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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Laxity; Hair Thinning; Nails
• Intervention / Treatment: Dietary supplement: Bovine or Marine Collagen

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenna Macciochi, PhD; Phone Number: +447799090189; Email: jenna@ancientandbrave.earth
• Study Contact Backup: Name: Becky Clarke; Email: beckyclarke@princetonconsumer.com

Study Locations

• United Kingdom
  • Essex
    • Chelmsford, Essex, United Kingdom, CM2 6UA
      • Recruiting
      • Princeton Consumer Research, 8 Richmond Road, Dukes Park
      • Contact: Becky Clarke; Phone Number: +441245934050

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Bovine or Marine Collagen; Bovine or Marine Collagen
Active Comparator: Bovine Collagen; 10g powder format taken daily for duration of the study.	Dietary supplement: Bovine or Marine Collagen; Bovine or Marine Collagen
Active Comparator: Marine Collagen; 10g powder format taken daily for duration of the study.	Dietary supplement: Bovine or Marine Collagen; Bovine or Marine Collagen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Digestive Quality of Life (DQDL) Assessment	Participants will complete a Digestive Quality of Life (DQDL) Assessment to evaluate the digestive health benefits	Baseline, week 6 and week 12
Subjective Perception Questionnaire	Subjective Perception Questionnaire (SPQ) for Whole Body Health to capture participants' self-reported perceptions of their overall health and well-being	Baseline, week 6 and week 12

Collaborators and Investigators

• Sponsor: Ancient + Brave
• Collaborators: Princeton Consumer Research
• Investigators: Principal Investigator: Jenna Macciochi, PhD, jenna@ancientandbrave.earth; Study Director: Becky Clarke, Princeton Consumer Research

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Estimated): November 25, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Collagen; Skin health; Skin density
• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Pathological Conditions, Anatomical; Skin Diseases, Genetic; Hair Diseases; Alopecia; Alopecia Areata; Cutis Laxa; Hypotrichosis
• Other Study ID Numbers: AABVIV1C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No