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Completed

NCT Number: NCT02013466

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

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ampha

Nijmegen, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bolus ONS A

Dietary Supplement

High-whey protein, leucine-rich, low-caloric ONS in powder format

Bolus ONS B

Dietary Supplement

High casein-protein, low-caloric control product (isocaloric to product A)

Bolus ONS C

Dietary Supplement

High casein-protein, high-caloric control product.

Bolus ONS D

Dietary Supplement

high whey-protein, leucine-rich, high-caloric control product (isocaloric to product C)

Primary outcomes

  1. The primary outcome parameter in this study is the Maximum serum leucine concentration (Leumax) [micromol/L].

    Time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)

Secondary outcomes

  1. Serum leucine incremental area under the curve (iAUC) [micromol/L*min].

    Time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)

  2. Time to reach half the serum leucine iAUC (t½) [minutes].

    Time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)

  3. Maximum serum essential amino acid concentration (EAAmax) [micromol/L]

    Time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)

  4. Maximum serum amino acid concentration (AAmax) [mmol/L]

    Time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)

  5. Maximum serum insulin concentration [micromol/L].

    Time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)

  6. Serum insulin iAUC [micromol/L*min]

    Time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)

  7. Maximum serum glucose concentration [mmol/L]

    Time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)

  8. Serum glucose iAUC [mmol/L*min]

    Time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)

  9. Adverse events and (Gastro-Intestinal) tolerance questionnaire.

    Time frame: During the study and until one week after completion of the study

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Registry information

Official study title

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

Acronym: ArenA

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 17, 2013
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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