Week | Visits and activities |
---|---|
Prior to starting the study | Patients who meet eligibility criteria will be asked to read and sign the consent form |
Week 1 | Patients will be instructed on writing the food and physical activity records and procedures for collection of stool samples. They will be asked not to take any other dietary supplementation or probiotics and not to change their medication and/or lifestyle while in the study and to inform the researchers if they are prescribed oral antibiotics at any time during the study |
Week 2 | Stool samples, food record and physical activity record will be collected. Weight, height, waist and hip circumferences, and blood pressure will be measured. Biochemical tests will be performed. The supplement will be delivered |
Week 3, 5, 7, 9 | Contact with the participants and effectiveness or adverse event will be recorded. |
Week 12 | Food record and physical activity record will be collected. Weight, height, waist and hip circumferences, and blood pressure will be measured. Biochemical tests will be performed. The supplement will be delivered |
Week 14, 16, 18, 20 | Contact with the participants and effectiveness/adverse event will be recorded |
Week 24 | Stool samples, food record and physical activity record will be collected. Weight, height, waist and hip circumferences, and blood pressure will be measured. Biochemical tests will be performed |
Week 48, 72 | Food record and physical activity record will be collected. Weight, height, waist and hip circumferences, and blood pressure will be measured. Biochemical tests will be performed |