A Study Investigating the Safety and Efficacy of Bio-Active Silver Hydrosol™ in Providing Immune Support

Sponsor

Natural Immunogenics Corp. (Industry)

Overall Status

Completed

CT.gov ID

NCT04144673

Collaborator

KGK Science Inc. (Industry)

Enrollment

Location

Arms

6.6

Actual Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to investigate the ability of Bio-Active Silver Hydrosol™ in providing immune support in healthy adult males and females participating in intense aerobic exercise. Sixty eligible participants are planned to be randomized into either the investigational product or treatments arms and will consume the study product for 60 days (check-in visit on day 28). Questionnaires will be completed and blood and saliva samples will be collected to measure the endpoints.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Silver Hydrosol Other: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, double-blind, placebo-controlled, parallel studyRandomized, double-blind, placebo-controlled, parallel study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

A Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Safety and Efficacy of Bio-Active Silver Hydrosol™ in Providing Immune Support

Actual Study Start Date :

Nov 14, 2019

Actual Primary Completion Date :

Jun 1, 2020

Actual Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Investigational Product	Other: Silver Hydrosol Silver quantity will be 7 doses per day, with 50 mcg per dose. Other Names: Sovereign Silver, Bio-Active Silver Hydrosol™
Placebo Comparator: Placebo	Other: Placebo Placebo water with no active ingredients

Arm

Intervention/Treatment

Experimental: Investigational Product

Other: Silver Hydrosol

Silver quantity will be 7 doses per day, with 50 mcg per dose.

Other Names:

Sovereign Silver, Bio-Active Silver Hydrosol™

Placebo Comparator: Placebo

Other: Placebo

Placebo water with no active ingredients

Outcome Measures

Primary Outcome Measures

The difference between Bio-Active Silver Hydrosol™ and placebo in the mean global severity index, as measured by area under the curve (AUC) for the WURSS-24 daily symptom scores after 60 days supplementation. [60 days]
The Wisconsin Upper Respiratory Symptom Survey (WURSS) is a questionnaire used to evaluate the negative impact of acute URTIs. The WURSS-24 contains 24 items scored on a Likert-type severity scale. It contains the same items as the WURSS-21 along with headache, body ache, and fever to capture influenza-like illness symptoms. The items are scored on a 0 (do not have this symptom) to 7 (severe) scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Provided voluntary, written, informed consent to participate in the study
Females and males between 19 and 65 years of age inclusive
Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening Or,
Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Double-barrier method
Intrauterine devices
Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
Vasectomy of partner at least 6 months prior to screening
BMI between 18.5 to 29.9 kg/m2 inclusive
Individuals participating in an intense aerobic sport (e.g. cycling, running, triathlon, swimming, soccer, Nordic skiing, basketball, hockey, gym etc.) for greater than or equal to 5 hours a week
Agrees to provide a verbal history of flu vaccination
Healthy as determined by laboratory results, medical history, and physical exam or as determined by the QI
Agrees to maintain current diet and exercise programs
Willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits

Exclusion Criteria:

Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
Subject has a known allergy to the test material's active or inactive ingredients
Verbal confirmation of a diagnosed chronic inflammatory condition
Verbal confirmation of the diagnosis of any autoimmune disease or immune-compromised (i.e. HIV positive, use of anti-rejection medication, rheumatoid arthritis)
Chronic consumption of oral anti-inflammatory medications such as cyclosporine for skin conditions such as psoriasis, dermatitis, rosacea
Chronic consumption of anti-inflammatory medications or medications known to affect immune function on a daily basis, including medications for allergies and asthma with the exception of Ventolin, within 4 weeks of baseline visit (visit 2)
Verbal confirmation of chronic recurring respiratory signs and symptoms due to allergies (including seasonal allergies) or chronic bronchitis
Verbal confirmation of active shingles and/or herpes virus infections, within 2 months of baseline
Use of medical marijuana including THC-free CBD (any form of consumption)
Use of recreational marijuana (any form of consumption) within the past 4 weeks and is unwilling to stop use for the duration of the study
Use of immunomodulators (including corticosteroids) such as immunosuppressant or immune-stimulant medications within 4 weeks of baseline
Taking antibiotics within 2 weeks of screening
Use of immune support supplements unless willing to undergo washout
Use of multivitamins unless on a stable regimen for 3 months as assessed by QI
Verbal confirmation of Type I or Type II diabetes or clinically important hepatic, cardiac, pulmonary, pancreatic, neurologic, or biliary disorder
History or current diagnosis of renal disease with the exception of a history of kidney stones symptom-free for 1 year
Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
Current or pre-existing thyroid condition. Treatment on a stable dose medication for 6 months will be reviewed on a case-by-case basis by the QI
History of or current blood/bleeding disorders with the exception of a history of anemia caused by a deficiency of a mineral or vitamin, and no longer present.
Verbal confirmation of the diagnosis of Hepatitis B/C positive
Chronic unusual sleep routine (examples: irregular routine with frequent late nights, studying, partying)
Use of Prebiotics and Probiotics unless on a stable regimen for 3 months as assessed by QI.
Smoking study participants must be willing to abstain from tobacco use in the morning of a clinical visit
High alcohol intake (average >2 standard drinks per day, or ≥15 standard drinks per week for men, or ≥8 standard drinks per week for women)
Alcohol or drug abuse in the past year
Blood donation during or within 30 days of the last study visit
Subjects with unstable medical conditions as assessed by the QI
Clinically significant abnormal laboratory results at screening as assessed by the QI
Participation in a clinical research trial within 30 days prior to randomization
Individuals who are cognitively impaired and/or who are unable to give informed consent
Any other condition which in the QI's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose a significant risk to the subject