Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT06571994
Eligibility Criteria:
Inclusion Criteria:
1. Biological males or, non-pregnant, non-lactating biological females aged 18 to 60 years.
a) For female participants at least one of the following must apply: i) Not of childbearing potential - surgical sterile or postmenopausal (no menses last 12 months and follicle-stimulating hormone (FSH) greater than 40 mIU/mL); ii) Childbearing potential and agrees to practice true abstinence, is in a same-sex relationship or agrees to use effective contraception during the study (either hormonal contraception, intrauterine devices or condom) or has a vasectomised male partner.
2. Body mass index ≥30 kg/m2. If outside this range, eligible at investigator's discretion.
3. Waist circumference ≥102cm in men and ≥88cm in women. If outside this range, eligible at investigator's discretion.
4. Certain medications may be excluded based on investigators discretion.
5. Lives in the Perth Metropolitan Area.
6. Willing to change all they eat, not eat out and not wear makeup for 4 weeks if selected for intervention.
7. Ability to give written informed consent.
8. Proof of immunisation against COVID-19 (SARS-CoV-2), according to WA Health guidelines at time of recruitment.
Exclusion Criteria:
1. Any abnormalities in electrocardiogram (ECG) readings, or as per the Investigator's discretion.
2. History of drug or alcohol abuse in the past 24 months. Alcohol abuse defined as greater than 21 units/week for males, greater than 14 units/week for females.
3. Current regular smoker or e-cigarette use. Social smokers (less than 3 nicotine/tobacco products in the last 3 months) can be included if abstaining for the duration of the study.
4. Currently pregnant or planning pregnancy during the course of the study as assessed by pregnancy testing carried out during screening.
5. Currently on, or within 3 months of discontinuing, glucagon-like peptide-1 agonists or related compounds. If inside this range, eligible at Investigator's discretion.
6. Living in a home that has been renovated in the past 4-weeks.
7. Have known severe food allergies or anaphylaxis to common food allergens. As per the Investigator's discretion.
8. Not suitable for the study for any other reason, as determined by the investigator.
9. Acute infection, surgery, vaccination, or other inflammatory process in the previous 2 weeks. Minor procedures are exempt at investigator's discretion.
10. Evidence of moderate or greater renal impairment at screening, as indicated by an estimated creatinine clearance of less than 60 mL/min using the Cockcroft-Gault equation.
11. Clinically significant abnormal laboratory tests or examination findings, as determined by the investigator, not otherwise mentioned.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06571994
Study Brief:
Protocol Section:
NCT06571994