A Clinical Trial to Evaluate the Effects of Naila's Collagen Marine Plus Food Supplement on Skin Hydration, Elasticity, Fine Lines and Wrinkles, and Hair and Nail Health

Overview

This is a single-group, open-label, virtual (decentralized) clinical trial evaluating the effects of Naila's Collagen Marine Plus Food Supplement on skin hydration, elasticity, firmness, fine lines and wrinkles, and hair and nail health over 12 weeks. Forty healthy adults aged 40-60 years with self-reported mature skin showing early signs of aging will take one sachet of the supplement daily and complete questionnaires at Baseline, Week 4, Week 8, and Week 12. Participants will also submit standardized facial and hair photographs at Baseline and Week 12 for evaluation by a board-certified dermatologist. The primary objectives are to assess changes in skin aging parameters and hair health. Secondary objectives include evaluation of nail health, hair shedding and density, participant-reported satisfaction, and product safety and tolerability.

Interventions

• Dietary supplement Naila's Collagen Marine Plus Food Supplement
  All 40 participants receive Naila's Collagen Marine Plus Food Supplement (one sachet daily, dissolved in approximately 200 mL of water, taken once daily in the morning) for 12 weeks.

Primary outcome measures

• Change in Self-Reported Skin Hydration [Time frame: Baseline to Week 12]
• Change in Self-Reported Skin Elasticity [Time frame: Baseline to Week 12]
• Change in Self-Reported Skin Firmness [Time frame: Baseline to Week 12]
• Change in Self-Reported Fine Lines and Wrinkles [Time frame: Baseline to Week 12]
• Change in Dermatologist-Graded Fine Line and Wrinkle Severity [Time frame: Baseline to Week 12]
• Change in Dermatologist-Graded Skin Firmness [Time frame: Baseline to Week 12]
• Change in Dermatologist-Graded Overall Skin Quality [Time frame: Baseline to Week 12]
• Change in Dermatologist-Graded Hair Parameters [Time frame: Baseline to Week 12]

Secondary outcome measures (8)

• Change in Self-Reported Nail Strength [Time frame: Baseline to Week 12]
• Change in Self-Reported Nail Brittleness [Time frame: Baseline to Week 12]
• Change in Self-Reported Nail Growth Rate [Time frame: Baseline to Week 12]
• Change in Self-Reported Overall Nail Appearance [Time frame: Baseline to Week 12]
• Change in Self-Reported Hair Shedding [Time frame: Baseline to Week 12]
• Change in Self-Reported Hair Thickness and Density [Time frame: Baseline to Week 12]
• Participant-Reported Product Satisfaction and Perceived Global Improvement [Time frame: Week 12]
• Incidence of Adverse Events [Time frame: Baseline through Week 12]

Eligibility criteria

Inclusion criteria

• Healthy adults aged 40-60 years at the time of enrollment.
• Self-reported visible signs of skin aging, including at least one of the following: fine lines, wrinkles, reduced skin firmness or elasticity, or skin dryness.
• Self-reports hair shedding and a desire to improve hair health.
• Willing to take one sachet of the study product daily for 12 weeks as directed.
• Willing to avoid taking any other collagen-containing dietary supplements for the duration of the study.
• Willing to maintain current diet, skincare routine, sleep patterns, and physical activity levels for the duration of the trial.
• Willing and able to submit standardized facial and hair photographs at Baseline and Week 12.
• Has access to a smartphone or digital camera capable of producing photographs.
• Resides in the United States.
• Willing to follow the study protocol and complete all required questionnaires.

Exclusion criteria

• Known allergy or sensitivity to fish, marine-derived products, or any of the study product ingredients (marine collagen, hyaluronic acid, ascorbic acid, biotin).
• Previous diagnosis of a hair loss condition such as alopecia areata, androgenetic alopecia, or telogen effluvium.
• Currently taking any collagen-containing dietary supplements, or planning to start taking any collagen supplements in the next 12 weeks.
• Any current uncontrolled chronic medical condition that would prevent the participant from safely completing the study protocol.
• History of a diagnosed dermatological condition that significantly affects facial skin appearance (e.g., severe eczema, psoriasis, rosacea, or active acne) and could confound assessment of skin aging outcomes.
• Use of prescription retinoids, injectable dermal fillers, botulinum toxin, chemical peels, laser skin treatments, or other professional aesthetic procedures on the face within 3 months prior to enrollment or planned during the study period.
• Currently pregnant, breastfeeding, or planning to become pregnant during the study period.
• Currently participating in another research study or planning to participate in another study during this study's duration.
• Any condition that, in the judgment of the investigator, would make the participant unsuitable for inclusion in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07746076 · GULFB-52447

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗