Amino Acid Bioavailability in Healthy Elderly After Intake of an Oral Nutritional Supplement

Study Overview
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Brief Summary
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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.

Official Title
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Amino Acid Bioavailability in Healthy Elderly After Bolus Intake of a High Whey-protein, Leucine-rich, Low-caloric Oral Nutritional Supplement

Conditions
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Sarcopenia

Intervention / Treatment
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* Dietary Supplement: Bolus ONS A
* Dietary Supplement: Bolus ONS B
* Dietary Supplement: Bolus ONS C
* Dietary Supplement: Bolus ONS D


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bolus ONS intake<br>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. | Dietary Supplement: Bolus ONS A<br>* High-whey protein, leucine-rich, low-caloric ONS in powder format<br>Dietary Supplement: Bolus ONS B<br>* High casein-protein, low-caloric control product (isocaloric to product A)<br>Dietary Supplement: Bolus ONS C<br>* High casein-protein, high-caloric control product.<br>Dietary Supplement: Bolus ONS D<br>* high whey-protein, leucine-rich, high-caloric control product (isocaloric to product C)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioavailability, Amino Acids, Elderly, Supplement