NCT02535897

Brief Summary

The purpose of this study is to assess the effects of a protein-carbohydrate beverage on the absorption of an orally ingested bolus of L-carnitine, compared to flavoured water and carbohydrate-only controls, and to determine whether increasing plasma carnitine availability can impact upon insulin-stimulated muscle carnitine uptake.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
Last Updated

August 31, 2015

Status Verified

August 1, 2015

Enrollment Period

7 months

First QC Date

August 24, 2015

Last Update Submit

August 28, 2015

Conditions

Muscle, Skeletal

Outcome Measures

Primary Outcomes (1)

  • Muscle carnitine uptake

    Change in forearm carnitine uptake (measured using arterialised-venous - venous balance technique) in response to intervention.

    180 minutes

Study Arms (3)

CON

PLACEBO COMPARATOR

500 ml of flavoured water

Dietary Supplement: Flavoured water

CHO

ACTIVE COMPARATOR

500 ml of flavoured water containing 80 g carbohydrate

Dietary Supplement: Flavoured water + carbohydrate

CHO-PRO

ACTIVE COMPARATOR

500 ml of flavoured water containing 40 g carbohydrate and 40 g whey protein

Dietary Supplement: Flavoured water + carbohydrate + protein

Interventions

Flavoured waterDIETARY_SUPPLEMENT
CON
Flavoured water + carbohydrateDIETARY_SUPPLEMENT
CHO
Flavoured water + carbohydrate + proteinDIETARY_SUPPLEMENT
CHO-PRO

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Body mass index of 18-25 kg/cm2

You may not qualify if:

  • Unhealthy
  • Smoker
  • Taking any medication that interferes with skeletal muscle metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

CarbohydratesProteins

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2015

First Posted

August 31, 2015

Study Start

July 1, 2013

Primary Completion

February 1, 2014

Study Completion

July 1, 2014

Last Updated

August 31, 2015

Record last verified: 2015-08