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

TruDiagnostic

Status and phase

Enrolling

Phase 2

Conditions

Aging

Treatments

Dietary Supplement: Trulacta breastmilk supplement

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT05297097

AB-BMA-001

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.