NCT05297097

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

September 8, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

March 10, 2022

Last Update Submit

September 7, 2022

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

  • Epigenetic Age

    DNA methylation testing completed with 850kEPIC array

    Testing will compare results from baseline to completion of 3 months of the supplement

Secondary Outcomes (1)

  • Sleep Quality

    Assessment will compare baseline with testing completed after 3 months of the supplement

Study Arms (1)

Trulacta breastmilk supplement

EXPERIMENTAL

Once daily Trulacta supplement

Dietary Supplement: Trulacta breastmilk supplement

Interventions

Trulacta breastmilk supplementDIETARY_SUPPLEMENT

one supplement daily

Trulacta breastmilk supplement

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Florida Wellness

Orlando, Florida, 32819, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 24798950BACKGROUND

  • Oudi 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.

    PMID: 20631860BACKGROUND

Central Study Contacts

Chris Tracy

CONTACT

407-256-5119Chris@adventabio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: single arm, prospective
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 28, 2022

Study Start

March 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 30, 2022

Last Updated

September 8, 2022

Record last verified: 2022-09

Locations

US(1)