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Trial registered on ANZCTR


Registration number
ACTRN12624000424505
Ethics application status
Approved
Date submitted
13/03/2024
Date registered
8/04/2024
Date last updated
18/08/2024
Date data sharing statement initially provided
8/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Mushrooms and their potential health effect on blood cholesterol
Scientific title
Investigating the effects of mushrooms compared to non-starchy vegetables on low-density lipoprotein cholesterol (LDL-C) in adults with mild hypercholesterolaemia – a randomised controlled cross-over trial
Secondary ID [1] 311717 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 333194 0
Condition category
Condition code
Cardiovascular 329882 329882 0 0
Coronary heart disease
Cardiovascular 330012 330012 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mushroom intervention: 200 g of Agaricus bisporus white button mushrooms (raw weight) per day replacing 200 g of usual vegetable intake for 4 weeks.
Foods and supplements high in beta-glucan or other substances that may affect cholesterol levels will be excluded from the diet and replaced with suitable alternatives (e.g. oats at breakfast could be replaced with cereal flakes or pearl barley could be replaced by brown rice).
At the beginning of the mushroom intervention phase during a ~25 min in-person consultation with a research dietitian/nutritionist, either at the baseline or visit 3, the participant will be provided with tailored advice (based on their usual diet) about how to include the mushrooms into their usual diet. Participants will also be provided with an instruction manual including information about the study design, the diet protocol, purchasing of mushrooms, monitoring of compliance, foods to avoid and alternatives, cooking ideas, recipes and frequently asked questions.
Participants will be provided with a voucher to purchase mushrooms weekly from a local supermarket chain (Coles Supermarket, that have stores spread out across Adelaide). The instruction manual will include clear instructions of where and the type of mushrooms to purchase. Note, mushrooms sold at all Coles stores in Adelaide are supplied by one mushroom producer.
To assess compliance, participants will complete a daily log about their consumption of mushrooms and excluded foods. The information will also be logged via a weekly online survey.
A cross-over study design will be followed. Washout period in-between interventions will be two weeks.
Intervention code [1] 328180 0
Treatment: Other
Intervention code [2] 328251 0
Lifestyle
Comparator / control treatment
Control intervention: 200 g of non-starchy vegetables per day replacing 200 g of normal vegetable intake excluding mushrooms.
Foods and supplements high in beta-glucan or other substances that may affect cholesterol levels will be excluded from the diet and replaced with suitable alternatives (the same alternatives as for the mushroom intervention).
At the beginning of the control intervention phase during a ~25 min in-person consultation with a research dietitian/nutritionist, either at the baseline or visit 3, the participant will be provided with tailored advice (based on their usual diet) about how to include non-starchy vegetables into their usual diet. Participants will also be provided with an instruction manual including information about the study design, the diet protocol, purchasing of non-starchy vegetables including a list of vegetable options, monitoring of compliance, foods to avoid and alternatives, cooking ideas, recipes and frequently asked questions.
Participants will be provided with a voucher to purchase non-starchy vegetables weekly from a local supermarket chain (Coles Supermarket, that have stores spread out across Adelaide). The instruction manual will include clear instructions of where and the type of vegetables to purchase.
To assess compliance, participants will complete a daily log about their consumption of non-starch vegetables and excluded foods. The information will also be logged via a weekly online survey.
A cross-over study design will be followed. Washout period in-between interventions will be two weeks.
Control group
Active

Outcomes
Primary outcome [1] 337652 0
Low-density lipoprotein cholesterol (LDL-C)
Timepoint [1] 337652 0
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.
Secondary outcome [1] 432687 0
Total cholesterol
Timepoint [1] 432687 0
Baseline and end of each intervention period: visits 1 (day 0), 2 (day 28±3), 3 (day 42±3) and 4 (day 70±3) post commencement of dietary intervention
Secondary outcome [2] 432688 0
High-density lipoprotein cholesterol (HDL-C)
Timepoint [2] 432688 0
Baseline and end of each intervention period: visits 1 (day 0), 2 (day 28±3), 3 (day 42±3) and 4 (day 70±3) post commencement of dietary intervention
Secondary outcome [3] 432689 0
Triglycerides
Timepoint [3] 432689 0
Baseline and end of each intervention period: visits 1 (day 0), 2 (day 28±3), 3 (day 42±3) and 4 (day 70±3) post commencement of dietary intervention
Secondary outcome [4] 432690 0
Non-HDL-C
Timepoint [4] 432690 0
Baseline and end of each intervention period: visits 1 (day 0), 2 (day 28±3), 3 (day 42±3) and 4 (day 70±3) post commencement of dietary intervention
Secondary outcome [5] 432691 0
Total cholesterol : HDL-C ratio
Timepoint [5] 432691 0
Baseline and end of each intervention period: visits 1 (day 0), 2 (day 28±3), 3 (day 42±3) and 4 (day 70±3) post commencement of dietary intervention
Secondary outcome [6] 432692 0
Dietary intake
Timepoint [6] 432692 0
Two 24-hour recalls will be completed before commencement of dietary intervention (day -7 - -1); end of 1st intervention phase (days 21-27 post commencement of dietary intervention); end of washout period (days 35-41 post commencement of dietary intervention); end of 2nd intervention phase (days 63-69 post commencement of dietary intervention)
Secondary outcome [7] 432693 0
Body mass index (BMI)
Timepoint [7] 432693 0
Baseline and end of each intervention period: visits 1 (day 0), 2 (day 28±3), 3 (day 42±3) and 4 (day 70±3) post commencement of dietary intervention
Secondary outcome [8] 432694 0
Participant perceptions and experience of the mushroom intervention.
Timepoint [8] 432694 0
End of mushroom intervention period: visits 2 (day 28±3 post commencement of dietary intervention), and 4 (day 70±3 post commencement of dietary intervention)
Secondary outcome [9] 432695 0
Safety outcome: vital signs (blood pressure, heart rate, respiratory rate, temperature)
Timepoint [9] 432695 0
Baseline and end of each intervention period: visits 1 (day 0), 2 (day 28±3), 3 (day 42±3) and 4 (day 70±3) post commencement of dietary intervention
Secondary outcome [10] 432696 0
Safety outcome: Adverse events
Timepoint [10] 432696 0
Throughout the intervention with follow-up at each study visit: visits 2 (day 28±3), 3 (day 42±3) and 4 (day 70±3) post commencement of dietary intervention
Secondary outcome [11] 432697 0
Safety outcome: Concomitant medications
Timepoint [11] 432697 0
Throughout the intervention with follow-up at each study visit: visits 2 (day 28±3), 3 (day 42±3) and 4 (day 70±3) post commencement of dietary intervention,

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 42 participants will provide 80% statistical power at a=0.05 (two-tailed) and account for a dropout rate of 20%, to detect an LDL-C effect size of ~0.25 mmol/L,
Prior to database lock, a final detailed Statistical Analysis Plan (SAP) will be available.
In brief, statistical analysis will be performed using SPSS software. Comparisons between interventions for continues outcome variables will be analysed using linear mixed models for repeated measures. In cases where significant intervention x time interactions are observed post-hoc analyses with Bonferroni adjustments will be conducted. The data will be examined for interaction effects due to the order in which the meals were consumed. A p-value <0.05 will be considered significant.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
8/04/2024
Actual
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
29/11/2024
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 26265 0
CSIRO Nutrition & Health Research Clinic - Adelaide
Recruitment postcode(s) [1] 42234 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 316045 0
Commercial sector/Industry
Name [1] 316045 0
Horticultural Innovation
Country [1] 316045 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Address
Country
Australia
Secondary sponsor category [1] 318318 0
None
Name [1] 318318 0
Address [1] 318318 0
Country [1] 318318 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314867 0
CSIRO Health and Medical Human Research Ethics Committee
Ethics committee address [1] 314867 0
Ethics committee country [1] 314867 0
Australia
Date submitted for ethics approval [1] 314867 0
14/11/2023
Approval date [1] 314867 0
05/02/2024
Ethics approval number [1] 314867 0
2023_068_HREC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132986 0
Prof Welma Stonehouse
Address 132986 0
CSIRO, South Australian Medical Research Institute Building, North Terrace, Adelaide SA 5000
Country 132986 0
Australia
Phone 132986 0
+61 08 83038919
Fax 132986 0
Email 132986 0
welma.stonehouse@csiro.au
Contact person for public queries
Name 132987 0
Brooke Wymond
Address 132987 0
CSIRO, South Australian Medical Research Institute Building, North Terrace, Adelaide SA 5000
Country 132987 0
Australia
Phone 132987 0
+61 08 83038856
Fax 132987 0
Email 132987 0
brooke.wymond@csiro.au
Contact person for scientific queries
Name 132988 0
Welma Stonehouse
Address 132988 0
CSIRO, South Australian Medical Research Institute Building, North Terrace, Adelaide SA 5000
Country 132988 0
Australia
Phone 132988 0
+61 08 83038919
Fax 132988 0
Email 132988 0
welma.stonehouse@csiro.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Following publication, no end date
Available to whom?
Researchers who request access to the data and provide a proposal with sound rationale and methodology and pending Principal Investigator and Human Research Ethics Committee approval.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
CSIRO Data Access Portal (DAP) - access is subject to CSIRO and Human Research Ethics Commitee approval. Access to the portal may be requested by emailing the principal investigator (welma.stonehouse@csiro.au).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21854Analytic code  welma.stonehouse@csiro.au
21855Data dictionary  welma.stonehouse@csiro.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.