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

NCT02013466 | Completed Phase 1

• 1 other identifier: Sip.1.C/B
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

Bioavailability; Amino Acids; Elderly; Supplement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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)

Study Arms (1)

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.

Dietary Supplement: Bolus ONS A; Dietary Supplement: Bolus ONS B; Dietary Supplement: Bolus ONS C; Dietary Supplement: Bolus ONS D

Interventions

Bolus ONS A DIETARY_SUPPLEMENT

High-whey protein, leucine-rich, low-caloric ONS in powder format

Bolus ONS intake

Bolus ONS B DIETARY_SUPPLEMENT

High casein-protein, low-caloric control product (isocaloric to product A)

Bolus ONS intake

Bolus ONS C DIETARY_SUPPLEMENT

High casein-protein, high-caloric control product.

Bolus ONS intake

Bolus ONS D DIETARY_SUPPLEMENT

high whey-protein, leucine-rich, high-caloric control product (isocaloric to product C)

Bolus ONS intake

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or older
• BMI between 21 and 30 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (1)

Ampha

Nijmegen, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 25790724 DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 17, 2013
• Study Start: October 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

NL (1)