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In this study healthy older adults are requested to consume 4 different high-protein nutritional supplements. Each subject will visit the site 4 times and at every visit they will consume 1 of the 4 products after which a series of blood samples will be taken. The blood samples will be analyzed for amino acid bioavailability in the blood up to 4 hours after consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bolus ONS intake | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bolus ONS A | Dietary Supplement | High-whey protein, leucine-rich, low-caloric ONS in powder format |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome parameter in this study is the Maximum serum leucine concentration (Leumax) [micromol/L]. | Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum leucine incremental area under the curve (iAUC) [micromol/L*min]. | Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits) | |
| Time to reach half the serum leucine iAUC (t½) [minutes]. | Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ampha | Nijmegen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25790724 | Derived | 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. |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Bolus ONS B | Dietary Supplement | High casein-protein, low-caloric control product (isocaloric to product A) |
|
| Bolus ONS C | Dietary Supplement | High casein-protein, high-caloric control product. |
|
| Bolus ONS D | Dietary Supplement | high whey-protein, leucine-rich, high-caloric control product (isocaloric to product C) |
|
| Maximum serum essential amino acid concentration (EAAmax) [micromol/L] | Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits) |
| Maximum serum amino acid concentration (AAmax) [mmol/L] | Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits) |
| Maximum serum insulin concentration [micromol/L]. | Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits) |
| Serum insulin iAUC [micromol/L*min] | Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits) |
| Maximum serum glucose concentration [mmol/L] | Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits) |
| Serum glucose iAUC [mmol/L*min] | Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits) |
| Adverse events and (Gastro-Intestinal) tolerance questionnaire. | During the study and until one week after completion of the study |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |