Amino Acid Bioavailability in Healthy Elderly After Intake of an Oral Nutritional Supplement
NCT ID: NCT02013466
Last Updated: 2013-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2008-10-31
2009-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bolus ONS intake
Bolus ONS A Bolus ONS B Bolus ONS C Bolus ONS D ONS = oral nutritional supplement 4-way cross-over design: Determination of the product order is based on a Latin square design. 3 Latin squares (4x4) are used, resulting in 12 unique product orders. Subjects receive a randomisation number corresponding with 1 of the 12 product orders. Study product labels will contain randomisation number and appropriate visit number.
Bolus ONS A
High-whey protein, leucine-rich, low-caloric ONS in powder format
Bolus ONS B
High casein-protein, low-caloric control product (isocaloric to product A)
Bolus ONS C
High casein-protein, high-caloric control product.
Bolus ONS D
high whey-protein, leucine-rich, high-caloric control product (isocaloric to product C)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bolus ONS A
High-whey protein, leucine-rich, low-caloric ONS in powder format
Bolus ONS B
High casein-protein, low-caloric control product (isocaloric to product A)
Bolus ONS C
High casein-protein, high-caloric control product.
Bolus ONS D
high whey-protein, leucine-rich, high-caloric control product (isocaloric to product C)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI between 21 and 30 kg/m2
Exclusion Criteria
* 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.
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nutricia Research
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ampha
Nijmegen, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Luiking YC, Abrahamse E, Ludwig T, Boirie Y, Verlaan S. Protein type and caloric density of protein supplements modulate postprandial amino acid profile through changes in gastrointestinal behaviour: A randomized trial. Clin Nutr. 2016 Feb;35(1):48-58. doi: 10.1016/j.clnu.2015.02.013. Epub 2015 Mar 5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Sip.1.C/B
Identifier Type: -
Identifier Source: org_study_id