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

Phase 1

Completed

• Conditions: Sarcopenia

• 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

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