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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    30
  • sponsor
    TruDiagnostic
Updated on 20 September 2022
Accepts healthy volunteers

Summary

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

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.

Details
Condition Aging
Treatment Trulacta breastmilk supplement
Clinical Study IdentifierNCT05297097
SponsorTruDiagnostic
Last Modified on20 September 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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