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

NCT03571425 | Completed

• 1 other identifier: 180509/B/03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Postprandial muscle protein synthesis

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

  5 hours

Secondary Outcomes (8)

• Postabsorptive muscle protein synthesis

  2 hours

• Whole-body protein synthesis

  7 hours

• Whole-body protein breakdown

  7 hours

• Whole-body protein oxidation

  7 hours

• Whole-body protein net balance

  7 hours

Study Arms (3)

Oral Placebo

PLACEBO COMPARATOR

Placebo drink

Other: Oral Placebo

Oral Protein

ACTIVE COMPARATOR

Protein drink, ingested orally

Other: Oral Protein

Enteral Protein

ACTIVE COMPARATOR

Protein drink, administered via enteral tube

Other: Enteral Protein

Interventions

Oral Placebo OTHER

A placebo beverage will be consumed orally

Oral Placebo

Oral Protein OTHER

A protein beverage will be consumed orally

Oral Protein

Enteral Protein OTHER

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

Enteral Protein

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Body mass index between 18.5 and 30

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead

Study Sites (1)

University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

MeSH Terms

Interventions

Proteins

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Marlou Dirks, PhD

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Oral conditions are double blinded to participant and investigator, but enteral vs oral feeding is not blinded
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 27, 2018
• Study Start: June 4, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)