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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Oral Placebo; Other: Enteral Protein; Other: Oral Protein

• Registration Number: NCT03571425
• Lead Sponsor: University of Exeter

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2018-05-24
• Study Start: 2018-06-04
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-06-27
• Status Verified: 2018-12
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Placebo	Oral Placebo	Placebo drink
Enteral Protein	Enteral Protein	Protein drink, administered via enteral tube
Oral Protein	Oral Protein	Protein drink, ingested orally

Primary Outcome Measures

Name	Time	Method
Postprandial muscle protein synthesis	5 hours	Muscle protein synthesis rate (FSR) following ingestion of a placebo or protein supplement

Secondary Outcome Measures

Name	Time	Method
Postabsorptive muscle protein synthesis	2 hours	Muscle protein synthesis rate (FSR, in %/h) during a 2 hour fasting period
Whole-body protein synthesis	7 hours	Whole-body protein synthesis, measured using a D5 phenylalanine and D2 tyrosine infusion (umol Phenylalanine/kg/h)
Whole-body protein breakdown	7 hours	Whole-body protein breakdown, measured using a D5 phenylalanine and D2 tyrosine infusion (umol Phenylalanine/kg/h)
Whole-body protein oxidation	7 hours	Whole-body protein oxidation, measured using a D5 phenylalanine and D2 tyrosine infusion (umol Phenylalanine/kg/h)
Whole-body protein net balance	7 hours	Whole-body protein net balance, measured using a D5 phenylalanine and D2 tyrosine infusion (umol Phenylalanine/kg/h)
Gastric emptying rate	5 hours	Gastric emptying rate following ingestion of a placebo or protein drink
Blood glucose concentration	8.5 hours	Blood glucose concentration in the postabsorptive and postprandial phase following placebo/protein ingestion
Serum insulin concentration	8.5 hours	Serum insulin concentration in the postabsorptive and postprandial phase following placebo/protein ingestion

Trial Locations

Locations (1)

University of Exeter; 🇬🇧 Exeter, Devon, United Kingdom