31P Magnetic Resonance Spectroscopy Fructose Study (31PMRS_FRU)

August 14, 2014 updated by: Stephen Bawden

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, Ng7 2RD
        • University of Nottingham

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 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatic ATP reserves following an oral fructose challenge
Time Frame: 2 hours post prandial
Monitor hepatic ATP levels following an oral fructose challenge using 31P magnetic resonance spectroscopy
2 hours post prandial

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlate hepatic ATP depletion / recovery with BMI, liver lipids and liver glycogen
Time Frame: 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
2 hours post prandial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stephen Bawden

Collaborators

Biotechnology and Biological Sciences Research Council
Unilever R&D

Investigators

  • Principal Investigator: Luca Marciani, University of Nottingham

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

March 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 12, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Estimate)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 14, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A32006_FRU

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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