Skin LaxityBECOMENCT06603194
Benefit of Bovine or Marine Collagen Vs. Placebo on Skin, Hair, Nails and Whole Body Health in Healthy Adults
A study testing Bovine or Marine Collagen in people with Skin Laxity and Hair Thinning, run by Ancient + Brave at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity, Hair Thinning, Nails
- What is being tested?
- Bovine or Marine Collagen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Aug 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Becky Clarke contact
United Kingdom1 site, 1 recruiting
- Recruiting
Princeton Consumer Research, 8 Richmond Road, Dukes Park
Chelmsford, Essex, CM2 6UA
Becky Clarke, +441245934050
About this study
Official title: 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.
- Conditions
- Skin Laxity, Hair Thinning, Nails
- Being tested
- Bovine or Marine Collagen
- Keywords
- Collagen, Skin health, Skin density
- Medical subject headings
- Cutis Laxa, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bovine or Marine CollagenDietary supplement
Bovine or Marine Collagen
| Study group | Role | What they receive |
|---|---|---|
| Bovine Collagen | Active comparator | 10g powder format taken daily for duration of the study. Receives: Dietary Supplement: Bovine or Marine Collagen |
| Marine Collagen | Active comparator | 10g powder format taken daily for duration of the study. Receives: Dietary Supplement: Bovine or Marine Collagen |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Bovine or Marine Collagen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nail strength and growth
Assessment of nail strength and growth will be assessed by self-perception questionnaire
Measured: Baseline, week 6 and week 12
Change in skin elasticity
Changes in skin elasticity will be measured by a cutometer
Measured: Baseline, week 6 and week 12
Change in hair thickness and strength
Strength and breakage of hair will be assessed by self perception questionnaire
Measured: Baseline, week 6 and week 12
Change in skin wrinkles
Measurement of the reduction in skin wrinkles using Profilometer
Measured: Baseline, week 6 and week 12
Change in perceived skin health
Changes in perceived skin health assessed by self perception questionnaire
Measured: 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
Measured: Baseline, week 6 and week 12
Changes in skin pigmentation
Changes in skin pigmentation will be assessed by Chromameter
Measured: Baseline, week 6 and week 12
Changes in skin hydration
Changes in skin hydration will be assessed by a Corneometer
Measured: Baseline, week 6 and week 12
Secondary outcomes (2)
Digestive Quality of Life (DQDL) Assessment
Participants will complete a Digestive Quality of Life (DQDL) Assessment to evaluate the digestive health benefits
Measured: 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
Measured: Baseline, week 6 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start26 Aug 2024
- Primary completion25 Nov 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ancient + Brave
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Princeton Consumer Research
- Responsible party
- Sponsor
- Investigators
- Jenna Macciochi, PhD, Principal investigator, jenna@ancientandbrave.earthBecky Clarke, Study director, Princeton Consumer Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603194
- Sponsor's protocol ID
- AABVIV1C
- Acronym
- BECOME
- Status last verified
- Sep 2024
- First submitted
- 28 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BECOME Study: Comparative Efficacy of Bovine and Marine Collagen Versus Placebo on Skin, Hair, Nails and Whole Body Health Markers
- ClinicalTrials.gov ID
- NCT06603194
- Acronym / sponsor ID
- BECOME / AABVIV1C
- Conditions
- Skin Laxity, Hair Thinning, Nails
- Keywords
- Collagen, Skin health, Skin density
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ancient + BraveIndustry (pharma, biotech, devices)
- Collaborators
- Princeton Consumer Research
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 25 Nov 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bovine Collagen | Active comparator | Dietary Supplement: Bovine or Marine Collagen10g powder format taken daily for duration of the study. |
| Marine Collagen | Active comparator | Dietary Supplement: Bovine or Marine Collagen10g powder format taken daily for duration of the study. |
| Placebo | Placebo comparator | Dietary Supplement: Bovine or Marine Collagen |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bovine or Marine CollagenBovine or Marine Collagen | Dietary supplement | Bovine Collagen, Marine Collagen, Placebo |
Primary outcome
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
Change in skin elasticity
Time frame: Baseline, week 6 and week 12
Changes in skin elasticity will be measured by a cutometer
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
Change in skin wrinkles
Time frame: Baseline, week 6 and week 12
Measurement of the reduction in skin wrinkles using Profilometer
Change in perceived skin health
Time frame: Baseline, week 6 and week 12
Changes in perceived skin health assessed by self perception questionnaire
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
Changes in skin pigmentation
Time frame: Baseline, week 6 and week 12
Changes in skin pigmentation will be assessed by Chromameter
Changes in skin hydration
Time frame: Baseline, week 6 and week 12
Changes in skin hydration will be assessed by a Corneometer
2 secondary outcomes
Digestive Quality of Life (DQDL) Assessment
Time frame: Baseline, week 6 and week 12
Subjective Perception Questionnaire
Time frame: Baseline, week 6 and week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Becky Clarke contact
Jenna Macciochi, PhD principal investigator
jenna@ancientandbrave.earth
Becky Clarke study director
Princeton Consumer Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bovine or Marine Collagen in people with Skin Laxity and Hair Thinning, run by Ancient + Brave at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenna Macciochi, PhD (+447799090189, jenna@ancientandbrave.earth), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nail strength and growth (time frame: Baseline, week 6 and week 12). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.