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 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT02013466
Eligibility Criteria:
Inclusion Criteria:
* Age 65 years or older
* BMI between 21 and 30 kg/m2
Exclusion Criteria:
* Any condition that may interfere with the definition 'healthy elderly' according to the investigator's judgement.
* Any (history of) gastrointestinal disease that interferes with GI function (e.g. inflammatory bowel disease, gastroparesis, gastrectomy).
* Known allergy to milk and milk products.
* Known galactosaemia.
* Current or recent (within past three months) smoking.
* Known or suspected Diabetes Mellitus.
* Current infection or fever in the last 7 days at the discretion of the physician.
* Use of antibiotics within 3 weeks of study entry.
* Current use of corticosteroids or hormones.
* Current use of antacids or any medication influencing gastric acid production.
* Requirement for any nutritional support.
* Unplanned body weight loss \> 5% in the past 3-6 months.
* Adherence to any specific diet (e.g. weight loss, vegetarian).
* Use of protein containing or amino acid containing nutritional supplements within one week of study entry.
* Alcohol or drug abuse.
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
* Participation in any other study with investigational products concomitantly or within 4 weeks of study entry.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT02013466
Study Brief:
Protocol Section:
NCT02013466