Mushrooms and their potential health effect on blood cholesterol

Not Applicable

Withdrawn

• Conditions: Hypercholesterolemia; Cardiovascular - Coronary heart disease; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12624000424505
• Lead Sponsor: Commonwealth Scientific and Industrial Research Organisation (CSIRO)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-08
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

INCLUSION CRITERIA:
1.Willing and able to provide written Informed Consent
2.Access to a personal email inbox
3.Male or Female individuals
4.Aged > or equal to 18 & <66 years of age at clinic screening
5.BMI > or equal to 18.5 kg/m2 and <35 kg/m2 at time of clinic screening
6.Low cardiovascular disease (CVD) risk score in individuals aged > or equal to 45 years of <5% estimated 5-year CVD risk determined using the Australian CVD risk calculator (cvdcheck.org.au)
7.Fasting LDL-cholesterol > or equal to 3.0 mmol/L and < or equal to 5 mmol/L confirmed at clinic screening (plasma)
8.Have access to a Coles supermarket
9.Ability to refrigerate mushrooms/vegetables and have the facilities to prepare and cook them

Exclusion Criteria

EXCLUSION CRITERIA:
1.Use of and not prepared to abstain from marine and algae derived omega-3 supplements at high dose (>900 mg/day of docosahexaenoic acid (DHA) / eicosapentaenoic acid (EPA)) or marine and algae derived omega 3 fortified foods that may, in the opinion of the PI or designee, affect lipid concentrations, within the 84 days of Day 0
2.Use of lipid lowering medications (e.g. statins, metformin, fibrates, cholesterol absorption inhibitors, nicotinic acid) or lipid raising medications (eg. Beta blockers, steroids, amiodarone, diuretics) within 28 days of Day 0.
3.Use of and not prepared to abstain from supplements, or foods containing ß-glucan (oats, barley, rye, nutritional yeast, mushrooms other than study mushrooms) or other substances (e.g. psyllium, plant sterol fortified foods and supplements, curcumin, turmeric) that may, in the opinion of the PI or designee, affect lipid concentrations within 14 days of Day 0
4.Previous diagnosis of chronic disease such as CVD, diabetes
(Type I, Type II, and/or Gestational Diabetes), cancer, familial hypercholesterolaemia, kidney disease, liver disease
5.Smoking (i.e., history of smoking within the last six months)
6.Serum triglycerides >4.5mmol/L (LDL-cholesterol concentrations are unreliable in the presence of high triglyceride levels) confirmed at clinic screening (using capillary plasma)
7.Hypertension (blood pressure > or equal to 140/90mmHg)
8.Suspected aversion and/or intolerance to mushrooms
9.Unwilling or unable to maintain usual levels of physical activity or dietary intake for the duration of the study
10.Currently pregnant and/or nursing (lactating), self-reported by the applicant
11.Currently hospitalised or any planned hospitalisations during the study that may affect the applicant’s ability to comply with the study in the opinion of the PI or designee
12.Received an investigational drug within 90 days of Day 0, that in the opinion of the PI or designee may affect the outcome of the study
13.Unable to comply, experience distress with study procedures, or has a medical condition and/or receiving medical treatments (including medications) that in the opinion of the PI or designee, may affect the outcome of the study
14.Travel which may interfere with complying to the study diet guidelines

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ow-density lipoprotein cholesterol (LDL-C)[Serum LDL-C using Beckman Coulter Baseline and end of each intervention period: visits 1 (day 0), 2 (day 28±3, primary timepoint), 3 (day 42±3) and 4 (day 70±3, primary timepoint) post commencement of dietary intervention.]