- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02535897
Protein Ingestion and Muscle Carnitine Uptake
August 28, 2015 updated by: University of Nottingham
The Effects of an Insulinotropic Protein-carbohydrate Beverage on L- Carnitine Absorption and Muscle Carnitine Uptake
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy
- Body mass index of 18-25 kg/cm2
Exclusion Criteria:
- Unhealthy
- Smoker
- Taking any medication that interferes with skeletal muscle metabolism
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: CON
500 ml of flavoured water
|
|
Active Comparator: CHO
500 ml of flavoured water containing 80 g carbohydrate
|
|
Active Comparator: CHO-PRO
500 ml of flavoured water containing 40 g carbohydrate and 40 g whey protein
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle carnitine uptake
Time Frame: 180 minutes
|
Change in forearm carnitine uptake (measured using arterialised-venous - venous balance technique) in response to intervention.
|
180 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
August 24, 2015
First Submitted That Met QC Criteria
August 28, 2015
First Posted (Estimate)
August 31, 2015
Study Record Updates
Last Update Posted (Estimate)
August 31, 2015
Last Update Submitted That Met QC Criteria
August 28, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- G26062012 BMS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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