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

December 11, 2013 updated by: Nutricia Research

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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.
Dietary supplement: Bolus ONS A
High-whey protein, leucine-rich, low-caloric ONS in powder format
Dietary supplement: Bolus ONS B
High casein-protein, low-caloric control product (isocaloric to product A)
Dietary supplement: Bolus ONS C
High casein-protein, high-caloric control product.
Dietary supplement: Bolus ONS D
high whey-protein, leucine-rich, high-caloric control product (isocaloric to product C)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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)
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].
Time Frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
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]
Time Frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
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]
Time Frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
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)
Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
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)
Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
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)
Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
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)
Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Adverse events and (Gastro-Intestinal) tolerance questionnaire.
Time Frame: During the study and until one week after completion of the study
During the study and until one week after completion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nutricia Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Sip.1.C/B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings