Anti-hypertensive Effect of Mycelia of Antrodia Cinnamomea

NCT02532699 | Completed DMC

• 2 other identifiers: CS11043E099N0115-MY2
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Keywords

Antrodia cinnamomea mycelia; blood pressure; adenosine; antrosterol; clinical trial; gamma-aminobutyric acid

Outcome Measures

Primary Outcomes (1)

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

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

  10 weeks

Secondary Outcomes (1)

• Blood biochemical values (Liver function)

  10 weeks

Study Arms (2)

AC mycelia

ACTIVE COMPARATOR

Subjects receive three capsules per day containing either 420 mg of AC mycelia.

Dietary Supplement: AC mycelia

Placebo

PLACEBO COMPARATOR

Subjects receive three capsules per day containing starch placebo of similar appearance.

Dietary Supplement: Placebo

Interventions

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.

Also known as: niu-chang-chih

AC mycelia

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.

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Related Publications (1)

• 1. Geethangili, M.; Tzeng, Y.M. Review of pharmacological effects of antrodia camphorata and its bioactive compounds. Evidence-based complementary and alternative medicine : eCAM 2011, 2011, 212641. 2. Liu, D.Z.; Liang, Y.C.; Lin, S.Y.; Lin, Y.S.; Wu, W.C.; Hou, W.C.; Su, C.H. Antihypertensive activities of a solid-state culture of taiwanofungus camphoratus (chang-chih) in spontaneously hypertensive rats. Bioscience, biotechnology, and biochemistry 2007, 71, 23-30. 3. Jong-Wook Shin, S.-I.L.; Kim, S.-D. Effect of acetic acid fermented juice prepared using submerged culture media of antrodia camphorata mycelium on blood glucose and lipid profiles of rats in which diabetes was induced with streptozotocin. Korean J. Food Preserv. 2008, 15, 725-730.

  BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• You-Cheng Mr Shen, Ph.D.

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: School of Health Diet and Industry Managment

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 26, 2015
• Study Start: June 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 26, 2015

Record last verified: 2015-08