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

Phase 1

Completed

• Conditions: Sarcopenia
• Interventions: Dietary Supplement: Bolus ONS A; Dietary Supplement: Bolus ONS B; Dietary Supplement: Bolus ONS C; Dietary Supplement: Bolus ONS D

• Registration Number: NCT02013466
• Lead Sponsor: Nutricia Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2013-12
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-11
• Last Update Submitted: 2013-12-11
• Study First Posted: 2013-12-17
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bolus ONS intake	Bolus ONS A	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.
Bolus ONS intake	Bolus ONS B	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.
Bolus ONS intake	Bolus ONS C	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.
Bolus ONS intake	Bolus ONS D	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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)
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

Trial Locations

Locations (1)

Ampha; 🇳🇱 Nijmegen, Netherlands