Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Adventa Biosciences | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
This is a trial to assess the effects of the Trulacta supplement on biological age, sleep quality, immune system and wellness markers.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trulacta breastmilk supplement | Experimental | Once daily Trulacta supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trulacta breastmilk supplement | Dietary Supplement | one supplement daily |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chris Tracy | Contact | 407-256-5119 | Chris@adventabio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Florida Wellness | Recruiting | Orlando | Florida | 32819 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24798950 | Background | 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. | |
| 20631860 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
single arm, prospective
Not provided
Not provided
Not provided
Not provided