Clinical trial NCT06603194: Benefit of Bovine or Marine Collagen Vs. Placebo on Skin, Hair, Nails and Whole Body Health in Healthy Adults
Official title: BECOME Study: Comparative Efficacy of Bovine and Marine Collagen Versus Placebo on Skin, Hair, Nails and Whole Body Health Markers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Laxity
Hair Thinning
Nails
Keywords: Collagen
Skin health
Skin density
Lead sponsor: Ancient + Brave
Sponsor class: INDUSTRY
Collaborators: name: Princeton Consumer Research
First posted: 2024-09-19
Enrollment: 90
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The BECOME Study (Bovine and Marine Collagen Efficacy for Skin, Hair, Nails and Whole Body Health Markers Evaluation) is a randomized controlled trial designed to compare the effects of bovine and marine collagen supplements versus a placebo on skin, hair, nails and whole body health markers. The trial aims to determine the most efficacious collagen source for improving health outcomes and to establish if both types of collagen are equally effective. Participants will be assessed on various health parameters, including skin elasticity, joint health, digestive health, and overall well-being, over a specified period.


Eligibility criteria: Inclusion Criteria:

Females aged 35-55 years. Participants must be comfortable with bovine or marine collagen (non-vegan/vegetarian).

Must provide informed consent and be willing to comply with study requirements.

Exclusion Criteria:

Pregnant or breastfeeding women. History of chronic skin conditions (e.g., eczema, psoriasis) that might interfere with study outcomes.

Any active skin infections or severe acne. Currently taking collagen supplements or have taken them within the last 6 months.

Use of medications or topical agents that can affect skin, hair, nails, or gastrointestinal health (e.g., corticosteroids, retinoids).

Excessive alcohol consumption or current smokers. Regular use of sunbeds. Recent cosmetic procedures (e.g., Botox, fillers, chemical peels, laser treatments) on skin, hair, or nails within the last 3 months.

Any condition or situation that, in the opinion of the investigator, may interfere with the participant's ability to comply with the study requirements or give informed consent.

Poor adherence to previous study protocols

Primary outcomes:
measure: Change in nail strength and growth
timeFrame: Baseline, week 6 and week 12
measure: Change in skin elasticity
timeFrame: Baseline, week 6 and week 12
measure: Change in hair thickness and strength
timeFrame: Baseline, week 6 and week 12
measure: Change in skin wrinkles
timeFrame: Baseline, week 6 and week 12
measure: Change in perceived skin health
timeFrame: Baseline, week 6 and week 12
measure: Change in skin wrinkles by visual assessment
timeFrame: Baseline, week 6 and week 12
measure: Changes in skin pigmentation
timeFrame: Baseline, week 6 and week 12
measure: Changes in skin hydration
timeFrame: Baseline, week 6 and week 12
Secondary outcomes:
measure: Digestive Quality of Life (DQDL) Assessment
timeFrame: Baseline, week 6 and week 12
measure: Subjective Perception Questionnaire
timeFrame: Baseline, week 6 and week 12
Other outcomes:
Locations:
city: Chelmsford
country: United Kingdom
facility: Princeton Consumer Research, 8 Richmond Road, Dukes Park
state: Essex
Study officials:
affiliation: jenna@ancientandbrave.earth
name: Jenna Macciochi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Princeton Consumer Research
name: Becky Clarke
role: STUDY_DIRECTOR
References: