Efficacy of a Dietary Supplement on Parameters of Skin Aging in Men and Women

Evaluating the Efficacy of a Dietary Supplement on Parameters of Skin Aging: a 12-Week, Randomized, Double-Blind, Placebo-Controlled Study

As the body ages, the skin experiences natural changes in structure and composition. These changes may manifest visibly as increased skin dryness, wrinkling, and a loss of firmness/elasticity. In this double-blind, randomized, placebo-controlled trial, the investigators will recruit healthy men and women with mild to moderate signs of skin aging and randomly assign them to either receive a HyaCera™ or placebo for 12 weeks. The investigators will perform a series of objective and subjective measurements to assess changes in skin condition. The investigators hypothesize that consumption of HyaCera™ leads to improvements in the general condition of the skin including skin hydration, crow's feet wrinkling, and other skin aging parameters.

Study Overview

• Status: Completed
• Conditions: Skin Aging
• Intervention / Treatment: Dietary supplement: HyaCera™; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Raritan, New Jersey, United States, 08869
      • Princeton Consumer Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male and female volunteers, 25 - 70 years old with mild to moderate fine lines and wrinkles
• All ethnicities and skin types
• Willing to maintain current skincare regimen on face, arms, and legs and withhold all facial and body treatments throughout the course of the study

Exclusion Criteria:

• Self-reported pregnant or breastfeeding or planning to become pregnant during the course of the study
• Any conditions on the face, arms and legs that would interfere with evaluations
• Under treatment for any known health issues/medical conditions including chronic health conditions and skin diseases/conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; Participants receive 1 HyaCera™ capsule orally once daily for 12 weeks	Dietary supplement: HyaCera™; 1 Ritual HyaCera capsule once daily
Placebo Comparator: Placebo; Participants receive 1 placebo capsule orally once daily for 12 weeks	Dietary supplement: Placebo; 1 placebo capsule once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crow's Feet Wrinkles	Degree of crow's feet wrinkling will be measured via Visioscan®	at week 0, Week 4, Week 8, and Week 12
Skin Smoothness	Skin smoothness will be measured via Visioscan®	at week 0, Week 4, Week 8, and Week 12
Skin Hydration	Skin surface hydration will be measured via Corneometer® 825	at week 0, Week 4, Week 8, and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Elasticity	Skin elasticity will be measured via Cutometer® MPA 580	at week 0, Week 4, Week 8, and Week 12
Skin Barrier Function	Skin barrier function (as transepidermal water loss) will be measured via Tewameter®	at week 0, Week 4, Week 8, and Week 12
Skin Scaliness	Skin scaliness will be measured via Visioscan®	at week 0, Week 4, Week 8, and Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermatologist grading of skin condition	Visual and tactile dermatologist evaluation of skin condition (fine lines in the crow's feet area, wrinkles in the crow's feet area, skin dryness, skin radiance, and skin smoothness) based on 10-point grading scale (with 0 being no signs of aging and 9 being the most severe)	at week 0, Week 4, Week 8, and Week 12
Self-evaluation of perceived changes in skin condition	Self-evaluation of changes in skin condition and signs of skin aging (i.e. fine lines & wrinkles, skin texture, skin smoothness, skin plumpness, skin glow/radiance, skin hydration, skin elasticity, skin redness, skin itchiness) using a 5-point Likert scale (options: much worse, somewhat worse, stayed the same, somewhat better, much better)	at week 0, Week 4, Week 8, and Week 12

Collaborators and Investigators

• Sponsor: Natals, Inc. dba Ritual

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Actual): October 6, 2023
• Study Completion (Actual): October 6, 2023

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: dietary supplement; skin hydration; skin aging; skin elasticity; skin barrier function; skin firmness; skin wrinkles; skin smoothness; crow's feet wrinkles
• Other Study ID Numbers: HyaCera2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No