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

Primary Purpose

Sarcopenia

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Bolus ONS A
Bolus ONS B
Bolus ONS C
Bolus ONS D
Sponsored by
Nutricia Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sarcopenia focused on measuring Bioavailability, Amino Acids, Elderly, Supplement

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ampha

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Bolus ONS intake

Arm Description

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.

Outcomes

Primary Outcome Measures

The primary outcome parameter in this study is the Maximum serum leucine concentration (Leumax) [micromol/L].

Secondary Outcome Measures

Serum leucine incremental area under the curve (iAUC) [micromol/L*min].
Time to reach half the serum leucine iAUC (t½) [minutes].
Maximum serum essential amino acid concentration (EAAmax) [micromol/L]
Maximum serum amino acid concentration (AAmax) [mmol/L]
Maximum serum insulin concentration [micromol/L].
Serum insulin iAUC [micromol/L*min]
Maximum serum glucose concentration [mmol/L]
Serum glucose iAUC [mmol/L*min]
Adverse events and (Gastro-Intestinal) tolerance questionnaire.

Full Information

First Posted
December 2, 2013
Last Updated
December 11, 2013
Sponsor
Nutricia Research
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1. Study Identification

Unique Protocol Identification Number
NCT02013466
Brief Title
Amino Acid Bioavailability in Healthy Elderly After Intake of an Oral Nutritional Supplement
Acronym
ArenA
Official Title
Amino Acid Bioavailability in Healthy Elderly After Bolus Intake of a High Whey-protein, Leucine-rich, Low-caloric Oral Nutritional Supplement
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nutricia Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Bioavailability, Amino Acids, Elderly, Supplement

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bolus ONS intake
Arm Type
Other
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bolus ONS A
Intervention Description
High-whey protein, leucine-rich, low-caloric ONS in powder format
Intervention Type
Dietary Supplement
Intervention Name(s)
Bolus ONS B
Intervention Description
High casein-protein, low-caloric control product (isocaloric to product A)
Intervention Type
Dietary Supplement
Intervention Name(s)
Bolus ONS C
Intervention Description
High casein-protein, high-caloric control product.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bolus ONS D
Intervention Description
high whey-protein, leucine-rich, high-caloric control product (isocaloric to product C)
Primary Outcome Measure Information:
Title
The primary outcome parameter in this study is the Maximum serum leucine concentration (Leumax) [micromol/L].
Time Frame
Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Secondary Outcome Measure Information:
Title
Serum leucine incremental area under the curve (iAUC) [micromol/L*min].
Time Frame
Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Title
Time to reach half the serum leucine iAUC (t½) [minutes].
Time Frame
Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Title
Maximum serum essential amino acid concentration (EAAmax) [micromol/L]
Time Frame
Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Title
Maximum serum amino acid concentration (AAmax) [mmol/L]
Time Frame
Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Title
Maximum serum insulin concentration [micromol/L].
Time Frame
Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Title
Serum insulin iAUC [micromol/L*min]
Time Frame
Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Title
Maximum serum glucose concentration [mmol/L]
Time Frame
Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Title
Serum glucose iAUC [mmol/L*min]
Time Frame
Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Title
Adverse events and (Gastro-Intestinal) tolerance questionnaire.
Time Frame
During the study and until one week after completion of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Ampha
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
25790724
Citation
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.
Results Reference
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Amino Acid Bioavailability in Healthy Elderly After Intake of an Oral Nutritional Supplement

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