LIFEHOUSE: Description of the Tent Bucket -Immune Support

NCT04734288 | Completed

• 1 other identifier: 2020-002
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Response

Keywords

Nutritional Supplements; Vitamin (Vit.) D3; hs-CRP; Inflammation; Employee wellness program

Outcome Measures

Primary Outcomes (1)

• The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of health.

  The primary objective is to demonstrate the benefit of specific nutritional supplements, Vit.D3 5000 and Immune Active, as measured by demonstrable improvements in health, specifically a marker of nutritional status (25-hydroxy Vitamin D3 (25-OH D3)) and a marker of immune balance (high sensitivity c-reactive protein (hs-CRP) in a real-world setting.

  12 weeks (Phase 1) or up to 6 months (Phase 2)

Secondary Outcomes (3)

• The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of quality of life.

  12 weeks (Phase 1) or up to 6 months (Phase 2)

• The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of the absence of infections.

  12 weeks (Phase 1) or up to 6 months (Phase 2)

• The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of weight and body composition.

  12 weeks (Phase 1) or up to 6 months (Phase 2)

Study Arms (1)

Immune response

EXPERIMENTAL

This is a single-arm study. All subjects will be treated equally and will receive the same type and amount of nutritional supplements.

Dietary Supplement: Vit.D3 5000 IU, Immune Active

Interventions

Vit.D3 5000 IU, Immune Active DIETARY_SUPPLEMENT

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.

Also known as: Test kits- Vit.D and hs-CRP blood measurements, Questionnaires

Immune response

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Metagenics, Inc.: lead
• MetaProteomics LLC: collaborator

Study Sites (1)

Personalized Lifestyle Medicine Center

Gig Harbor, Washington, 98332, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Josesph J Lamb, MD

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single-arm cohort intervention study

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 2, 2021
• Study Start: January 22, 2021
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 30, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)