Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| C21-D192 | Other Identifier | SGS Stephens, Inc |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This single-center, randomized, controlled clinical trial is being conducted to assess the efficacy on facial skin appearance of the Sponsor's 5-day meal kit when consumed monthly for 3 cycles over the course of 71 days by women with mild to moderate dry fine lines, lack of smoothness, uneven skin tone, and lack of radiance on the face.
Fasting-mimicking diet (FMD) was developed to mimic the metabolic effects of water-only fasting, while providing modest calories and essential nutrients. It consists of 100% natural ingredients, which are generally regarded as safe (GRAS). It is comprised of bars, soups, and beverages aiming to achieve consistent and effective short-term calorie restriction, while providing adequate micronutrients.
The study will test the efficacy parameters, including clinical grading scores, Corneometer measurement, and Antera image analysis and subject self-assessment, of consuming the test products in place of other food over a 5 day period, for 3 cycles, over the course of 71 days when compared with baseline scores/values, and when compared to the untreated control.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No usage instructions. Continue regular eating habits for the duration of the study. | |
| Fasting Mimicking Diet | Experimental | Use the test products, ProLon(TM) Fasting Mimicking Diet, during the scheduled 5-day period in place of the usual meals (breakfast, lunch, dinner, snack) according to the instructions. Use the test product for 5 days for 3 cycles, beginning on day 1, day 30, and day 60. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting mimicking diet (FMD) | Other | The ProLon(TM) Fasting Mimicking Diet regimen is a meal replacement plan that mimics water only fasting. It consists of 100% natural ingredients, which are generally regarded as safe (GRAS). It is comprised of bars, soups, and beverages aiming to achieve consistent and effective short-term calorie restriction, while providing adequate micronutrients. The very low protein and very low sugar content are essential characteristics of the diet. Complex carbohydrates and polyunsaturated fatty acids are its main components. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical grading of the facial skin | Clinical grading will be assessed on the indicated location on each subject's face using a modified Griffiths 10-point scale according to the following numerical definitions. Half-point scores may be used as necessary to more accurately describe the skin condition:
| Day 0 (baseline) and 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical grading of the facial skin | Clinical grading will be assessed on the indicated location on each subject's face using a modified Griffiths 10-point scale according to the following numerical definitions. Half-point scores may be used as necessary to more accurately describe the skin condition:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Summer Acevedo, PhD | SGS Stephens, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Stephens, Inc | Richardson | Texas | 75081 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Day 0 (baseline) and day 11 |
| Facial skin hydration | Triplicate Corneometer (Corneometer CM 825, Courage + Khazaka electronic GmbH, Köln, Germany) measurements will be taken on the center of each subject's right cheek (at the intersection of lines extending up from the corner of the mouth and horizontally across the bottom of the nose). The Corneometer measures moisture content in the stratum corneum by an electrical capacitance method. The measurement has no units, but is proportional to the dielectric constant of the surface layers of the skin, and increases as the skin becomes more hydrated. The readings are directly related to the skin's electrical capacitance (picofarads). | Day 0 (baseline) and day 11 |
| Facial skin hydration | Triplicate Corneometer (Corneometer CM 825, Courage + Khazaka electronic GmbH, Köln, Germany) measurements will be taken on the center of each subject's right cheek (at the intersection of lines extending up from the corner of the mouth and horizontally across the bottom of the nose). The Corneometer measures moisture content in the stratum corneum by an electrical capacitance method. The measurement has no units, but is proportional to the dielectric constant of the surface layers of the skin, and increases as the skin becomes more hydrated. The readings are directly related to the skin's electrical capacitance (picofarads). | Day 0 (baseline) and day 71 |
| Digital Imaging by VISIA | VISIA-CR Imaging (Canfield Imaging Systems, Fairfield, New Jersey) with a Canon Mark II digital SLR camera (Canon Incorporated, Tokyo, Japan). | Day 0 (baseline) and day 11 |
| Digital Imaging by VISIA | VISIA-CR Imaging (Canfield Imaging Systems, Fairfield, New Jersey) with a Canon Mark II digital SLR camera (Canon Incorporated, Tokyo, Japan). | Day 0 (baseline) and day 71 |
| Digital Imaging | Digital Imaging Using Portrait Photo Station (Canon Mark II 7D digital SLR camera (Canon Incorporated, Tokyo, Japan) with a Canon EF-S 60mm f/2.8 macro lens with visible lighting mode.). | Day 0 (baseline) and day 11 |
| Digital Imaging | Digital Imaging Using Portrait Photo Station (Canon Mark II 7D digital SLR camera (Canon Incorporated, Tokyo, Japan) with a Canon EF-S 60mm f/2.8 macro lens with visible lighting mode.). | Day 0 (baseline) and day 71 |
| Digital Imaging for skin roughness | Antera 3D Imaging (Miravex Ltd, Dublin, Ireland). | Day 0 (baseline) and day 11 |
| Digital Imaging for skin roughness | Antera 3D Imaging Procedures (Miravex Ltd, Dublin, Ireland). | Day 0 (baseline) and day 71 |
| Self-assessment | Skin condition self-assessment questionnaire | Day 0 (baseline) and day 11 |
| Self-assessment | Skin condition self-assessment questionnaire on a Likert scale | Day 0 (baseline) and day 71 |