The Impact of a Human Breast Milk Supplement on Epigenetic and Cellular Markers

Study Overview
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Brief Summary
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This is a trial to assess the effects of the Trulacta supplement on biological age, sleep quality, immune system and wellness markers.

Detailed Description
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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.

Official Title
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The Impact of a Human Breast Milk Supplement on Epigenetic and Cellular Markers

Conditions
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Aging

Intervention / Treatment
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* Dietary Supplement: Trulacta breastmilk supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: single arm, prospective
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trulacta breastmilk supplement<br>Once daily Trulacta supplement | Dietary Supplement: Trulacta breastmilk supplement<br>* one supplement daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epigenetic Age | DNA methylation testing completed with 850kEPIC array | Testing will compare results from baseline to completion of 3 months of the supplement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality | Patients will complete the Pittsburgh Sleep Quality Index (PSQI) at baseline, monthly, and after completing the intervention | Assessment will compare baseline with testing completed after 3 months of the supplement |