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 @ 1:35 PM
Ignite Modification Date:
2025-12-24 @ 1:35 PM
NCT ID:
NCT03508895
Eligibility Criteria:
Inclusion Criteria:
* BMI: 18.5-40 kg/m2
* Systolic blood pressure between 130-160 mmHg
* Diastolic blood pressure ≤ 110 mmHg
* Ability and willingness to give informed consent to participate in the trial
* Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
* Willingness to fast 10-12 hours before blood samples and abstain from alcohol two days prior to blood sampling and BP measurement and abstain from coffee and physical exercise at least 14 and 4 hours before measurement respectively
* Negative pregnancy test for women with child-bearing potential
Exclusion Criteria:
* Unable to speak/read in English
* Active cardiovascular disease including stroke, congestive heart failure, myocardial infarction, unstable angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, temporal ischemic attacks, secondary hypertension, type 1 or type 2 diabetes, anemia, abnormal electrolytes, proteinuria, and abnormal liver, kidney or thyroid function
* History of cancer or malignancy in the last 5 years, or any metabolic disease, gastrointestinal disorder or other clinically significant disease/disorder which could interfere with the results of the study or the safety of the participant
* Taking lipid or blood pressure lowering medications or any type of supplements for less than 3 months (Note: all medications or supplements will be permitted if they are on a stable dose for more than 3 months before the start of the study)
* Smokers, tobacco/snuff/nicotine users, recreational drug users
* Consuming more than 14 alcoholic beverages a week
* Any dietary restrictions preventing from consuming the trial treatments
* Weight gain or loss greater than 5 kg in the past three months
* Exercising \> 15 miles/wk or 4,000 kcal/wk
* Known to be pregnant or breast-feeding or planning on becoming pregnant during the trial period
* Having clinically significant biochemistry defined as: Sodium: \<134 mmol/l, \>148 mmol/l; fasting glucose: \> 6.1 mmol/L; LDL-C ≥4.9 mmol/L or any other clinically significant abnormality in hematology and/or biochemistry at the investigator's discretion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03508895
Study Brief:
Protocol Section:
NCT03508895