Healthy VolunteersNCT02015442
Effect of Sucrose on Liver Fat
A study testing Sucrose in people with Healthy Volunteers, run by Imperial College London at 1 site in United Kingdom.
Trial summary
AIMS To determine the effect of high and low sucrose diets on liver fat in healthy adult men with liver fat levels below 5% Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Sucrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men aged between 20 and 40 years with BMI between 20-25 kg/m2 and with normal liver fat levels (<5%), normal fasting glucose (less than 5.5mmol/l) and HbA1C less than 5.7% will be eligible to volunteer.
Who cannot join
- Type 1 diabetes, Type 2 diabetes, hypertension or hyperlipidaemia
- Gained or lost ≥ 3kg weight in the past three months
- Use of medication likely to interfere with metabolism, appetite regulation, glucose homeostasis and hormonal balance
- Regular consumer of sugar sweetened beverages
- Any chronic illness
- Cardiovascular, hepatic or renal disease
Show all 13Show fewer
- Excess alcohol intake (>2 units per day)
- Exceeding UK minimum activity recommendation (30min moderate exercise 5d/wk)
- Current smokers (smoked within last 6 months)
- Any gastrointestinal disorder e.g. Crohn's disease, coeliac disease or irritable bowel syndrome
- A history of drug or alcohol abuse in the last 2 years
- Pancreatitis
- Unable to have MRI (eg. metallic or magnetic implants, claustrophobia)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR/Wellcome Trust Imperial Clinical Research Facility
London
About this study
Official title: Effect of Eucaloric High and Low Sucrose Diets on Liver Fat in Healthy Adult Men With Liver Fat Levels Below 5%
AIMS To determine the effect of high and low sucrose diets on liver fat in healthy adult men with liver fat levels below 5%
Read the detailed description
DESIGN Randomized, cross-over design with two 7-day dietary interventions separated by a 4 week wash-out period. Dietary intervention will be based on iso-energetic substitution of sucrose for starch in a weight-maintaining diet. The two experimental conditions are: high sucrose diet at 25% of total energy intake (this is approximately the 95th percentile for UK intake of non-milk extrinsic sugars (NMES)); and low sucrose diet at 10% of total energy intake. Otherwise the macronutrient balance in both conditions will be based on UK average habitual intake.
POPULATION 10 healthy males aged between 20 and 40 years, with a BMI between 20-25kg/m2, with normal liver fat levels (<5%) and fasting plasma glucose and no evidence of insulin resistance will be recruited. No pre-existing morbidity including cardiac, hepatic or renal disease, history of diabetes, hypertension or hyperlipidemia. Usual physical activity of subjects to range from sedentary to a maximum of meeting the UK minimum activity recommendations (30 min moderate exercise 5 d/week). Habitual alcohol intake of less than 2 units per day.
TREATMENT Pre-intervention: Participants will be asked to record habitual dietary intake by completion of a 7-day food diary and be asked to wear an accelerometer armband to assess physical activity before each intervention week. Resting energy expenditure will also be assessed by indirect calorimetry.
7 day dietary interventions: Participants will be resident at the clinical research facility at Hammersmith Hospital during each intervention week for 5 out of the 7 days and all food will be provided at the facility. At the weekends, participants will have to leave the unit but food will be provided for those two days so that the diet can be continued at home.
At the start and end of each 7 day intervention: Weight, height and waist circumference will be taken; percentage liver fat and total and regional body composition will be measured by MRI. Fasting and post prandial plasma glucose, insulin and lipids will be measured and blood pressure.
- Conditions
- Healthy Volunteers
- Being tested
- Sucrose
- Keywords
- Sucrose in diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucroseDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| High sucrose diet | Experimental | High sucrose diet for 7 days Receives: Dietary Supplement: Sucrose |
| Low sucrose diet | Experimental | Low sucrose diet for 7 days Receives: Dietary Supplement: Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Liver Fat
Liver fat was assessed by magnetic resonance spectrometry (MRS)
Measured: 7 days
Secondary outcomes (1)
Changes in Fasting Triglyceride Levels
Triglyceride levels assessed from plasma in fasting state
Measured: Baseline and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary Frost, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015442
- Sponsor's protocol ID
- SucroseLiver
- Status last verified
- Nov 2019
- First submitted
- 13 Dec 2013
- Last updated
- 14 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Eucaloric High and Low Sucrose Diets on Liver Fat in Healthy Adult Men With Liver Fat Levels Below 5%
- ClinicalTrials.gov ID
- NCT02015442
- Acronym / sponsor ID
- SucroseLiver
- Conditions
- Healthy Volunteers
- Keywords
- Sucrose in diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Posted 14 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AIMS To determine the effect of high and low sucrose diets on liver fat in healthy adult men with liver fat levels below 5%
Detailed description
DESIGN Randomized, cross-over design with two 7-day dietary interventions separated by a 4 week wash-out period. Dietary intervention will be based on iso-energetic substitution of sucrose for starch in a weight-maintaining diet. The two experimental conditions are: high sucrose diet at 25% of total energy intake (this is approximately the 95th percentile for UK intake of non-milk extrinsic sugars (NMES)); and low sucrose diet at 10% of total energy intake. Otherwise the macronutrient balance in both conditions will be based on UK average habitual intake.
POPULATION 10 healthy males aged between 20 and 40 years, with a BMI between 20-25kg/m2, with normal liver fat levels (<5%) and fasting plasma glucose and no evidence of insulin resistance will be recruited. No pre-existing morbidity including cardiac, hepatic or renal disease, history of diabetes, hypertension or hyperlipidemia. Usual physical activity of subjects to range from sedentary to a maximum of meeting the UK minimum activity recommendations (30 min moderate exercise 5 d/week). Habitual alcohol intake of less than 2 units per day.
TREATMENT Pre-intervention: Participants will be asked to record habitual dietary intake by completion of a 7-day food diary and be asked to wear an accelerometer armband to assess physical activity before each intervention week. Resting energy expenditure will also be assessed by indirect calorimetry.
7 day dietary interventions: Participants will be resident at the clinical research facility at Hammersmith Hospital during each intervention week for 5 out of the 7 days and all food will be provided at the facility. At the weekends, participants will have to leave the unit but food will be provided for those two days so that the diet can be continued at home.
At the start and end of each 7 day intervention: Weight, height and waist circumference will be taken; percentage liver fat and total and regional body composition will be measured by MRI. Fasting and post prandial plasma glucose, insulin and lipids will be measured and blood pressure.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High sucrose diet | Experimental | Dietary Supplement: SucroseHigh sucrose diet for 7 days |
| Low sucrose diet | Experimental | Dietary Supplement: SucroseLow sucrose diet for 7 days |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy men aged between 20 and 40 years with BMI between 20-25 kg/m2 and with normal liver fat levels (<5%), normal fasting glucose (less than 5.5mmol/l) and HbA1C less than 5.7% will be eligible to volunteer.
Key exclusion criteria (13 listed)
- Type 1 diabetes, Type 2 diabetes, hypertension or hyperlipidaemia
- Gained or lost ≥ 3kg weight in the past three months
- Use of medication likely to interfere with metabolism, appetite regulation, glucose homeostasis and hormonal balance
- Regular consumer of sugar sweetened beverages
- Any chronic illness
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 |
|---|---|---|
| Sucrose | Dietary supplement | High sucrose diet, Low sucrose diet |
Primary outcome
Percentage Change in Liver Fat
Time frame: 7 days
Liver fat was assessed by magnetic resonance spectrometry (MRS)
1 secondary outcome
Changes in Fasting Triglyceride Levels
Time frame: Baseline and 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Gary Frost principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sucrose in people with Healthy Volunteers, run by Imperial College London 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 1 inclusion and 13 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 14 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 14 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Change in Liver Fat (time frame: 7 days). 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 14 Nov 2019.