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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Oral Placebo; Other: Oral Protein; Other: Enteral Protein

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, EX1 2LU
      • University of Exeter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Oral Placebo; Placebo drink	Other: Oral Placebo; A placebo beverage will be consumed orally
Active Comparator: Oral Protein; Protein drink, ingested orally	Other: Oral Protein; A protein beverage will be consumed orally
Active Comparator: Enteral Protein; Protein drink, administered via enteral tube	Other: Enteral Protein; A protein beverage will be consumed via a naso-gastric feeding tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial muscle protein synthesis	Muscle protein synthesis rate (FSR) following ingestion of a placebo or protein supplement	5 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Exeter
• Investigators: Principal Investigator: Marlou Dirks, PhD, University of Exeter

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2018
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): June 27, 2018

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 180509/B/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes