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 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT03037918
Eligibility Criteria:
Inclusion Criteria:
* Males and females
* Aged 18-30
* Physically active (exercising at least 3 times per week for more than 30 min at a time)
* Non-smoker
* Free from cardiovascular or metabolic disease
* Weight stable for at least 6 months
* Normal body mass index (BMI: 18.5-24.9 kg/m2)\*
* Compliant (i.e. understands and is willing, able and likely to comply with all study requirements)
* Note: If BMI is \>24.9, but body fat % (as measured by bioelectrical impedance analysis) is below 21% in males and 31% in females, then the subject may still be recruited at the PI's discretion.
Exclusion Criteria:
* Using probiotic or prebiotic supplements within the previous 3 months
* Vegetarians and vegans
* Diagnosis of insulin resistance, pre-diabetes or full diabetes
* Underweight (determined as BMI less than 18.5 kg/m2)
* Overweight or obese (determined as BMI greater than 24.9 kg/m2)
* Those on a calorie controlled diet or other dietary restrictions that would prevent them from consuming the probiotic treatment and high fat/high calorie diet.
* Those who are unwilling to restrict their intake of fermented dairy products.
* Those with known or suspected food intolerances, allergies or hypersensitivity
* Women who are known to be pregnant or who are intending to become pregnant over the course of the study.
* Participation in another clinical trial
* Those who have donated blood within 3 months of the screening visit and participants for whom participation in this study would result in having donated more than 1500 ml of blood in the previous 12 months.
* Participants who take any form of regular medication that is known to affect either the gut microbiota and/or insulin sensitivity or who have taken any antibiotics in the previous 3 months.
* Participants who know they would not be available for all the lab visits during the 4-week study period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT03037918
Study Brief:
Protocol Section:
NCT03037918