NCT02217605

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

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

March 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
Last Updated

August 15, 2014

Status Verified

August 1, 2014

Enrollment Period

2.5 years

First QC Date

August 12, 2014

Last Update Submit

August 14, 2014

Conditions

Healthy

Keywords

NAFLDOral Fructose Challenge31P MRSLiverSubjects

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Correlate hepatic ATP depletion / recovery with BMI, liver lipids and liver glycogen

    2 hours post prandial

Study Arms (1)

Fructose

EXPERIMENTAL

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

Dietary Supplement: Fructose

Interventions

FructoseDIETARY_SUPPLEMENT

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

Fructose

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Age 18 - 30
  • BMI 20 - 27 kg/m\^2
  • Healthy

You may not qualify if:

  • Smokers
  • Liver disease or Metabolic Disorders
  • Metal implants (not suitable for MRI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG7 2RD, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Fructose

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Luca Marciani

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
CASE studentship researcher

Study Record Dates

First Submitted

August 12, 2014

First Posted

August 15, 2014

Study Start

March 1, 2011

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

August 15, 2014

Record last verified: 2014-08

Locations

GB(1)