Status:
COMPLETED
LIFEHOUSE: Description of the Tent Bucket -Immune Support
Lead Sponsor:
Metagenics, Inc.
Collaborating Sponsors:
MetaProteomics LLC
Conditions:
Immune Response
Eligibility:
All Genders
18-69 years
Phase:
NA
Brief Summary
This immune support program will be an extension to the existing LIFEHOUSE program. Essential employees in Gig Harbor, WA; Colonial Heights, VA; Lenexa, KS, and Santa Fe Springs, CA, will be offered c...
Detailed Description
This program, as a component of the LIFEHOUSE program, will consist of data collection during a period of supplementation with commercially available nutritional supplements supportive of immune healt...
Eligibility Criteria
Inclusion
- Male or Female
- Ages 18-69, inclusive
- Metagenics' employees in Gig Harbor, WA; Colonial Heights, VA; Lenexa, KS, and Santa Fe Springs, CA
- General good health
- Willing to give written informed consent to participate in the study
Exclusion
- An allergy to any ingredient in Vit.D3 5000 and/or Immune Active
- A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, psychiatric, immunologic/rheumatological, or oncological/hematologic disease.
- Hyperparathyroidism
- Granulomatous disorders including as sarcoidosis, tuberculosis, leprosy, berylliosis, histoplasmosis, and coccidioidomycosis
- Chronic renal insufficiency
- Nephrolithiasis
- Prior cancer diagnosis
- Known infection with human immunodeficiency virus (HIV), tuberculosis (TB), or Hepatitis B or C.
- Established psychiatric disease including moderate to severe depression, thought disorders and bipolar disorder
- Planned use of nutritional supplements (exclusive of multiple vitamin/mineral supplements and medical foods) containing in total more than 1,000 IU Vitamin D3 and/or 10 mg Zinc
- Use of pharmaceutical nitrates for any indication
- Use of drugs of abuse and recreational drugs/substances (such as but not limited to opioids, cocaine, phencyclidine (PCP), and methamphetamine)
- History of marijuana or cannabinoid abuse within 12 months prior to screening and for the duration of the study.
- History of alcohol abuse or a diagnosis of alcoholism within 12 months prior to screening and for the duration of the study.
- Pregnant or breastfeeding women
- Inability to comply with study and/or follow-up visits.
- Any concurrent condition (including clinically significant abnormalities in medical history, physical examination or laboratory evaluations) which, in the opinion of the Principal Investigator (PI), would preclude safe participation in this study or interfere with compliance.
- Any sound medical, psychiatric, and/or social reason which, in the opinion of the PI, would preclude safe participation in this study or interfere with compliance.
Key Trial Info
Start Date :
January 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04734288
Start Date
January 22 2021
End Date
December 31 2022
Last Update
October 30 2023
Active Locations (1)
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1
Personalized Lifestyle Medicine Center
Gig Harbor, Washington, United States, 98332