Healthy31PMRS_FRUNCT02217605
31P Magnetic Resonance Spectroscopy Fructose Study
A study testing Fructose in people with Healthy, run by Stephen Bawden at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fructose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Age 18 - 30
- BMI 20 - 27 kg/m^2
- Healthy
Who cannot join
- Smokers
- Liver disease or Metabolic Disorders
- Metal implants (not suitable for MRI)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Nottinghamshire, NG7 2RD
About this study
Official title: 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.
Read the 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
- Conditions
- Healthy
- Being tested
- Fructose
- Keywords
- NAFLD, Oral Fructose Challenge, 31P MRS, Liver, Subjects
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FructoseDietary supplement
Oral Fructose Challenge (75 g fructose in 500 ml water) following overnight fast
| Study group | Role | What they receive |
|---|---|---|
| Fructose | Experimental | Oral Fructose Challenge (75 g fructose in 500 ml water) followed by 75 minutes 31P MRS Receives: Dietary Supplement: Fructose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic ATP reserves following an oral fructose challenge
Monitor hepatic ATP levels following an oral fructose challenge using 31P magnetic resonance spectroscopy
Measured: 2 hours post prandial
Secondary outcomes (1)
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
Measured: 2 hours post prandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startMar 2011
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen Bawden
- Sponsor type
- University, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Unilever R&D
- Responsible party
- Sponsor-investigator, Stephen Bawden, University of Nottingham
- Investigators
- Luca Marciani, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217605
- Sponsor's protocol ID
- A32006_FRU
- Acronym
- 31PMRS_FRU
- Status last verified
- Aug 2014
- First submitted
- 12 Aug 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of an Oral Fructose Challenge on Hepatic ATP Reserves in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02217605
- Acronym / sponsor ID
- 31PMRS_FRU / A32006_FRU
- Conditions
- Healthy
- Keywords
- NAFLD, Oral Fructose Challenge, 31P MRS, Liver, Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stephen BawdenUniversity, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Unilever R&D
- Study start
- Mar 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fructose | Experimental | Dietary Supplement: FructoseOral Fructose Challenge (75 g fructose in 500 ml water) followed by 75 minutes 31P MRS |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- Age 18 - 30
- BMI 20 - 27 kg/m^2
- Healthy
Key exclusion criteria (3 listed)
- Smokers
- Liver disease or Metabolic Disorders
- Metal implants (not suitable for MRI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FructoseOral Fructose Challenge (75 g fructose in 500 ml water) following overnight fast | Dietary supplement | Fructose |
Primary outcome
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
1 secondary outcome
Correlate hepatic ATP depletion / recovery with BMI, liver lipids and liver glycogen
Time frame: 2 hours post prandial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
Related trials for Healthy
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Marciani principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructose in people with Healthy, run by Stephen Bawden at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic ATP reserves following an oral fructose challenge (time frame: 2 hours post prandial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2014.