An Evaluation of Proglucamune in the Treatment of Protective Qi Insufficiency

NCT03829228 | Completed Results

• 1 other identifier: 201875
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

According to Traditional Chinese Medicine (TCM) principle, Protective Qi (PQi) is a one specific concept of Qi that provides the vital energy of the body. It works primarily on the body surface as a defensive barrier. In this context, PQi is analogous to anatomical barriers of the innate immune system located for example, at the skin surface and the mucosal surfaces of the respiratory and digestive tract. Individuals with PQi Insufficiency are predisposed to frequent cold and other symptoms caused by invasion of external pathogens ("Wai Xie" or "external evil" in TCM). ß-glucan is a polysaccharide that activates macrophage (Dectin-1) and neutrophil (CR3) receptors, and therefore enhances immune defense at digestive and respiratory mucosa. Clinical trials have shown its immune activity such as preventing upper respiratory tract infection (URTI) and Traveler's diarrhea. Notably, ß-glucan is a component of Ganoderma Luciderm (or Reishi / Lingzhi), one TCM ingredient well-known for improving Qi. Based on this connection, investigators hypothesized that ß-glucan is the active ingredient in Reishi that at least partially accounts for Reishi's activity on Qi. To test our hypothesis, investigators have conducted an uncontrolled pilot trial that investigated the effect of a commercially available, high ß-glucan containing product, Proglucamune®, on PQi status. Proglucamune contains ß-glucan from three different natural sources: Reishi mushroom, Shiitaki mushroom, and Bakers' yeast, each providing ß-glucan that differs slightly in their molecular structure. Through this pilot investigators sought to obtain an estimate of the effect size of Proglucamune on PQi that would allow us, via statistical methods, to estimate the necessary sample size for more definitive future trials.

Conditions

Protective Qi Insufficiency

Keywords

Protective Qi; Immunity

Outcome Measures

Primary Outcomes (2)

• Change of Protective Qi Score (PQS) Determined by a Standardized Assessment

  Protective Qi of each participant at baseline and each follow-up visit will be measured by an on-site investigator (licensed TCM practitioners) through a standardized quantitative assessment. The evaluation includes 3 health conditions relevant to PQD (cold frequency, symptoms, and signs). Each condition will be scored on a 1-10 scale based on a set of standardized criteria. The sub-scores will be weighted to arrive at a final PQS. So this PQS will be on a 1-10 scale, with 10 being the most healthy state. The change of the PQS from baseline, indicating the treatment effect, will be calculated and analyzed by statistical means.

  The change of PQS was obtained by assessment of PQS at each follow-up visit from the baseline (start date). The follow-up visit was conducted every two weeks throughout the study, i.e., on the 14th, 28th, 42nd, and 56th day from the baseline.

• Change of Protective Qi (PQi) Status Determined by Traditional TCM Assessment

  PQi of each participant at baseline and each follow-up visit was measured by on-site investigators (licensed TCM practitioners) through the traditional TCM assessment, which was diagnosed based on investigators' experience. The evaluation includes 3 health conditions relevant to Protective Qi Deficiency (cold history, symptoms, and signs) but was neither standardized nor quantitative. PQi status was characterized as non-PQD (i.e., healthy condition, no PQD detected) or PQD (i.e., unhealthy condition). The change of the PQi status from baseline, indicating the treatment effect, was analyzed by categorical statistic.

  PQi status was determined at the baseline (start date) and each follow-up visit. The follow-up visit was conducted every two weeks throughout the study, i.e., on the 14th, 28th, 42nd, and 56th day from the baseline.

Secondary Outcomes (2)

• Change of Generic Qi Score (GQS) Determined by a Standardized Assessment

  The change of GQS was obtained by deduction of GQS at each follow-up visit from the baseline (start date). The follow-up visit was conducted every two weeks throughout the study, i.e., on the 14th, 28th, 42nd, and 56th day from the baseline.

• Change of Generic Qi (GQi) Status Determined by Traditional TCM Assessment

  GQi was determined at the baseline (start date) and each follow-up visit. The follow-up visit was conducted every two weeks throughout the study, i.e., on the 14th, 28th, 42nd, and 56th day from the baseline.

Study Arms (1)

Proglucamune treatment

EXPERIMENTAL

Participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks.

Dietary Supplement: Proglucamune

Interventions

Proglucamune DIETARY_SUPPLEMENT

Following screening and enrollment, participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks. Each Proglucamune tablet contained \~100 mg ß-glucan derived from Baker's Yeast extract (Saccharomyces cerevisiae, cell wall), Reishi mushroom powder (Ganoderma lucidum), and Shitake mushroom powder (Lentinula edodes).

Proglucamune treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or females aged 18 to 65 years (inclusive) without regard to race or ethnic background
• Provide a signed Informed Consent prior to entry in the study.
• Willing to follow all study instructions and consume the assigned investigational product for 8 weeks.
• Not currently taking a beta-glucan containing supplement or any other supplement that might interfere with the study design.
• Ability to swallow tablets and pills.
• Diagnosed as having Qi deficiency based on the following criteria:
• exhibit a history of susceptibility to cold\* (\* as defined in Traditional Chinese Medicine, TCM)
• exhibit a shortness of breath
• exhibit a lack of energy or excessive fatigue
• susceptible to spontaneous perspiration
• exhibit a corpulent tongue with or without white fur
• unwillingness to speak
• weak or powerless pulse
• pale complexion

You may not qualify if:

• Persons diagnosed by TCM as having medical conditions other than low Qi.
• Significant acute or chronic illness or other medical conditions that will prevent or interfere with giving an informed consent, or with participation in the study.
• Persons with insulin-dependent and orally controlled diabetes will also be excluded from the study.
• Scheduling difficulties or lack of transportation that will prevent or interfere with their ability to attend all of the necessary study visits.
• Persons medically diagnosed with depression or anxiety disorders.
• Persons with a history of alcohol abuse or other substance abuse within the previous 2 years.
• Females who are attempting to become pregnant, pregnant, lactating or who have given birth within 1 year.
• Persons who have had a medical surgery in the past 4 weeks.
• Persons currently enrolled in a clinical trial, or who have completed a clinical trial within the last 4 weeks.
• Allergies to mushrooms or other fungi.
• Significant problems with constipation or diarrhea.
• Persons exhibiting symptoms of cold\* (\*as defined by TCM) within the past 7 days.
• A lifestyle or schedule incompatible with the study protocol.
• Persons who are allergic to yeast products, have autoimmune disease/an immune disorder, or take antidepressants, blood thinners (anticoagulants), or immunosuppressant medication

Sponsors & Collaborators

• USANA Health Sciences: lead
• Elegant And Olive Health Clinic, Canada: collaborator

Study Sites (1)

Elegant And Olive Health Clinic

Markham, Ontario, L3R 5V6, Canada

Location

Related Publications (3)

• Chan GC, Chan WK, Sze DM. The effects of beta-glucan on human immune and cancer cells. J Hematol Oncol. 2009 Jun 10;2:25. doi: 10.1186/1756-8722-2-25.

  PMID: 19515245 BACKGROUND

• Bashir KMI, Choi JS. Clinical and Physiological Perspectives of beta-Glucans: The Past, Present, and Future. Int J Mol Sci. 2017 Sep 5;18(9):1906. doi: 10.3390/ijms18091906.

  PMID: 28872611 BACKGROUND

• Levy M, Wu JR, Shi JP, Cheng HJ, Qu XQ, Bernstein I, Sinnott R, Tian JQ. Proof-of-Concept and Feasibility Study to Evaluate the Effect of beta-Glucan on Protective Qi Deficiency in Adults. Chin J Integr Med. 2021 Sep;27(9):666-673. doi: 10.1007/s11655-020-3430-y. Epub 2020 Aug 19.

  PMID: 32820452 DERIVED

Limitations and Caveats

Study limitations: First, this was not a randomized, placebo-controlled trial, so the observed effect size likely was inflated by uncontrolled confounders. Second, most participants were receptive to the healing effects of TCM, which may have lead to an overestimate of treatment effect. Lastly, the clinical trial started when flu season had passed its peak. This may have decreased the chance of subjects catching the flu and thereby have led to improved PQi independent of Proglucamune treatment.

Results Point of Contact

• Title: Dr. Junqiang Tian
• Organization: USANA Health Science

jeremy.tian@usanainc.com

8019547462

Study Officials

• Ira Bernstein, MD

  Department of Family and Community Medicine, Humber River Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Given the small sample size in this pilot study and the potential drop-out rate, we did not include a placebo group to control for the placebo effect. Nonetheless, we implemented a "deceptive" double-blinding design, i.e., all on-site care-providers and investigators and all participants were told that this study was placebo controlled, and that each participant had a 50/50 chance of receiving treatment or placebo. This masking helps decreasing the expectation bias from the participants that confound the study result.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects with Protective Qi Insufficiency

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: February 4, 2019
• Study Start: March 18, 2018
• Primary Completion: June 3, 2018
• Study Completion: June 3, 2018
• Last Updated: October 27, 2021
• Results First Posted: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)