Hepatic Fatty Acid MetabolismNCT01050140
The Metabolic Effects of a High Fructose Versus a High Glucose Diet in Overweight Men
A study testing high sugar diet in people with Hepatic Fatty Acid Metabolism and Systemic Insulin Resistance, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Dietary consumption of fructose has increased by nearly 50% since 1960. A high fructose diet (HFrD) results in greater visceral adiposity and systemic insulin resistance than a high glucose diet. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatic Fatty Acid Metabolism, Systemic Insulin Resistance, Oxidative Stress
- What is being tested?
- high sugar diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Apr 2011
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index 25-32
- Waist > hip circumference
- Age 18-50 years
- Male
Who cannot join
- Reported weight change > 3 kg in prior 3/12
- Active health problems
- Contraindications to MRI scanning
- Symptoms of functional bloating or irritable bowel syndrome
- Abnormal liver or renal function tests
- Random glucose greater than 11.0 mmol/L
Show all 11Show fewer
- Evidence of metabolic or viral liver disease as screened for by hepatitis B and C serology, and ferritin.
- Alcohol intake > 21 units per week
- Vegetarianism
- Normal daily fructose intake from drinks greater than that in 500ml of coca cola
- Abnormal carbohydrate energy contribution to baseline diet - defined as greater than 2 standard deviations from the mean of the National Diet and Nutrition Survey 2002 data
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Biomedical Sciences, University of Nottingham
Nottingham, Nottinghamshire, NG7 2UH
About this study
Dietary consumption of fructose has increased by nearly 50% since 1960.
A high fructose diet (HFrD) results in greater visceral adiposity and systemic insulin resistance than a high glucose diet. The effects of fructose on liver fatty acid and ATP stores, systemic oxidative stress and cardiovascular status are not fully known.
Read the detailed description
The protocol will assess the following outcomes:
- The ultimate fate of this increased hepatic fatty acid production following a high fructose vs. glucose diet
- The effect of a high fructose vs. glucose diet on liver ATP stores
- The effect of a high fructose vs. glucose diet on markers of oxidative stress
- The effect of a high fructose vs. glucose diet on cardiovascular status
Factors critical to carbohydrate metabolism such as systemic insulin resistance, body composition, energy expenditure, physical activity will also be assessed.
32 centrally overweight healthy males with a low baseline fructose intake will be recruited. They will be randomised double blindly to receive 25% of their dietary energy requirements from either fructose or glucose for 14 days.
The sugars will first be taken in an energy balanced and then an overfeeding setting.
- Conditions
- Hepatic Fatty Acid Metabolism, Systemic Insulin Resistance, Oxidative Stress, Cardiovascular Status
- Being tested
- high sugar diet
- Keywords
- fructose, fatty liver disease, diet
- 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.
high sugar dietDietary supplement
25% of dietary energy from fructose or glucose
| Study group | Role | What they receive |
|---|---|---|
| fructose | Experimental | 25% dietary energy from fructose Receives: Dietary Supplement: high sugar diet |
| glucose | Active comparator | 25% dietary energy from glucose Receives: Dietary Supplement: high sugar diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver triglyceride content
Measured: 2 weeks
Secondary outcomes (8)
Muscle triglyceride content
Measured: 2 weeks
Total abdominal visceral fat content (MRI)
Measured: 2 weeks
Liver ATP, PME concentration and pH (31P MRS)
Measured: 2 weeks
Liver de novo lipogenesis
Measured: 2 weeks
Resting energy expenditure, lipid and carbohydrate oxidation rates
Measured: 2 weeks
Hepatic and systemic insulin resistance
Measured: 2 weeks
Cardiovascular measures using finometry
Measured: 2 weeks
Systemic oxidative stress and inflammatory cytokine profile
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic Fatty Acid MetabolismStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian A Macdonald, PhD, Study chair, School of Biomedical Sciences, Nottingham University, UKRichard D Johnston, MRCP, Principal investigator, School of Biomedical Sciences, Nottingham University, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050140
- Sponsor's protocol ID
- D/10/2009
- Status last verified
- Jul 2012
- First submitted
- 14 Jan 2010
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnston RD, Stephenson MC, Crossland H, Cordon SM, Palcidi E, Cox EF, Taylor MA, Aithal GP, Macdonald IA. No difference between high-fructose and high-glucose diets on liver triacylglycerol or biochemistry in healthy overweight men. Gastroenterology. 2013 Nov;145(5):1016-1025.e2. doi: 10.1053/j.gastro.2013.07.012. Epub 2013 Jul 19.
PubMed 23872500
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Effects of a High Fructose Versus a High Glucose Diet in Overweight Men
- ClinicalTrials.gov ID
- NCT01050140
- Acronym / sponsor ID
- D/10/2009
- Conditions
- Hepatic Fatty Acid Metabolism, Systemic Insulin Resistance, Oxidative Stress, Cardiovascular Status
- Keywords
- fructose, fatty liver disease, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 15 Jan 2010 (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.
Dietary consumption of fructose has increased by nearly 50% since 1960.
A high fructose diet (HFrD) results in greater visceral adiposity and systemic insulin resistance than a high glucose diet. The effects of fructose on liver fatty acid and ATP stores, systemic oxidative stress and cardiovascular status are not fully known.
Detailed description
The protocol will assess the following outcomes:
- The ultimate fate of this increased hepatic fatty acid production following a high fructose vs. glucose diet
- The effect of a high fructose vs. glucose diet on liver ATP stores
- The effect of a high fructose vs. glucose diet on markers of oxidative stress
- The effect of a high fructose vs. glucose diet on cardiovascular status
Factors critical to carbohydrate metabolism such as systemic insulin resistance, body composition, energy expenditure, physical activity will also be assessed.
32 centrally overweight healthy males with a low baseline fructose intake will be recruited. They will be randomised double blindly to receive 25% of their dietary energy requirements from either fructose or glucose for 14 days.
The sugars will first be taken in an energy balanced and then an overfeeding setting.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fructose | Experimental | Dietary Supplement: high sugar diet25% dietary energy from fructose |
| glucose | Active comparator | Dietary Supplement: high sugar diet25% dietary energy from glucose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index 25-32
- Waist > hip circumference
- Age 18-50 years
- Male
Key exclusion criteria (11 listed)
- Reported weight change > 3 kg in prior 3/12
- Active health problems
- Contraindications to MRI scanning
- Symptoms of functional bloating or irritable bowel syndrome
- Abnormal liver or renal function tests
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 |
|---|---|---|
| high sugar diet25% of dietary energy from fructose or glucose | Dietary supplement | fructose, glucose |
Primary outcome
Liver triglyceride content
Time frame: 2 weeks
8 secondary outcomes
Muscle triglyceride content
Time frame: 2 weeks
Total abdominal visceral fat content (MRI)
Time frame: 2 weeks
Liver ATP, PME concentration and pH (31P MRS)
Time frame: 2 weeks
Liver de novo lipogenesis
Time frame: 2 weeks
Resting energy expenditure, lipid and carbohydrate oxidation rates
Time frame: 2 weeks
Hepatic and systemic insulin resistance
Time frame: 2 weeks
Cardiovascular measures using finometry
Time frame: 2 weeks
Systemic oxidative stress and inflammatory cytokine profile
Time frame: 2 weeks
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 4 Jul 2012.
- Derived from this study: PubMed 23872500Johnston RD, Stephenson MC, Crossland H, Cordon SM, Palcidi E, Cox EF, Taylor MA, Aithal GP, Macdonald IA. No difference between high-fructose and high-glucose diets on liver triacylglycerol or biochemistry in healthy overweight men. Gastroenterology. 2013 Nov;145(5):1016-1025.e2. doi: 10.1053/j.gastro.2013.07.012. Epub 2013 Jul 19.
Related trials for Hepatic Fatty Acid Metabolism
Not yet recruitingPhase 2
The Effects of Glucagon on Hepatic Metabolism in People With Type 2 Diabetes After Caloric Restriction
Type2diabetes
Recruiting
Adipose Tissue Storage in the Rapid Remission of Hepatic and Cardiac Metabolic Dysfunction After Bariatric Surgery
Diabetes Mellitus Type 2
Not yet recruiting
How Abnormal Function of Fat Tissue in Type 1 Diabetes Contributes to Fat in the Liver
Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-Alcoholic Steato-Hepatitis (NASH)
Enrolling by invitationObservational study
Elucidating Hepatic Metabolism in Non-alcoholic Fatty Liver Disease
Non-alcoholic Fatty Liver Disease (NAFLD)
Enrolling by invitation
Hepatic Mitochondrial Metabolism in Fatty Liver Disease in Humans
Non-alcoholic Fatty Liver Disease NAFLD
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.
Ian A Macdonald, PhD study chair
School of Biomedical Sciences, Nottingham University, UK
Richard D Johnston, MRCP principal investigator
School of Biomedical Sciences, Nottingham University, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high sugar diet in people with Hepatic Fatty Acid Metabolism and Systemic Insulin Resistance, run by University of Nottingham 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 11 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 4 Jul 2012. 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?
Liver triglyceride content (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01050140, which also lists 1 linked publication.
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 4 Jul 2012.