Benefit of Bovine or Marine Collagen Vs. Placebo on Skin, Hair, Nails and Whole Body Health in Healthy Adults

NCT06603194 | Recruiting

• 1 other identifier: AABVIV1C
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Laxity; Hair Thinning; Nails

Keywords

Collagen; Skin health; Skin density

Outcome Measures

Primary Outcomes (8)

• Change in nail strength and growth

  Assessment of nail strength and growth will be assessed by self-perception questionnaire

  Baseline, week 6 and week 12

• Change in skin elasticity

  Changes in skin elasticity will be measured by a cutometer

  Baseline, week 6 and week 12

• Change in hair thickness and strength

  Strength and breakage of hair will be assessed by self perception questionnaire

  Baseline, week 6 and week 12

• Change in skin wrinkles

  Measurement of the reduction in skin wrinkles using Profilometer

  Baseline, week 6 and week 12

• Change in perceived skin health

  Changes in perceived skin health assessed by self perception questionnaire

  Baseline, week 6 and week 12

• Change in skin wrinkles by visual assessment

  Change in skin wrinkles will be performed by visual assessment by a dermatologist

  Baseline, week 6 and week 12

• Changes in skin pigmentation

  Changes in skin pigmentation will be assessed by Chromameter

  Baseline, week 6 and week 12

• Changes in skin hydration

  Changes in skin hydration will be assessed by a Corneometer

  Baseline, week 6 and week 12

Secondary Outcomes (2)

• Digestive Quality of Life (DQDL) Assessment

  Baseline, week 6 and week 12

• Subjective Perception Questionnaire

  Baseline, week 6 and week 12

Study Arms (3)

Bovine Collagen

ACTIVE COMPARATOR

10g powder format taken daily for duration of the study.

Dietary Supplement: Bovine or Marine Collagen

Marine Collagen

ACTIVE COMPARATOR

10g powder format taken daily for duration of the study.

Dietary Supplement: Bovine or Marine Collagen

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Bovine or Marine Collagen

Interventions

Bovine or Marine Collagen DIETARY_SUPPLEMENT

Bovine or Marine Collagen

Bovine Collagen; Marine Collagen; Placebo

Eligibility Criteria

• Age: 35 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ancient + Brave: lead
• Princeton Consumer Research: collaborator

Study Sites (1)

Princeton Consumer Research, 8 Richmond Road, Dukes Park

Chelmsford, Essex, CM2 6UA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cutis Laxa; Alopecia

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jenna Macciochi, PhD

  jenna@ancientandbrave.earth

  PRINCIPAL INVESTIGATOR

• Becky Clarke

  Princeton Consumer Research

  STUDY DIRECTOR

Central Study Contacts

Jenna Macciochi, PhD

CONTACT

+447799090189; jenna@ancientandbrave.earth

Becky Clarke

CONTACT

beckyclarke@princetonconsumer.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 19, 2024
• Study Start: August 26, 2024
• Primary Completion: November 25, 2024
• Study Completion: December 20, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

GB (1)