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

NCT ID: NCT03571425

Last Updated: 2018-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-04

Study Completion Date

2018-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oral Placebo

Placebo drink

Group Type PLACEBO_COMPARATOR

Oral Placebo

Intervention Type OTHER

A placebo beverage will be consumed orally

Oral Protein

Protein drink, ingested orally

Group Type ACTIVE_COMPARATOR

Oral Protein

Intervention Type OTHER

A protein beverage will be consumed orally

Enteral Protein

Protein drink, administered via enteral tube

Group Type ACTIVE_COMPARATOR

Enteral Protein

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral Placebo

A placebo beverage will be consumed orally

Intervention Type OTHER

Oral Protein

A protein beverage will be consumed orally

Intervention Type OTHER

Enteral Protein

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Exeter

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marlou Dirks, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Exeter

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Exeter

Exeter, Devon, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

180509/B/03

Identifier Type: -

Identifier Source: org_study_id