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

Sarcopenia Clinical Trial

— ArenA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02013466
• Other study ID #: Sip.1.C/B
• Status: Completed
• Phase: Phase 1
• First received: December 2, 2013
• Last updated: December 11, 2013
• Start date: October 2008
• Est. completion date: February 2009

Study information

• Verified date: December 2013
• Source: Nutricia Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• Bolus ONS A
High-whey protein, leucine-rich, low-caloric ONS in powder format
• Bolus ONS B
High casein-protein, low-caloric control product (isocaloric to product A)
• Bolus ONS C
High casein-protein, high-caloric control product.
• Bolus ONS D
high whey-protein, leucine-rich, high-caloric control product (isocaloric to product C)

Locations

Country	Name	City	State
Netherlands	Ampha	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Maximum serum insulin concentration [micromol/L].		Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)	No
Secondary	Serum insulin iAUC [micromol/L*min]		Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)	No
Secondary	Maximum serum glucose concentration [mmol/L]		Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)	No
Secondary	Serum glucose iAUC [mmol/L*min]		Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)	No
Secondary	Adverse events and (Gastro-Intestinal) tolerance questionnaire.		During the study and until one week after completion of the study	Yes