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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02217605
Other study ID # A32006_FRU
Secondary ID
Status Completed
Phase N/A
First received August 12, 2014
Last updated August 14, 2014
Start date March 2011
Est. completion date December 2013

Study information

Verified date August 2014
Source University of Nottingham
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Institute for Health Research
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effects of an oral fructose challenge on liver adenosine triphosphate (ATP) reserves using 31P magnetic resonance spectroscopy (MRS) as a potential measure measure of liver health.


Description:

This study uses 31P spectra acquired from the liver in healthy subjects following a fructose drink to monitor ATP levels. This is also related to baseline BMI, liver glycogen and liver lipid levels


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- Male

- Age 18 - 30

- BMI 20 - 27 kg/m^2

- Healthy

Exclusion Criteria:

- Smokers

- Liver disease or Metabolic Disorders

- Metal implants (not suitable for MRI)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Fructose
Oral Fructose Challenge (75 g fructose in 500 ml water) following overnight fast

Locations

Country Name City State
United Kingdom University of Nottingham Nottingham Nottinghamshire

Sponsors (3)

Lead Sponsor Collaborator
Stephen Bawden Biotechnology and Biological Sciences Research Council, Unilever R&D

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hepatic ATP reserves following an oral fructose challenge Monitor hepatic ATP levels following an oral fructose challenge using 31P magnetic resonance spectroscopy 2 hours post prandial No
Secondary Correlate hepatic ATP depletion / recovery with BMI, liver lipids and liver glycogen Measure baseline liver lipid and glycogen using magnetic resonance spectroscopy and correlate BMI, lipid and glycogen levels with rate of ATP depletion and recovery following an oral fructose challenge 2 hours post prandial No
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