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

Nutricia

Status and phase: Completed; Phase 1

Conditions: Sarcopenia

Treatments: Dietary Supplement: Bolus ONS C; Dietary Supplement: Bolus ONS A; Dietary Supplement: Bolus ONS B; Dietary Supplement: Bolus ONS D

Study type: Interventional

Funder types: Industry

Identifiers

NCT02013466

Sip.1.C/B

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 1 patient group

Bolus ONS intake

Other group

Description:

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.

Treatment:

Dietary Supplement: Bolus ONS C

Dietary Supplement: Bolus ONS A

Dietary Supplement: Bolus ONS B

Dietary Supplement: Bolus ONS D