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

September 16, 2024 updated by: Ancient + Brave

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Baseline, week 6 and week 12
Assessment of nail strength and growth will be assessed by self-perception questionnaire
Baseline, week 6 and week 12
Change in skin elasticity
Time Frame: Baseline, week 6 and week 12
Changes in skin elasticity will be measured by a cutometer
Baseline, week 6 and week 12
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
Baseline, week 6 and week 12
Change in skin wrinkles
Time Frame: Baseline, week 6 and week 12
Measurement of the reduction in skin wrinkles using Profilometer
Baseline, week 6 and week 12
Change in perceived skin health
Time Frame: Baseline, week 6 and week 12
Changes in perceived skin health assessed by self perception questionnaire
Baseline, week 6 and week 12
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
Baseline, week 6 and week 12
Changes in skin pigmentation
Time Frame: Baseline, week 6 and week 12
Changes in skin pigmentation will be assessed by Chromameter
Baseline, week 6 and week 12
Changes in skin hydration
Time Frame: Baseline, week 6 and week 12
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
Time Frame: Baseline, week 6 and week 12
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
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
Baseline, week 6 and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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