31PMRS_FRU: 31P Magnetic Resonance Spectroscopy Fructose Study

Sponsor

Stephen Bawden (Other)

Overall Status

Completed

CT.gov ID

NCT02217605

Collaborator

Biotechnology and Biological Sciences Research Council (Other), Unilever R&D (Industry)

Enrollment

Location

Arm

33.1

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Fructose	N/A

Detailed 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

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Investigating the Effects of an Oral Fructose Challenge on Hepatic ATP Reserves in Healthy Volunteers

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fructose Oral Fructose Challenge (75 g fructose in 500 ml water) followed by 75 minutes 31P MRS	Dietary Supplement: Fructose Oral Fructose Challenge (75 g fructose in 500 ml water) following overnight fast

Arm

Intervention/Treatment

Experimental: Fructose

Oral Fructose Challenge (75 g fructose in 500 ml water) followed by 75 minutes 31P MRS

Dietary Supplement: Fructose

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

Outcome Measures

Primary Outcome Measures

Hepatic ATP reserves following an oral fructose challenge [2 hours post prandial]
Monitor hepatic ATP levels following an oral fructose challenge using 31P magnetic resonance spectroscopy

Secondary Outcome Measures

Correlate hepatic ATP depletion / recovery with BMI, liver lipids and liver glycogen [2 hours post prandial]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nottingham	Nottingham	Nottinghamshire	United Kingdom	NG7 2RD

Sponsors and Collaborators

Stephen Bawden
Biotechnology and Biological Sciences Research Council
Unilever R&D

Investigators

Principal Investigator: Luca Marciani, University of Nottingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stephen Bawden, CASE studentship researcher, University of Nottingham

ClinicalTrials.gov Identifier:

NCT02217605

Other Study ID Numbers:

A32006_FRU

First Posted:

Aug 15, 2014

Last Update Posted:

Aug 15, 2014

Last Verified:

Aug 1, 2014

Keywords provided by Stephen Bawden, CASE studentship researcher, University of Nottingham

NAFLD

Oral Fructose Challenge

31P MRS

Liver

Subjects

Study Results

No Results Posted as of Aug 15, 2014