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OpenTrials
Completed

NCT Number: NCT03685656

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

GREDECO

Paris, 75013, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Slimming gel

Other

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

Other names: ANACA3 Le Gel Minceur

Slimming gel placebo

Other

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

Other names: Placebo

Primary outcomes

  1. Waist circumference

    Time frame: 8 weeks

    Measure of the waist circumference using a measuring tape.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nutravalia

Industry

Collaborators

  • Slb Pharma

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 26, 2018
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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