase
Overweight and Obesity	Other: Slimming gel; Other: Slimming gel placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 208 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Randomized, Double-blind, Placebo Controlled Trial of Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers
• Actual Study Start Date: September 3, 2018
• Actual Primary Completion Date: February 13, 2019
• Actual Study Completion Date: February 13, 2019

Arms and Interventions

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 Name: 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 Name: Placebo

Outcome Measures

Primary Outcome Measures :

1. Waist circumference [ Time Frame: 8 weeks ]
   Measure of the waist circumference using a measuring tape.

Secondary Outcome Measures :

1. Waist circumference [ Time Frame: 2 weeks ]
   Measure of the waist circumference using a measuring tape.
2. Abdominal circumference [ Time Frame: 2 and 8 weeks ]
   Measure of the abdominal circumference (at the level of the navel) using a measuring tape.
3. Hip circumference [ Time Frame: 2 and 8 weeks ]
   Measure of the hip circumference using a measuring tape.
4. Thigh circumference [ Time Frame: 2 and 8 weeks ]
   Measure of thigh circumference using a measuring tape.
5. Abdominal skinfold using a Harpenden skinfold caliper [ Time Frame: 2 and 8 weeks ]
   Measure of the abdominal skinfold using a Harpenden skinfold caliper
6. Cellulite [ Time Frame: 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.
7. Elasticity and firmness of the abdominal skin [ Time Frame: 2 and 8 weeks ]
   Measure of the elasticity and firmness of the abdominal skin using a cutometer

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

France

GREDECO

Paris, France, 75013

Sponsors and Collaborators

Nutravalia

Slb Pharma

More Information

• Responsible Party: Nutravalia
• ClinicalTrials.gov Identifier: NCT03685656
• Other Study ID Numbers: EFFANACA3GEL
• First Posted: September 26, 2018
• Last Update Posted: February 20, 2019
• Last Verified: February 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nutravalia:

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

Additional relevant MeSH terms:

Overweight; Body Weight