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

U

University of Exeter

Status

Completed

Conditions

Healthy

Treatments

Other: Oral Placebo
Other: Oral Protein
Other: Enteral Protein

Study type

Interventional

Funder types

Other

Identifiers

NCT03571425
180509/B/03

Details and patient eligibility

About

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.

Full description

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).

Enrollment

30 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 3 patient groups, including a placebo group

Oral Placebo
Placebo Comparator group
Description:
Placebo drink
Treatment:
Other: Oral Placebo
Oral Protein
Active Comparator group
Description:
Protein drink, ingested orally
Treatment:
Other: Oral Protein
Enteral Protein
Active Comparator group
Description:
Protein drink, administered via enteral tube
Treatment:
Other: Enteral Protein

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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