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Completed

NCT Number: NCT03571425

The Impact of Enteral Versus Oral Protein Feeding on Muscle Protein Synthesis in Healthy Young Males and Females

The present study will seek to quantify the muscle protein synthetic response to a protein beverage consumed orally or through a nasogastric tube in healthy, young individuals.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

About this study

Thirty healthy, young volunteers will receive a stable isotope tracer infusion (8.5h) combined with repeated blood and muscle sampling, in order to measure muscle protein synthesis rate in the postabsorptive state, and following oral placebo ingestion (n=10), oral protein ingestion (n=10), or enteral protein administration (n=10).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18-40 years of age
  • Body mass index between 18.5 and 30

Exclusion criteria

  • Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
  • Any diagnosed cardiovascular disease
  • Elevated blood pressure at the time of screening. (An average systolic blood pressure reading of ≥140 mmHg over two or more measurements and an average diastolic blood pressure of ≥90 mmHg over two or more measurements)
  • Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism). This excludes oral contraceptives and contraceptive devices.
  • A personal or family history of epilepsy, seizures or schizophrenia.
  • Presence of an ulcer in the stomach or gut and/or strong history of indigestion
  • Known pre-existing liver disease/condition
  • Any known disorders in muscle metabolism
  • Regular use of nutritional supplements
  • Allergy to lidocaine
  • Allergy to milk
  • Current paracetamol use (i.e. use of paracetamol more than once a week)
  • Pregnancy

Treatment and study plan

Oral Placebo

Other

A placebo beverage will be consumed orally

Oral Protein

Other

A protein beverage will be consumed orally

Enteral Protein

Other

A protein beverage will be consumed via a naso-gastric feeding tube

Primary outcomes

  1. Postprandial muscle protein synthesis

    Time frame: 5 hours

    Muscle protein synthesis rate (FSR) following ingestion of a placebo or protein supplement

Secondary outcomes

  1. Postabsorptive muscle protein synthesis

    Time frame: 2 hours

    Muscle protein synthesis rate (FSR, in %/h) during a 2 hour fasting period

  2. Whole-body protein synthesis

    Time frame: 7 hours

    Whole-body protein synthesis, measured using a D5 phenylalanine and D2 tyrosine infusion (umol Phenylalanine/kg/h)

  3. Whole-body protein breakdown

    Time frame: 7 hours

    Whole-body protein breakdown, measured using a D5 phenylalanine and D2 tyrosine infusion (umol Phenylalanine/kg/h)

  4. Whole-body protein oxidation

    Time frame: 7 hours

    Whole-body protein oxidation, measured using a D5 phenylalanine and D2 tyrosine infusion (umol Phenylalanine/kg/h)

  5. Whole-body protein net balance

    Time frame: 7 hours

    Whole-body protein net balance, measured using a D5 phenylalanine and D2 tyrosine infusion (umol Phenylalanine/kg/h)

  6. Gastric emptying rate

    Time frame: 5 hours

    Gastric emptying rate following ingestion of a placebo or protein drink

  7. Blood glucose concentration

    Time frame: 8.5 hours

    Blood glucose concentration in the postabsorptive and postprandial phase following placebo/protein ingestion

  8. Serum insulin concentration

    Time frame: 8.5 hours

    Serum insulin concentration in the postabsorptive and postprandial phase following placebo/protein ingestion

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 27, 2018
Registry last updated
Dec 20, 2018

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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