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:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT04823156
Eligibility Criteria:
Inclusion Criteria:
1. Female sex;
2. Aged 18 to 36 years old;
3. Maximal rate of oxygen uptake of ≥ 35 ml∙kg-1∙min-1;
4. Weight stable (no change in self-reported body mass ≥ 5% over the previous 3 months);
5. BMI between 18 and 30 kg∙m2;
6. Not pregnant.
Exclusion Criteria:
1. Evidence of disordered eating (≥ 20 on the EAT-26);
2. Self-reported change in body mass of ≥ 5% over the previous 3 months;
3. Vitamin D deficient (total 25(OH)D \< 30 nmol∙L-1);
4. Maximal rate of oxygen uptake of \< 35 ml∙kg-1∙min-1;
5. Total body BMD T-score of \< -1;
6. Evidence of menstrual disturbance (oligomenorrhoea: \< 9 menstrual cycles in previous 12 months or amenorrhoea: ≤ 3 menstrual cycles in the previous 12 months);
7. Pregnant;
8. Current smoker, or stopped smoking within the last three months;
9. Taking any medications known to affect bone or calcium metabolism (e.g. treatment for thyroid disorders);
10. Self-declared history of heart, liver or kidney disease, diabetes or thyroid disorder;
11. Self-reported stress fracture or any other bone injuries in the previous 12 months;
12. Anaemia (haemoglobin \<12 g∙/dL-1).
13. Currently using the implant, injection, or the progesterone-only pill ('mini pill').
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
36 Years
Study:
NCT04823156
Study Brief:
Protocol Section:
NCT04823156