SkinNCT05564624
Effect of Fasting-Mimicking Diet on Skin Health
A study testing Fasting mimicking diet (FMD) in people with Skin, run by L-Nutra Inc at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin
- What is being tested?
- Fasting mimicking diet (FMD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2022to 1 Dec 2022
- 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 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, 35 to 60 years of age.
- In good general health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to subject self-report.
- Having mild to moderate (score of 3-6 according to a modified Griffiths scale,11 where 0=none and 9=severe) scores for the following parameters on the global face: Dry fine lines, Roughness/skin smoothness (visual), Uneven skin tone, Dullness/lack of radiance
- Having a Body Mass Index in the range of 20-35 at the baseline visit.
- Having not had any facial treatments in the past 6 months and are willing to withhold all facial treatments during the course of the study including facials, facial peels, photo facials, laser treatments, dermabrasion, botulinum toxin (Botox®), injectable filler treatments, intense pulsed light (IPL), acid treatments, tightening treatments, facial plastic surgery, or any other treatment administered by a physician or skin care professional designed to improve the appearance or firmness of facial skin. Waxing and threading are allowed but not facial laser hair removal.
Who cannot join
- Having known allergy or sensitivity to food or any component of the meal kit, including nuts, celeriac/celery, oats, and sesame. (Some of the products [bars] are processed in a facility where peanuts, eggs, soy, wheat, milk, and shellfish are also present.)
- Breastfeeding, pregnant, or planning to become pregnant during the study according to subject self-report.
- Having fasted (abstained from food) or having followed a very restricted food plan (eg, a cleanse or fast mimicking diet)for any period of more than 24 hours in the past 90 days.
- Having a history of gastric bypass.
- Having or having a history of a known, suspected, or diagnosed condition of disordered or restricted eating.
- Currently experiencing menopause or having experienced menopause within the last 12 months. 9. Having a history of skin cancer within the past 5 years.
Show all 19Show fewer
- Having a health condition and/or pre-existing or dormant dermatologic disease on the test area/face that the Investigator or designee deems inappropriate for participation or could interfere with the outcome of the study.
- Having observable sunburn, suntan, scars, nevi, excessive hair, tattoos, or other dermal conditions on the test areas that might influence the test results in the opinion of the Investigator or designee.
- Having a history of immunosuppression/immune deficiency disorders, organ transplant, or currently using oral or systemic immunosuppressive medications and biologics and/or undergoing radiation or chemotherapy as determined by study documentation.
- Currently using or having regularly used corticosteroids (systemic or topical, not nasal or ocular) within the past 4 weeks.
- Having or having a history of diabetes, epilepsy, liver failure, advanced chronic kidney disease, heart failure, or syncope (fainting), or other metabolic disorder or serious health condition.
- Having a risk for recurrent infections or currently experiencing a fever, cough, diarrhea, or active yeast infection.
- Having a disease such as asthma, hypertension, hyperthyroidism, or hypothyroidism that is not controlled by diet or medication, or hypertension requiring treatment with more than one medication. Individuals having multiple or severe health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc.
- Having started a long-term medication within the last 2 months.
- Having any planned surgeries or invasive medical procedures during the study (including colonoscopy). Noninvasive medical procedures or surgeries will be reviewed for their impact on the study outcome and acceptability by the Investigator or designee.
- Currently participating in any other clinical trial.
- Having participated in any clinical trial involving the face within 2 weeks before study enrollment.
- Having started hormone replacement therapies (HRT) or hormones for birth control or menopause less than 3 months before study enrollment or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
- Has any medical disease or condition that, in the opinion of the principal investigator (PI) or appropriate study personnel, precludes study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Determine the Facial Skin Benefits of a Periodic Fasting-Mimicking Diet
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.
Read the detailed description
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.
- Conditions
- Skin
- Being tested
- Fasting mimicking diet (FMD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Fasting mimicking diet (FMD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Skin smoothness (visual), cheeks;
- Skin smoothness (tactile), cheeks;
- Dry fine lines, global face;
- Clarity, global face;
- Redness, global face;
- Evenness of skin tone, global face;
- Radiance, global face;
- Overall appearance of skin condition (health)
Measured: Day 0 (baseline) and 71
Secondary outcomes (11)
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:
- Skin smoothness (visual), cheeks;
- Skin smoothness (tactile), cheeks;
- Dry fine lines, global face;
- Clarity, global face;
- Redness, global face;
- Evenness of skin tone, global face;
- Radiance, global face;
- Overall appearance of skin condition (health)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.).
Measured: 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.).
Measured: Day 0 (baseline) and day 71
Digital Imaging for skin roughness
Antera 3D Imaging (Miravex Ltd, Dublin, Ireland).
Measured: Day 0 (baseline) and day 11
Digital Imaging for skin roughness
Antera 3D Imaging Procedures (Miravex Ltd, Dublin, Ireland).
Measured: Day 0 (baseline) and day 71
Self-assessment
Skin condition self-assessment questionnaire
Measured: Day 0 (baseline) and day 11
Self-assessment
Skin condition self-assessment questionnaire on a Likert scale
Measured: Day 0 (baseline) and day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start6 Jan 2022
- Primary completion1 Oct 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SkinStudies 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
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- L-Nutra Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Summer Acevedo, PhD, Principal investigator, SGS Stephens, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564624
- Sponsor's protocol ID
- LNT21-006
- Other IDs
- C21-D192
- Status last verified
- Oct 2023
- First submitted
- 18 Sep 2022
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Determine the Facial Skin Benefits of a Periodic Fasting-Mimicking Diet
- ClinicalTrials.gov ID
- NCT05564624
- Acronym / sponsor ID
- LNT21-006
- Conditions
- Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- L-Nutra IncIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 3 Oct 2022 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No usage instructions. Continue regular eating habits for the duration of the study. |
| Fasting Mimicking Diet | Experimental | Other: Fasting mimicking diet (FMD)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. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female, 35 to 60 years of age.
- In good general health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to subject self-report.
- Having mild to moderate (score of 3-6 according to a modified Griffiths scale,11 where 0=none and 9=severe) scores for the following parameters on the global face: Dry fine lines, Roughness/skin smoothness (visual), Uneven skin tone, Dullness/lack of radiance
- Having a Body Mass Index in the range of 20-35 at the baseline visit.
- Having not had any facial treatments in the past 6 months and are willing to withhold all facial treatments during the course of the study including facials, facial peels, photo facials, laser treatments, dermabrasion, botulinum toxin (Botox®), injectable filler treatments, intense pulsed light (IPL), acid treatments, tightening treatments, facial plastic surgery, or any other treatment administered by a physician or skin care professional designed to improve the appearance or firmness of facial skin. Waxing and threading are allowed but not facial laser hair removal.
Key exclusion criteria (19 listed)
- Having known allergy or sensitivity to food or any component of the meal kit, including nuts, celeriac/celery, oats, and sesame. (Some of the products [bars] are processed in a facility where peanuts, eggs, soy, wheat, milk, and shellfish are also present.)
- Breastfeeding, pregnant, or planning to become pregnant during the study according to subject self-report.
- Having fasted (abstained from food) or having followed a very restricted food plan (eg, a cleanse or fast mimicking diet)for any period of more than 24 hours in the past 90 days.
- Having a history of gastric bypass.
- Having or having a history of a known, suspected, or diagnosed condition of disordered or restricted eating.
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 |
|---|---|---|
| Fasting mimicking diet (FMD)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. | Other | Fasting Mimicking Diet |
Primary outcome
Clinical grading of the facial skin
Time frame: Day 0 (baseline) and 71
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: 1. Skin smoothness (visual), cheeks; 2. Skin smoothness (tactile), cheeks; 3. Dry fine lines, global face; 4. Clarity, global face; 5. Redness, global face; 6. Evenness of skin tone, global face; 7. Radiance, global face; 8. Overall appearance of skin condition (health)
11 secondary outcomes
Clinical grading of the facial skin
Time frame: Day 0 (baseline) and day 11
Facial skin hydration
Time frame: Day 0 (baseline) and day 11
Facial skin hydration
Time frame: Day 0 (baseline) and day 71
Digital Imaging by VISIA
Time frame: Day 0 (baseline) and day 11
Digital Imaging by VISIA
Time frame: Day 0 (baseline) and day 71
Digital Imaging
Time frame: Day 0 (baseline) and day 11
Digital Imaging
Time frame: Day 0 (baseline) and day 71
Digital Imaging for skin roughness
Time frame: Day 0 (baseline) and day 11
Digital Imaging for skin roughness
Time frame: Day 0 (baseline) and day 71
Self-assessment
Time frame: Day 0 (baseline) and day 11
Self-assessment
Time frame: Day 0 (baseline) and day 71
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 26 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Summer Acevedo, PhD principal investigator
SGS Stephens, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting mimicking diet (FMD) in people with Skin, run by L-Nutra Inc at 1 site in United States.
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 5 inclusion and 19 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 26 Oct 2023. 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 United States. 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. 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?
Clinical grading of the facial skin (time frame: Day 0 (baseline) and 71). 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 26 Oct 2023.