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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03685656
• Other study ID #: EFFANACA3GEL
• Status: Completed
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: February 13, 2019

Study information

• Verified date: February 2019
• Source: Nutravalia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: February 13, 2019
• Est. primary completion date: February 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Other:
• Slimming gel
On the morning, one application per day on each area under study (thighs and abdomen) during 8 weeks.
• Slimming gel placebo
On the morning, one application per day on each area under study (thighs and abdomen) during 8 weeks.

Locations

Country	Name	City	State
France	GREDECO	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Nutravalia	Slb Pharma

Country where clinical trial is conducted

France, 

Outcome

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