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

Sponsor

University of Exeter (Other)

Overall Status

Completed

CT.gov ID

NCT03571425

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Oral Placebo Other: Oral Protein Other: Enteral Protein	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

Oral conditions are double blinded to participant and investigator, but enteral vs oral feeding is not blinded

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jun 4, 2018

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Postprandial muscle protein synthesis [5 hours]
Muscle protein synthesis rate (FSR) following ingestion of a placebo or protein supplement

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Exeter	Exeter	Devon	United Kingdom	EX1 2LU

Sponsors and Collaborators

University of Exeter

Investigators

Principal Investigator: Marlou Dirks, PhD, University of Exeter

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Exeter

ClinicalTrials.gov Identifier:

NCT03571425

Other Study ID Numbers:

180509/B/03

First Posted:

Jun 27, 2018

Last Update Posted:

Dec 20, 2018

Last Verified:

Dec 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Study Results

No Results Posted as of Dec 20, 2018