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NCT Number: NCT06603194

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

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.

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Key information

Conditions

Skin Laxity Alopecia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Hair Diseases Hair Thinning Hypotrichosis Nails Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

35 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Princeton Consumer Research, 8 Richmond Road, Dukes Park

Chelmsford, Essex, CM2 6UA, United Kingdom

Location status: Recruiting

Location contact

Becky Clarke

CONTACT

+441245934050

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bovine or Marine Collagen

Dietary Supplement

Bovine or Marine Collagen

Primary outcomes

  1. Change in nail strength and growth

    Time frame: Baseline, week 6 and week 12

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

  2. Change in skin elasticity

    Time frame: Baseline, week 6 and week 12

    Changes in skin elasticity will be measured by a cutometer

  3. Change in hair thickness and strength

    Time frame: Baseline, week 6 and week 12

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

  4. Change in skin wrinkles

    Time frame: Baseline, week 6 and week 12

    Measurement of the reduction in skin wrinkles using Profilometer

  5. Change in perceived skin health

    Time frame: Baseline, week 6 and week 12

    Changes in perceived skin health assessed by self perception questionnaire

  6. Change in skin wrinkles by visual assessment

    Time frame: Baseline, week 6 and week 12

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

  7. Changes in skin pigmentation

    Time frame: Baseline, week 6 and week 12

    Changes in skin pigmentation will be assessed by Chromameter

  8. Changes in skin hydration

    Time frame: Baseline, week 6 and week 12

    Changes in skin hydration will be assessed by a Corneometer

Secondary outcomes

  1. Digestive Quality of Life (DQDL) Assessment

    Time frame: Baseline, week 6 and week 12

    Participants will complete a Digestive Quality of Life (DQDL) Assessment to evaluate the digestive health benefits

  2. Subjective Perception Questionnaire

    Time frame: Baseline, week 6 and week 12

    Subjective Perception Questionnaire (SPQ) for Whole Body Health to capture participants' self-reported perceptions of their overall health and well-being

Study contacts

Contact information is provided by the study sponsor or research team.

Becky Clarke

CONTACT

[email protected]

Jenna Macciochi, PhD

CONTACT

[email protected]

+447799090189

Sponsors and collaborators

Lead sponsor

Ancient + Brave

Industry

Collaborators

  • Princeton Consumer Research

Registry information

Official study title

BECOME Study: Comparative Efficacy of Bovine and Marine Collagen Versus Placebo on Skin, Hair, Nails and Whole Body Health Markers

Acronym: BECOME

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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