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

Status unconfirmed · Phase 2

Conditions studied: Aging

In brief

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

Key facts

Study ID

NCT05297097

Run by

TruDiagnostic

People needed

30

Starts

2022-03-01

Expected to finish

2022-12-30

Last updated by the study team

2022-09-08

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Central Florida Wellness — Orlando, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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