Clinical trial to analyze the effects of oral intake of Phellinus linteus (sanghuang) extract on immune function: a study protocol for a randomized, double-blind controlled trial

Abstract Background As the population of Korea ages, interest in healthcare has increased. In particular, there is an increasing demand for immune-function improvement to prevent infectious diseases. Phellinus linteus (PL) has previously been shown to exert immune-enhancing and anticancer effects. W...

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Autores principales:	Yong Ho Ku, Hyun Lee, Hwa Yeon Ryu, Jae Hui Kang
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Immune function Phellinus linteus Randomized controlled trial Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/5d775dbe1cf04c2ab17c352438f03598
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spelling	oai:doaj.org-article:5d775dbe1cf04c2ab17c352438f035982021-11-28T12:28:47ZClinical trial to analyze the effects of oral intake of Phellinus linteus (sanghuang) extract on immune function: a study protocol for a randomized, double-blind controlled trial10.1186/s13063-021-05740-51745-6215https://doaj.org/article/5d775dbe1cf04c2ab17c352438f035982021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05740-5https://doaj.org/toc/1745-6215Abstract Background As the population of Korea ages, interest in healthcare has increased. In particular, there is an increasing demand for immune-function improvement to prevent infectious diseases. Phellinus linteus (PL) has previously been shown to exert immune-enhancing and anticancer effects. We aim to evaluate whether PL mycelium extract, cultured from the PL KCTC0399BP strain, can increase immune function, as measured using blood-test indicators. This clinical trial protocol is designed as the main trial and is based on the results of a pilot study. Methods This clinical trial is a randomized, double-blinded, placebo-controlled trial. Ninety-eight participants are enrolled and randomly divided into two groups: the experimental group (PL 1000 mg) and the control group (placebo). Participants are administered with experimental food or placebo for eight weeks. Blood tests are performed before trial initiation and 8 weeks later, at trial completion. Laboratory evaluation items are as follows: natural killer cell activity, tumor necrosis factor-α, interferon-γ, interleukin (IL)-1β, IL-2, IL-6, IL-12, immunoglobulin (Ig)G1, IgG2, and IgM. We will mainly use the full analysis dataset to statistically analyze the effectiveness of the treatment. Discussion This study evaluates the effects of PL extract on immune function and will contribute to knowledge on the value of PL as an immune-function–boosting functional food. Trial registration Clinical Research Information Service (CRIS) of Korea CRIS-KCT0005460 . Registered on 12 October 2020Yong Ho KuHyun LeeHwa Yeon RyuJae Hui KangBMCarticleImmune functionPhellinus linteusRandomized controlled trialMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-7 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Immune function Phellinus linteus Randomized controlled trial Medicine (General) R5-920
spellingShingle	Immune function Phellinus linteus Randomized controlled trial Medicine (General) R5-920 Yong Ho Ku Hyun Lee Hwa Yeon Ryu Jae Hui Kang Clinical trial to analyze the effects of oral intake of Phellinus linteus (sanghuang) extract on immune function: a study protocol for a randomized, double-blind controlled trial
description	Abstract Background As the population of Korea ages, interest in healthcare has increased. In particular, there is an increasing demand for immune-function improvement to prevent infectious diseases. Phellinus linteus (PL) has previously been shown to exert immune-enhancing and anticancer effects. We aim to evaluate whether PL mycelium extract, cultured from the PL KCTC0399BP strain, can increase immune function, as measured using blood-test indicators. This clinical trial protocol is designed as the main trial and is based on the results of a pilot study. Methods This clinical trial is a randomized, double-blinded, placebo-controlled trial. Ninety-eight participants are enrolled and randomly divided into two groups: the experimental group (PL 1000 mg) and the control group (placebo). Participants are administered with experimental food or placebo for eight weeks. Blood tests are performed before trial initiation and 8 weeks later, at trial completion. Laboratory evaluation items are as follows: natural killer cell activity, tumor necrosis factor-α, interferon-γ, interleukin (IL)-1β, IL-2, IL-6, IL-12, immunoglobulin (Ig)G1, IgG2, and IgM. We will mainly use the full analysis dataset to statistically analyze the effectiveness of the treatment. Discussion This study evaluates the effects of PL extract on immune function and will contribute to knowledge on the value of PL as an immune-function–boosting functional food. Trial registration Clinical Research Information Service (CRIS) of Korea CRIS-KCT0005460 . Registered on 12 October 2020
format	article
author	Yong Ho Ku Hyun Lee Hwa Yeon Ryu Jae Hui Kang
author_facet	Yong Ho Ku Hyun Lee Hwa Yeon Ryu Jae Hui Kang
author_sort	Yong Ho Ku
title	Clinical trial to analyze the effects of oral intake of Phellinus linteus (sanghuang) extract on immune function: a study protocol for a randomized, double-blind controlled trial
title_short	Clinical trial to analyze the effects of oral intake of Phellinus linteus (sanghuang) extract on immune function: a study protocol for a randomized, double-blind controlled trial
title_full	Clinical trial to analyze the effects of oral intake of Phellinus linteus (sanghuang) extract on immune function: a study protocol for a randomized, double-blind controlled trial
title_fullStr	Clinical trial to analyze the effects of oral intake of Phellinus linteus (sanghuang) extract on immune function: a study protocol for a randomized, double-blind controlled trial
title_full_unstemmed	Clinical trial to analyze the effects of oral intake of Phellinus linteus (sanghuang) extract on immune function: a study protocol for a randomized, double-blind controlled trial
title_sort	clinical trial to analyze the effects of oral intake of phellinus linteus (sanghuang) extract on immune function: a study protocol for a randomized, double-blind controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/5d775dbe1cf04c2ab17c352438f03598
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Clinical trial to analyze the effects of oral intake of Phellinus linteus (sanghuang) extract on immune function: a study protocol for a randomized, double-blind controlled trial

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