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AIMS To determine the effect of high and low sucrose diets on liver fat in healthy adult men with liver fat levels below 5%
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High sucrose diet | Experimental | High sucrose diet for 7 days |
|
| Low sucrose diet | Experimental | Low sucrose diet for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sucrose | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Liver Fat | Liver fat was assessed by magnetic resonance spectrometry (MRS) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Fasting Triglyceride Levels | Triglyceride levels assessed from plasma in fasting state | Baseline and 7 days |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Frost | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIHR/Wellcome Trust Imperial Clinical Research Facility | London | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | High Sucrose Diet Then Low Sucrose | High sucrose diet for 7 days, then low sucrose diet |
| FG001 | Low Sucrose Diet Then High Sucrose | Low sucrose diet for 7 days for first intervention, then high sucrose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (7 Days) |
| |||||||||||||
| Wash-out (4 Weeks) |
| |||||||||||||
| Second Intervention (7 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants, cross-over study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change in Liver Fat | Liver fat was assessed by magnetic resonance spectrometry (MRS) | Posted | Mean | Standard Deviation | percentage of change | 7 days |
|
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Sucrose Diet | High sucrose diet for 7 days | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Gary Frost | Imperial College London | 020 7594 0959 | g.frost@imperial.ac.uk |
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| ID | Term |
|---|---|
| D013395 | Sucrose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Changes in Fasting Triglyceride Levels | Triglyceride levels assessed from plasma in fasting state | Posted | Mean | Standard Deviation | mmol/l | Baseline and 7 days |
|
|
|
|
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Low Sucrose Diet | Low sucrose diet for 7 days | 0 | 9 | 0 | 9 | 0 | 9 |
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| D000073893 |
| Sugars |
| 0.244 |
| Superiority |
| ANOVA | 0.244 | Superiority |