Anti-hypertensive Effect of Mycelia of Antrodia Cinnamomea

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: AC mycelia

• Registration Number: NCT02532699
• Lead Sponsor: Chung Shan Medical University

Brief Summary

This the first report undertaken to assess the effect of supplementation with oral gamma-aminobutyric acid (GABA), adenosine and antrosterol-containing AC mycelia on blood pressure among people with mild hypertension. Overall, AC mycelia consumption for 8 weeks could successfully reduce mean diastolic and systolic BP through the suppression of PRA that is linked to downstream suppresion of angiotensin II formation, which further decreases the sympathetic outflow that leads to hypertension. In addition to blood pressure lowering properties, AC mycelia also has beneficial effect in reducing oxidative stress, significantly. No adverse events were noted, suggesting that AC mycelia deserve its consideration as a candidate for safe alternative treatment to conventional anti-hypertensive medications.

Detailed Description

This the first report undertaken to assess the effect of supplementation with oral gamma-aminobutyric acid (GABA), adenosine and antrosterol-containing AC mycelia on blood pressure among people with mild hypertension. Forty-one subjects with systolic blood pressure (SBP) between 130 and 179 mm Hg and/or diastolic blood pressure (DBP) between 85 and 109 mm Hg were randomized to receive either AC mycelia or starch placebo for 8 weeks, and had follow-up observation for an additional 2 weeks. SBP in the subjects given GABA, adenosine and antrosterol-rich AC mycelia significantly decreased compared to those who received the placebo (p\<0.05). DBP also decreased after the intake of AC mycelia. Compared to the placebo, AC mycelia significantly reduced plasma renin activity by a maximum of 25 % and 36 % on week 8. This suppression suggested that AC mycelia is a potent inhibitor of renin, and its bioavailability is sufficient to produce BP reduction after a short term of oral administration. Neither adverse events nor abnormal laboratory findings were noted throughout the study period, suggesting that GABA, adenosine and antrosterol-rich AC mycelia significantly decreased borderline hypertension, which may support its consideration as a safe alternative treatment compared to conventional anti-hypertensive medications.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-01
• Study Completion: 2012-07
• Status Verified: 2015-08
• Study First Submitted: 2015-08-14
• Study First Submitted QC: 2015-08-23
• Last Update Submitted: 2015-08-23
• Study First Posted: 2015-08-26
• Last Update Posted: 2015-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Eligible subjects were untreated hypertensive men or women aged between 20 and 80 years old with SBP between 130 and 179 mmHg and/or DBP between 85 and 109 mmHg as measured in a sitting position

Exclusion Criteria

• Subjects were excluded if they had a history of major cardiovascular disease, severe liver dysfunction, insulin-dependent diabetes mellitus or stroke. They were also excluded if they routinely consumed alcohol, were pregnant or unable to comprehend study instructions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects receive three capsules per day containing starch placebo of similar appearance.
AC mycelia	AC mycelia	Subjects receive three capsules per day containing either 420 mg of AC mycelia.

Primary Outcome Measures

Name	Time	Method
AC anti-hypertensive measure blood pressure (SBP and DBP )	10 weeks	"Blood pressure" to "Number of pressure with SBP and DBP,

Secondary Outcome Measures

Name	Time	Method
Blood biochemical values (Liver function)	10 weeks	values of liver function with AST and ALT