A Follow-up Trial of Proglucamune® in the Treatment of Protective Qi Deficiency, a TCM Condition

NCT03782974 | Completed Results

• 1 other identifier: 201878
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief Summary

This is a follow-up Phase II study of a previously complete pilot trial (Protocol ID: 201875) with the same goal: evaluating the activity of Proglucamune on Protective Qi (PQi) Insufficiency. According to Traditional Chinese Medicine (TCM) principle, Protective Qi 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, Protective Qi 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 Lucidum (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. The data obtained demonstrated a statistically significant effect of Proglucamune on improving PQi in individuals with PQi Insufficiency. The current study is aimed to further determine this effect in a more stringent (placebo-controlled, randomized, and triple-blinded) way.

Conditions

Protective Qi Insufficiency (a Condition Term From TCM)

Keywords

Protective Qi; Immunity

Outcome Measures

Primary Outcomes (2)

• Change in Severity Score of Protective Qi Deficiency

  The severity score of Protective Qi Deficiency in all participants will be assessed at baseline and each follow-up visit by on-site investigators (licensed TCM practitioners). Each health condition relevant to Protective Qi Deficiency(PQD) (i.e., cold frequency, symptoms, and signs) will be scored on a designed scale (with higher number indicating more severe condition/symptom) based on a set of standardized and specified criteria (see uploaded Study Protocol for specifics). The sub-scores are then weighted (cold frequency 25%, symptoms 33.3%, signs: 41.7%) to arrive at a final PQD severity score. This score is on a 1-5 scale, with 5 being the most severe deficiency. The change of the score from baseline, indicating the treatment effect, will be calculated and analyzed by statistical means.

  The participants PQD severity score will be re-evaluted every two weeks for a total of 12 weeks.

• Change of PQD Status as Asessed by Traditional Methods.

  PQD status of each participant at baseline and each follow-up visit will be measured by on-site investigators (licensed TCM practitioners) through qualitative traditional assessment based on TCM practitioners' clinical experience. The status was characterized as non-PQD or PQD. The change of PQD status from baseline, indicating a treatment effect, will be calculated and analyzed by categorical statistics.

  The participants will be followed every two weeks for a total of 12 weeks.

Secondary Outcomes (6)

• Global Health_Physical Health

  The participants will be followed every two weeks for a total of 12 weeks.

• Global Health_Mental Health

  The participants will be followed every two weeks for a total of 12 weeks.

• Saliva sIgA Secretion Rate

  The participants will be followed every 6 weeks during 12 week trial.

• Emotional and Behavioral Dyscontrol - Short Form

  The participants will be followed every two weeks for a total of 12 weeks.

• Emotional Impact

  The participants will be followed every two weeks for a total of 12 weeks.

Study Arms (2)

Proglucamune treatment

EXPERIMENTAL

Participants were treated with 2 tablets of Proglucamune per day (containing 200mg of beta glucan) for a total duration of 8 weeks.

Dietary Supplement: beta glucan

Placebo

PLACEBO COMPARATOR

Participants were treated with 2 tablets of placebo per day (contain no beta glucan) for a total duration of 8 weeks.

Dietary Supplement: beta glucan

Interventions

beta glucan DIETARY_SUPPLEMENT

Following screening and enrollment, participants will be treated with 2 tablets (Proglucamune or placebo) 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).

Placebo; 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 12 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.
• Exhibit an PQi Insufficiency score \> 2 (See Primary Outcome Measure)

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.
• 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 or have scheduled a surgery during the study period.
• 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.
• 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, acetylsalicylic acid), 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)

• Keller SD, Yang M, Treadwell MJ, Werner EM, Hassell KL. Patient reports of health outcome for adults living with sickle cell disease: development and testing of the ASCQ-Me item banks. Health Qual Life Outcomes. 2014 Aug 22;12:125. doi: 10.1186/s12955-014-0125-0.

  PMID: 25146160 BACKGROUND

• Hays RD, Spritzer KL, Thompson WW, Cella D. U.S. General Population Estimate for "Excellent" to "Poor" Self-Rated Health Item. J Gen Intern Med. 2015 Oct;30(10):1511-6. doi: 10.1007/s11606-015-3290-x. Epub 2015 Apr 2.

  PMID: 25832617 BACKGROUND

• Wu JR, Cheng HJ, Shi JP, Yin WD, Wang J, Ou XQ, Chen JL, Bernstein I, Levy M, Maddela R, Sinnott R, Tian JQ. beta -Glucan Improves Protective Qi Status in Adults with Protective Qi Deficiency-A Randomized, Placebo-Controlled, and Double-Blinded Trial. Chin J Integr Med. 2022 May;28(5):394-402. doi: 10.1007/s11655-021-3444-0. Epub 2021 May 8.

  PMID: 33963479 DERIVED

Related Links

• description for Global Health Questionnaire (PROMIS® Scale v1.2.)
• description for Emotional \& Behavioral Dyscontrol Questionnaire (Neuro-QoL)

MeSH Terms

Interventions

beta-Glucans

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates

Limitations and Caveats

Since the treatment (Proglucamune) is a mixture of extract from yeast and whole mushrooms (Reishi and Shiitaki), we cannot completely rule out the possibility that some compounds other than ß-glucan present in Proglucamune may have contributed to the observed effect. This is particularly so given that Reishi, known for boosting Qi in TCM, contains a variety of other biologically active compounds .

Results Point of Contact

• Title: Dr. Jeremy Tian
• Organization: USANA Health Sciences

jeremy.tian@usanainc.com

01-801-954-7658

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants, on-site care-providers and investigators, and the outcome assessors will be informed that this study is placebo controlled, and that each participant has a 50/50 chance of receiving treatment or placebo. The test material will include treatment and placebo, both coated by the same coating. The code will be kept by the sponsor and disclosed after the analyses are completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Individuals with Protective Qi Insufficiency

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 20, 2018
• Study Start: January 6, 2019
• Primary Completion: June 6, 2019
• Study Completion: June 6, 2019
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)