Clinical trial NCT02013466: Amino Acid Bioavailability in Healthy Elderly After Intake of an Oral Nutritional Supplement
Official title: Amino Acid Bioavailability in Healthy Elderly After Bolus Intake of a High Whey-protein, Leucine-rich, Low-caloric Oral Nutritional Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sarcopenia
Keywords: Bioavailability
Amino Acids
Elderly
Supplement
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2013-12-17
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The primary outcome parameter in this study is the Maximum serum leucine concentration (Leumax) [micromol/L].
timeFrame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Secondary outcomes:
measure: Serum leucine incremental area under the curve (iAUC) [micromol/L*min].
timeFrame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
measure: Time to reach half the serum leucine iAUC (t½) [minutes].
timeFrame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
measure: Maximum serum essential amino acid concentration (EAAmax) [micromol/L]
timeFrame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
measure: Maximum serum amino acid concentration (AAmax) [mmol/L]
timeFrame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
measure: Maximum serum insulin concentration [micromol/L].
timeFrame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
measure: Serum insulin iAUC [micromol/L*min]
timeFrame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
measure: Maximum serum glucose concentration [mmol/L]
timeFrame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
measure: Serum glucose iAUC [mmol/L*min]
timeFrame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
measure: Adverse events and (Gastro-Intestinal) tolerance questionnaire.
timeFrame: During the study and until one week after completion of the study
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Ampha
Study officials:
References:
citation: 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.