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 @ 12:31 PM
Ignite Modification Date:
2025-12-24 @ 12:31 PM
NCT ID:
NCT03948061
Eligibility Criteria:
Inclusion Criteria:
* Men aged 20 - 65 years
* Post-menopausal women aged 45 - 65 years
* Body Mass Index ≥25 and \<40 kg/m2
* Systolic blood pressure \>120 and \<140 mmHg or diastolic blood pressure \>80 and \<90 mmHg
Exclusion Criteria:
* Diagnosed metabolic disorder
* Diabetes mellitus
* Thyroid disease
* Cardiovascular disease
* Poly-cystic ovary syndrome
* Vasoconstrictive diseases (e.g. Raynaud's phenomenon or Raynaud's disease)
* Digestive disorder (e.g. Crohn's, irritable bowel syndrome, colitis)
* History of gastrointestinal surgery affecting digestion and/or absorption
* Use of medications for hypertension, hyperlipidemia, glycemic control, or weight loss
* Use of medications such as steroids, statins, or non-steroidal anti-inflammatory agents
* Routine use of over-the-counter medications
* Weight change \>5% in the past 6 months
* Performing exercise greater than 60 minutes/day
* Presence of a pacemaker or other internal electronic device controlling rhythm or pacing of heart excludes participant from MindWare procedure
* Presence of atrial fibrillation or other arrhythmia excludes participant from MindWare procedure
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT03948061
Study Brief:
Protocol Section:
NCT03948061