Sarcopenia
Conditions
Keywords
Bioavailability, Amino Acids, Elderly, Supplement
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.
Interventions
DIETARY_SUPPLEMENTBolus ONS A
High-whey protein, leucine-rich, low-caloric ONS in powder format
DIETARY_SUPPLEMENTBolus ONS B
High casein-protein, low-caloric control product (isocaloric to product A)
DIETARY_SUPPLEMENTBolus ONS C
High casein-protein, high-caloric control product.
DIETARY_SUPPLEMENTBolus ONS D
high whey-protein, leucine-rich, high-caloric control product (isocaloric to product C)
Sponsors
Nutricia Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
| 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 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 |
| Serum insulin iAUC [micromol/L*min] | Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits) |
Countries
Netherlands
Outcome results
None listed