Overweight and ObesityNCT03685656
Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers
A study testing Slimming gel in people with Overweight and Obesity, run by Nutravalia at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Slimming gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2018to 13 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo Controlled Trial of 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.
Read more
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
- Being tested
- Slimming gel, Slimming gel placebo
- Keywords
- Overweight, Obesity, Slimming gel, Cosmetic product, Waist circumference, Thigh circumference
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slimming gelOther
Also called ANACA3 Le Gel Minceur
On the morning, one application per day on each area under study (thighs and abdomen) during 8 weeks.
Slimming gel placeboOther
Also called Placebo
On the morning, one application per day on each area under study (thighs and abdomen) during 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ANACA3 | Experimental | ANACA3 slimming gel Receives: Other: Slimming gel |
| Placebo | Placebo comparator | Slimming gel contening no active ingredient Receives: Other: Slimming gel placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference
Measure of the waist circumference using a measuring tape.
Measured: 8 weeks
Secondary outcomes (7)
Waist circumference
Measure of the waist circumference using a measuring tape.
Measured: 2 weeks
Abdominal circumference
Measure of the abdominal circumference (at the level of the navel) using a measuring tape.
Measured: 2 and 8 weeks
Hip circumference
Measure of the hip circumference using a measuring tape.
Measured: 2 and 8 weeks
Thigh circumference
Measure of thigh circumference using a measuring tape.
Measured: 2 and 8 weeks
Abdominal skinfold using a Harpenden skinfold caliper
Measure of the abdominal skinfold using a Harpenden skinfold caliper
Measured: 2 and 8 weeks
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.
Measured: 2 and 8 weeks
Elasticity and firmness of the abdominal skin
Measure of the elasticity and firmness of the abdominal skin using a cutometer
Measured: 2 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start3 Sep 2018
- Primary completion13 Feb 2019
- Study completion13 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutravalia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685656
- Sponsor's protocol ID
- EFFANACA3GEL
- Status last verified
- Feb 2019
- First submitted
- 16 Jul 2018
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo Controlled Trial of Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03685656
- Acronym / sponsor ID
- EFFANACA3GEL
- Conditions
- Overweight and Obesity
- Keywords
- Overweight, Obesity, Slimming gel, Cosmetic product, Waist circumference, Thigh circumference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- NutravaliaIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANACA3 | Experimental | Other: Slimming gelANACA3 slimming gel |
| Placebo | Placebo comparator | Other: Slimming gel placeboSlimming gel contening no active ingredient |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slimming gelAlso: ANACA3 Le Gel MinceurOn the morning, one application per day on each area under study (thighs and abdomen) during 8 weeks. | Other | ANACA3 |
| Slimming gel placeboAlso: PlaceboOn the morning, one application per day on each area under study (thighs and abdomen) during 8 weeks. | Other | Placebo |
Primary outcome
Waist circumference
Time frame: 8 weeks
Measure of the waist circumference using a measuring tape.
7 secondary outcomes
Waist circumference
Time frame: 2 weeks
Abdominal circumference
Time frame: 2 and 8 weeks
Hip circumference
Time frame: 2 and 8 weeks
Thigh circumference
Time frame: 2 and 8 weeks
Abdominal skinfold using a Harpenden skinfold caliper
Time frame: 2 and 8 weeks
Cellulite
Time frame: 2 and 8 weeks
Elasticity and firmness of the abdominal skin
Time frame: 2 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slimming gel in people with Overweight and Obesity, run by Nutravalia at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist circumference (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.