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

NCT03685656 | Completed

• 1 other identifier: EFFANACA3GEL
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Waist circumference

  Measure of the waist circumference using a measuring tape.

  8 weeks

Secondary Outcomes (7)

• Waist circumference

  2 weeks

• Abdominal circumference

  2 and 8 weeks

• Hip circumference

  2 and 8 weeks

• Thigh circumference

  2 and 8 weeks

• Abdominal skinfold using a Harpenden skinfold caliper

  2 and 8 weeks

Study Arms (2)

ANACA3

EXPERIMENTAL

ANACA3 slimming gel

Other: Slimming gel

Placebo

PLACEBO COMPARATOR

Slimming gel contening no active ingredient

Other: Slimming gel placebo

Interventions

Slimming gel OTHER

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

Also known as: ANACA3 Le Gel Minceur

ANACA3

Slimming gel placebo OTHER

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

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• Antecedent of surgery for bariatric and / or aesthetic,
• Severe eating disorders (anorexia, bulimia, binge eating, etc.),
• Not affiliated to a Social Security scheme.

Sponsors & Collaborators

• Nutravalia: lead
• Slb Pharma: collaborator

Study Sites (1)

GREDECO

Paris, 75013, France

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: September 26, 2018
• Study Start: September 3, 2018
• Primary Completion: February 13, 2019
• Study Completion: February 13, 2019
• Last Updated: February 20, 2019

Record last verified: 2019-02

Locations

FR (1)