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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT04399460
Eligibility Criteria:
Inclusion Criteria:
* BMI: ≥ 27 and ≤ 34.9 kg/m2
* Fasting serum glucose: ≤ 7 mmol/L
* Low ≤1 serving of dairy consumption
* Waist circumference \>88cm (women) and \>102cm (men)
* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
* Willing to maintain current dietary supplement use throughout the trial. On test days, participant agrees not to take any dietary supplements until dismissal from the study. Failure to comply will result in a rescheduled test visit.
* Willing to abstain from alcohol consumption for 24 h prior to all test visits.
* Willing to avoid vigorous physical activity for 24 h prior to all test visits.
* Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator
Exclusion Criteria:
* Fasting blood glucose \> 7 mmol/L
* Triglycerides ≥ 2.3 mmol/L
* Smoking tobacco products and marijuana
* Thyroid problems
* Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease.
* Presence of gastrointestinal disorder or surgeries within the past year.
* Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgement.
* Known to be pregnant or lactating, or planning on becoming pregnant in the next 12 months.
* Irregular menstrual cycles (i.e. frequent missed cycles), menopausal or post- menopausal
* Unwillingness or inability to comply with the experimental procedures
* Known intolerance, sensitivity or allergy to dairy products
* Consumption of protein powders/protein supplements
* Extreme dietary habits
* Uncontrolled hypertension as defined by the average blood pressure measured at screening.
* Weight gain or loss of at least 10 lbs in previous three months, and history of childhood overweight or obesity
* Excessive alcohol intake
* Restrained Eaters
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
50 Years
Study:
NCT04399460
Study Brief:
Protocol Section:
NCT04399460