AgingPhase 2NCT05297097
The Impact of a Human Breast Milk Supplement on Epigenetic and Cellular Markers
A Phase 2 study testing Trulacta breastmilk supplement in people with Aging, run by TruDiagnostic at 1 site in United States.
Trial summary
This is a trial to assess the effects of the Trulacta supplement on biological age, sleep quality, immune system and wellness markers. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Trulacta breastmilk supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 30 Dec 2022
- Phase
- Phase 2
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women of any ethnicity.
- Age Range - 18 - 85 years (inclusive)
- Participant must be able to comply with treatment plan and laboratory tests
- Participant must be able to read, write, and speak English fluently
- Participant must have an established primary care provider
- Participant must be willing and able to consume 2 capsules per day throughout the duration of study period
- Participant must have a mobile telephone and internet connection
Who cannot join
- Patients with a self-reported history of lactose intolerance
- History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- Known immune system issues or immunodeficiency disease
- History of viral illness which could be reactivated by immune downregulation
- Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke) disease
- Diagnosis of a transient ischemic attack in the 6 months prior to screening
Show all 16Show fewer
- Participants infected with hepatitis C or HIV
- Presence of active infection in previous 4 weeks
- Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the Clinical Investigator would render a participant unsuitable to participate in the study
- Unable or unwilling to provide required blood sample for testing
- Current or previous use of known prescription immunomodulating products (e.g. glucocorticoids, TNF-alpha inhibitors) in the month prior to the start of the trial.
- A known history of blood dyscrasias including coagulopathy
- Current pregnancy, planned attempts to conceive during study period or sexually active females not using contraception, as well as lactating/nursing females
- Any person deemed by Clinical Investigator as low likelihood of complying with study protocol (e.g. evidence of history of non-compliance, history of poor follow-up, multiple or complex scheduling conflicts).
- Planned surgical procedure during study period
- Participants who are actively engaged in weight-loss or have started any new medications during the duration of the trial that can potentially interfere with the study, as deemed appropriate by Primary Clinical Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Central Florida Wellness
Orlando, Florida, 32819
Chris Tracy, 407-256-5119, Chris@AdventaBio.com
About this study
This is a trial to assess the effects of the Trulacta supplement on biological age, sleep quality, immune system and wellness markers.
Read the detailed description
Human breast milk has been widely studied in babies, as have certain elements of breast milk in adults. None of those studies, however, address the effectiveness of raw breast milk in adults. Furthermore, Adventa Bioscience's proprietary process of converting breast milk into a powder which is then encapsulated has not been studied. Early customers of the breast milk capsule, Trulacta, have experienced incredible results; from increased sleep, reduced pain and bloating, and reduction or elimination of symptoms caused by severe diseases. An early analysis of Trulacta in partnership with a company 4Life, has shown that the milk powder in Trulacta has a high immunologic activity level with Natural Killer cells in controlled environment.
The purpose of this non-randomized, prospective clinical trial is to evaluate the effect of 90 days of supplementation with a human breast milk supplement on sleep quality, low-grade chronic inflammation, immuno-modulation, metabolic health, and epigenetic aging.
- Conditions
- Aging
- Being tested
- Trulacta breastmilk supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trulacta breastmilk supplementDietary supplement
one supplement daily
| Study group | Role | What they receive |
|---|---|---|
| Trulacta breastmilk supplement | Experimental | Once daily Trulacta supplement Receives: Dietary Supplement: Trulacta breastmilk supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigenetic Age
DNA methylation testing completed with 850kEPIC array
Measured: Testing will compare results from baseline to completion of 3 months of the supplement
Secondary outcomes (1)
Sleep Quality
Patients will complete the Pittsburgh Sleep Quality Index (PSQI) at baseline, monthly, and after completing the intervention
Measured: Assessment will compare baseline with testing completed after 3 months of the supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Mar 2022
- Primary completion1 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm, prospective
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TruDiagnostic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adventa Biosciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297097
- Sponsor's protocol ID
- AB-BMA-001
- Status last verified
- Sep 2022
- First submitted
- 10 Mar 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Esser N, Legrand-Poels S, Piette J, Scheen AJ, Paquot N. Inflammation as a link between obesity, metabolic syndrome and type 2 diabetes. Diabetes Res Clin Pract. 2014 Aug;105(2):141-50. doi: 10.1016/j.diabres.2014.04.006. Epub 2014 Apr 13.
PubMed 24798950Oudi ME, Aouni Z, Mazigh C, Khochkar R, Gazoueni E, Haouela H, Machghoul S. Homocysteine and markers of inflammation in acute coronary syndrome. Exp Clin Cardiol. 2010 Summer;15(2):e25-8.
PubMed 20631860
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Human Breast Milk Supplement on Epigenetic and Cellular Markers
- ClinicalTrials.gov ID
- NCT05297097
- Acronym / sponsor ID
- AB-BMA-001
- Conditions
- Aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- TruDiagnosticIndustry (pharma, biotech, devices)
- Collaborators
- Adventa Biosciences
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 28 Mar 2022 (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.
This is a trial to assess the effects of the Trulacta supplement on biological age, sleep quality, immune system and wellness markers.
Detailed description
Human breast milk has been widely studied in babies, as have certain elements of breast milk in adults. None of those studies, however, address the effectiveness of raw breast milk in adults. Furthermore, Adventa Bioscience's proprietary process of converting breast milk into a powder which is then encapsulated has not been studied. Early customers of the breast milk capsule, Trulacta, have experienced incredible results; from increased sleep, reduced pain and bloating, and reduction or elimination of symptoms caused by severe diseases. An early analysis of Trulacta in partnership with a company 4Life, has shown that the milk powder in Trulacta has a high immunologic activity level with Natural Killer cells in controlled environment.
The purpose of this non-randomized, prospective clinical trial is to evaluate the effect of 90 days of supplementation with a human breast milk supplement on sleep quality, low-grade chronic inflammation, immuno-modulation, metabolic health, and epigenetic aging.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm, prospective
| Arm | Type | Receives |
|---|---|---|
| Trulacta breastmilk supplement | Experimental | Dietary Supplement: Trulacta breastmilk supplementOnce daily Trulacta supplement |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women of any ethnicity.
- Age Range - 18 - 85 years (inclusive)
- Participant must be able to comply with treatment plan and laboratory tests
- Participant must be able to read, write, and speak English fluently
- Participant must have an established primary care provider
Key exclusion criteria (16 listed)
- Patients with a self-reported history of lactose intolerance
- History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- Known immune system issues or immunodeficiency disease
- History of viral illness which could be reactivated by immune downregulation
- Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke) disease
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 |
|---|---|---|
| Trulacta breastmilk supplementone supplement daily | Dietary supplement | Trulacta breastmilk supplement |
Primary outcome
Epigenetic Age
Time frame: Testing will compare results from baseline to completion of 3 months of the supplement
DNA methylation testing completed with 850kEPIC array
1 secondary outcome
Sleep Quality
Time frame: Assessment will compare baseline with testing completed after 3 months of the supplement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Background: PubMed 24798950Esser N, Legrand-Poels S, Piette J, Scheen AJ, Paquot N. Inflammation as a link between obesity, metabolic syndrome and type 2 diabetes. Diabetes Res Clin Pract. 2014 Aug;105(2):141-50. doi: 10.1016/j.diabres.2014.04.006. Epub 2014 Apr 13.
- Background: PubMed 20631860Oudi ME, Aouni Z, Mazigh C, Khochkar R, Gazoueni E, Haouela H, Machghoul S. Homocysteine and markers of inflammation in acute coronary syndrome. Exp Clin Cardiol. 2010 Summer;15(2):e25-8.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trulacta breastmilk supplement in people with Aging, run by TruDiagnostic at 1 site in United States.
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 7 inclusion and 16 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 8 Sep 2022. 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 States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chris Tracy (407-256-5119, Chris@adventabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epigenetic Age (time frame: Testing will compare results from baseline to completion of 3 months of the supplement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05297097, which also lists 2 linked publications.
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 8 Sep 2022.