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Completed

NCT Number: NCT02532699

Anti-hypertensive Effect of Mycelia of Antrodia Cinnamomea

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AC mycelia

Dietary Supplement

An 8 week double-blinded randomized placebo-controlled parallel study with 2 week follow-up period was performed in mild hypertension subjects. Consenting eligible subjects were receive three capsules per day containing either 420 mg of AC mycelia of similar appearance for 8 weeks. The subjects were required to visit at baseline, every two weeks during the intervention period (8 weeks), and at follow-up 2 weeks after treatment had ended. During each study visit, systolic and diastolic BPs were recorded, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls.

Other names: niu-chang-chih

Placebo

Dietary Supplement

An 8 week double-blinded randomized placebo-controlled parallel study with 2 week follow-up period was performed in mild hypertension subjects. Consenting eligible subjects were receive three capsules per day containing 420 mg starch placebo of similar appearance for 8 weeks. The subjects were required to visit at baseline, every two weeks during the intervention period (8 weeks), and at follow-up 2 weeks after treatment had ended. During each study visit, systolic and diastolic BPs were recorded, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls.

Primary outcomes

  1. AC anti-hypertensive measure blood pressure (SBP and DBP )

    Time frame: 10 weeks

    "Blood pressure" to "Number of pressure with SBP and DBP,

Secondary outcomes

  1. Blood biochemical values (Liver function)

    Time frame: 10 weeks

    values of liver function with AST and ALT

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

Anti-hypertensive Effect of Fermented Mycelia of Antrodia Cinnamomea Among Mild Hypertensive Subjects in a Double-blinded Randomized Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 26, 2015
Registry last updated
Aug 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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