Safety and Efficacy of a Dietary Supplement in Females With Cellulite

NCT ID: NCT01321268

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-07-31

Brief Summary

To investigate the safety and efficacy of a dietary supplement on cellulite alleviation, fat deposits and quality of life.

Detailed Description

The study will be conducted as a single centre, randomized, double-blind, controlled, parallel group study with healthy female volunteers, aged 18-45 years of age, with skin phototypes I to VI and a clinical diagnosis of cellulite on buttocks (at least score 6 at Cellulite Severity Scale (CSS)).

The study will take 24 weeks (6 months) per subject. There will be one previsit during the screening phase and 8 visits per subject during the treatment phase.

Safety and efficacy variables will be performed monthly.

Conditions

Cellulite (Orange Peel Skin)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

dietary supplement for cellulite

PUFA, resveratrol, lycopene, beta carotene, lutein

Group Type: EXPERIMENTAL

dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein)

Intervention Type: DIETARY_SUPPLEMENT

oral, twice daily in morning and evening for 6 months

Control

Vitamin E

Group Type: ACTIVE_COMPARATOR

Viatmin E

Intervention Type: DIETARY_SUPPLEMENT

oral, twice daily in morning and evening for 6 months

Interventions

dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein)

oral, twice daily in morning and evening for 6 months

Intervention Type: DIETARY_SUPPLEMENT

Viatmin E

oral, twice daily in morning and evening for 6 months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Healthy female volunteers
• Age between 18 and 45 years at Day 01 of the study
• Body mass index (BMI) from 18.5 -24.9
• All Fitzpatrick skin types
• CSS score of at least 6
• Normal eating habits (no vegetarians or vegans)
• Written informed consent

Exclusion Criteria

• Menopause and pre-menopause
• Smoking
• Pregnant women or women intending to become pregnant during study
• Lactation period
• Any kind of dermatological conditions
• Vegetarians or vegans
• Any kind of hepatitis, including any alteration in transaminases
• Use of illicit drugs
• Other surgical or internal diseases e.g. a metabolic or endocrine disease that may affect the outcome of the study (e.g. diabetes, liver diseases, kidney disorders) or having a history of medical or surgical events that may significantly affect the study outcome including any cardiovascular disease, skin disease, hypertension (>160/95 mm Hg at repeated measurements)
• Existence of scars and/or pigmentation in measurement areas (thighs and buttocks), which can influence study measurements
• Participation in any other clinical trial including blood sampling and/or administration or substances up to 30 days before Day 01 of this study
• Any prior aesthetic surgery (Liposuction, Subcision®), 3 months before the study, that may interfere with results
• Any other prior anti-cellulite treatment or body measures treatment, 30 days prior to the study
• Participation in any other non-invasive clinical trial up to 30 days before Day 01 of this study, including blood sampling
• Recent blood or plasmapherese donation (less than 1 month prior to Day 01 of the study)
• Under medical treatment for a skin disease in the past and/or present with a therapy, which may influence the results of the study (systemic steroids or antibiotics, local steroids or topical immunomodulators during the last 3 months
• Use of sun beds or self-tanning products or sun exposure for one month before and during study
• Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner
• Subjects intending to initiate any intensive sports
• Every other condition that the investigator might consider to involve a risk for the study subject.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Doris M Hexsel, MD

Role: PRINCIPAL_INVESTIGATOR

Brazilian Center for Studies in Dermatology (CBED)

Locations

CBED: Brazilian Center for Studies in dermatology

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

2009-11-03-CEL

Identifier Type: -

Identifier Source: org_study_id