Clinical trial NCT04734288: LIFEHOUSE: Description of the Tent Bucket -Immune Support
Official title: LIFEHOUSE: a Lifestyle Intervention and Functional Evaluation- a Health OUtcome SurvEy; Description of the Tent Bucket -Immune Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Response
Keywords: Nutritional Supplements
Vitamin (Vit.) D3
hs-CRP
Inflammation
Employee wellness program
Lead sponsor: Metagenics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: MetaProteomics LLC
First posted: 2021-02-02
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm cohort intervention study
Primary purpose: SUPPORTIVE_CARE

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 complimentary supplementation with commercially available nutritional supplements supportive of immune health for several months. The outcome will be measured via blood parameters and questionnaire responses.

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 health. Employees, in Gig Harbor, WA; Colonial Heights, VA; Lenexa, KS, and Santa Fe Springs, CA, will be offered the opportunity to participate.

The nutritional and inflammatory status will be captured via fingerstick biomarkers. Participants will receive in-home testing kits including instructions regarding the applicable fingerstick blood collections. Fingerstick testing will include 25-Hydroxy Vitamin D3 (25-OH D3) and high sensitivity c-reactive protein (hs-CRP) measurements at baseline, 1, and 2 (phase 1), or at baseline 1,2, 3, and 6 months intervals (phase 2).

Participants will also be asked to complete applicable questionnaires (QNs) electronically monthly using standard software programs for questionnaire completion.

This will include the Medical Outcome Study (MOS) Short Form (SF) -36 (baseline and monthly) and Health Status QNs including questions on compliance, wellbeing, lifestyle (exercise, shifts worked, medications and supplements, and diet) (baseline and monthly).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of health.
timeFrame: 12 weeks (Phase 1) or up to 6 months (Phase 2)
Secondary outcomes:
measure: The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of quality of life.
timeFrame: 12 weeks (Phase 1) or up to 6 months (Phase 2)
measure: The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of the absence of infections.
timeFrame: 12 weeks (Phase 1) or up to 6 months (Phase 2)
measure: The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of weight and body composition.
timeFrame: 12 weeks (Phase 1) or up to 6 months (Phase 2)
Other outcomes:
Locations:
city: Gig Harbor
country: United States
facility: Personalized Lifestyle Medicine Center
state: Washington
Study officials:
affiliation: Medical Director
name: Josesph J Lamb, MD
role: PRINCIPAL_INVESTIGATOR
References: