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

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: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: Bolus ONS A; Dietary supplement: Bolus ONS B; Dietary supplement: Bolus ONS C; Dietary supplement: Bolus ONS D

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • Ampha

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Nutricia Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: December 2, 2013
• First Submitted That Met QC Criteria: December 11, 2013
• First Posted (Estimate): December 17, 2013

Study Record Updates

• Last Update Posted (Estimate): December 17, 2013
• Last Update Submitted That Met QC Criteria: December 11, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Elderly; Bioavailability; Amino Acids; Supplement
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: Sip.1.C/B