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 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT02465151
Eligibility Criteria:
Inclusion Criteria:
* Aged between 7-12 years of age
* Healthy and recreationally physically active (obtaining a 3- day average moderate/vigorous physical activity of at least 30 min/day)
* Body mass at ≥10th percentile for 7 year olds and ≤85th percentile for 12 year olds. Values based upon 2000 CDC Growth Charts for the United States
* Having obtained his/her informed assent
* Having obtained his/her consent from parent or legal guardian
* Being able to communicate in local language
* Have a habitual daily protein consumption of between 1.6 g/kg and 2.4 g/kg/bw
Exclusion Criteria:
* Self-report on regular medication impacting the metabolism, such as corticoids, hormone (e.g thyroid, adrenal) treatment, or medication against diabetes or against hypercholesterolemia or hypertriglyceridemia
* Self-reported history of metabolic, hepatic or renal disease
* Self-reported allergy to milk proteins (e.g., whey or casein) or intolerance to any food ingredients to be used in the study products and meals
* Within 1.5 years of estimated age of peak height velocity (PHV)
* Special diet or weight loss program (e.g Atkins diet)
* Consuming breakfast containing more than 21g of protein on each day of the 3-d screening period
* Subject who cannot be expected to comply with the study procedures, including unwillingness to consume study product and meals
* Currently participating or having participated in another nutritional-clinical trial during the last 2 months prior to the beginning of this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
10 Years
Study:
NCT02465151
Study Brief:
Protocol Section:
NCT02465151