NCT04734288

LIFEHOUSE: Description of the Tent Bucket -Immune Support

LIFEHOUSE: a Lifestyle Intervention and Functional Evaluation- a Health OUtcome SurvEy; Description of the Tent Bucket -Immune Support

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Metagenics, Inc. · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Accepted

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).

Conditions

• Immune Response

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vit.D3 5000 IU, Immune Active	The subjects will receive monthly (for either 3 or 6 months): 1. Vit.D3 5000 and Immune Active. The first phase includes 3 months of treatment and the second phase includes 6 months of treatment. 2. An in-home Vit.D/ hs-CRP test kit and asked to self-administer a blood collection via fingerstick and return the kits for analysis within a few days. 3. Two online questionnaires each month and asked to fill them out within a few days. It will either be the Medical Outcomes Study (MOS) Short Form (SF)-36 and the Health Status Baseline or Health Status Follow-up Questionnaire.

Timeline

• Start date: 2021-01-22
• Primary completion: 2022-07-31
• Completion: 2022-12-31
• First posted: 2021-02-02
• Last updated: 2023-10-30

Locations

1 site across 1 country: United States