Clinical trial NCT05564624: Effect of Fasting-Mimicking Diet on Skin Health
Official title: A Clinical Study to Determine the Facial Skin Benefits of a Periodic Fasting-Mimicking Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin
Lead sponsor: L-Nutra Inc
Sponsor class: INDUSTRY
First posted: 2022-10-03
Enrollment: 45
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Female, 35 to 60 years of age.
2. In good general health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to subject self-report.
3. 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
4. Having a Body Mass Index in the range of 20-35 at the baseline visit.
5. 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.

Exclusion Criteria:

1. 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.)
2. Breastfeeding, pregnant, or planning to become pregnant during the study according to subject self-report.
3. 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.
4. Having a history of gastric bypass.
5. Having or having a history of a known, suspected, or diagnosed condition of disordered or restricted eating.
6. Currently experiencing menopause or having experienced menopause within the last 12 months. 9. Having a history of skin cancer within the past 5 years.
7. 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.
8. 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.
9. 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.
10. Currently using or having regularly used corticosteroids (systemic or topical, not nasal or ocular) within the past 4 weeks.
11. 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.
12. Having a risk for recurrent infections or currently experiencing a fever, cough, diarrhea, or active yeast infection.
13. 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.
14. Having started a long-term medication within the last 2 months.
15. 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.
16. Currently participating in any other clinical trial.
17. Having participated in any clinical trial involving the face within 2 weeks before study enrollment.
18. 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.
19. Has any medical disease or condition that, in the opinion of the principal investigator (PI) or appropriate study personnel, precludes study participation.

Primary outcomes:
measure: Clinical grading of the facial skin
timeFrame: Day 0 (baseline) and 71
Secondary outcomes:
measure: Clinical grading of the facial skin
timeFrame: Day 0 (baseline) and day 11
measure: Facial skin hydration
timeFrame: Day 0 (baseline) and day 11
measure: Facial skin hydration
timeFrame: Day 0 (baseline) and day 71
measure: Digital Imaging by VISIA
timeFrame: Day 0 (baseline) and day 11
measure: Digital Imaging by VISIA
timeFrame: Day 0 (baseline) and day 71
measure: Digital Imaging
timeFrame: Day 0 (baseline) and day 11
measure: Digital Imaging
timeFrame: Day 0 (baseline) and day 71
measure: Digital Imaging for skin roughness
timeFrame: Day 0 (baseline) and day 11
measure: Digital Imaging for skin roughness
timeFrame: Day 0 (baseline) and day 71
measure: Self-assessment
timeFrame: Day 0 (baseline) and day 11
measure: Self-assessment
timeFrame: Day 0 (baseline) and day 71
Other outcomes:
Locations:
city: Richardson
country: United States
facility: SGS Stephens, Inc
state: Texas
Study officials:
affiliation: SGS Stephens, Inc
name: Summer Acevedo, PhD
role: PRINCIPAL_INVESTIGATOR
References: