Effect of Sucrose on Liver Fat
Study Details
Study Description
Brief 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%
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: High sucrose diet High sucrose diet for 7 days |
Dietary Supplement: Sucrose
|
Experimental: Low sucrose diet Low sucrose diet for 7 days |
Dietary Supplement: Sucrose
|
Outcome Measures
Primary Outcome Measures
- Percentage Change in Liver Fat [7 days]
Liver fat was assessed by magnetic resonance spectrometry (MRS)
Secondary Outcome Measures
- Changes in Fasting Triglyceride Levels [Baseline and 7 days]
Triglyceride levels assessed from plasma in fasting state
Eligibility Criteria
Criteria
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:
-
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
-
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)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | NIHR/Wellcome Trust Imperial Clinical Research Facility | London | United Kingdom |
Sponsors and Collaborators
- Imperial College London
Investigators
- Principal Investigator: Gary Frost, Imperial College London
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SucroseLiver
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | High Sucrose Diet Then Low Sucrose | Low Sucrose Diet Then High Sucrose |
---|---|---|
Arm/Group Description | High sucrose diet for 7 days, then low sucrose diet | Low sucrose diet for 7 days for first intervention, then high sucrose |
Period Title: First Intervention (7 Days) | ||
STARTED | 5 | 4 |
COMPLETED | 5 | 4 |
NOT COMPLETED | 0 | 0 |
Period Title: First Intervention (7 Days) | ||
STARTED | 5 | 4 |
COMPLETED | 5 | 4 |
NOT COMPLETED | 0 | 0 |
Period Title: First Intervention (7 Days) | ||
STARTED | 5 | 4 |
COMPLETED | 5 | 4 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | All Participants |
---|---|
Arm/Group Description | All participants, cross-over study |
Overall Participants | 9 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
9
100%
|
>=65 years |
0
0%
|
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
24
(5)
|
Sex: Female, Male (Count of Participants) | |
Female |
0
0%
|
Male |
9
100%
|
Race and Ethnicity Not Collected (Count of Participants) | |
Region of Enrollment (participants) [Number] | |
United Kingdom |
9
100%
|
Outcome Measures
Title | Percentage Change in Liver Fat |
---|---|
Description | Liver fat was assessed by magnetic resonance spectrometry (MRS) |
Time Frame | 7 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | High Sucrose Diet | Low Sucrose Diet |
---|---|---|
Arm/Group Description | High sucrose diet for 7 days | Low sucrose diet for 7 days |
Measure Participants | 9 | 9 |
Mean (Standard Deviation) [percentage of change] |
1.9
(1.7)
|
1.9
(1.9)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | High Sucrose Diet |
---|---|---|
Comments | Baseline vs. treatment period | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.390 |
Comments | ||
Method | t-test, 2 sided | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Low Sucrose Diet |
---|---|---|
Comments | Baseline vs treatment | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.204 |
Comments | ||
Method | t-test, 2 sided | |
Comments |
Title | Changes in Fasting Triglyceride Levels |
---|---|
Description | Triglyceride levels assessed from plasma in fasting state |
Time Frame | Baseline and 7 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | High Sucrose Diet | Low Sucrose Diet |
---|---|---|
Arm/Group Description | High sucrose diet for 7 days | Low sucrose diet for 7 days |
Measure Participants | 9 | 9 |
Baseline |
0.9
(0.1)
|
0.9
(0.4)
|
7 days |
0.8
(0.3)
|
0.7
(0.3)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Low Sucrose Diet |
---|---|---|
Comments | Baseline vs treatment | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.001 |
Comments | calculated | |
Method | t-test, 2 sided | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | High Sucrose Diet |
---|---|---|
Comments | Baseline vs treatment | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.244 |
Comments | ||
Method | t-test, 2 sided | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | High Sucrose Diet, Low Sucrose Diet |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.244 |
Comments | ||
Method | ANOVA | |
Comments |
Adverse Events
Time Frame | 6 weeks | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | High Sucrose Diet | Low Sucrose Diet | ||
Arm/Group Description | High sucrose diet for 7 days | Low sucrose diet for 7 days | ||
All Cause Mortality |
||||
High Sucrose Diet | Low Sucrose Diet | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/9 (0%) | 0/9 (0%) | ||
Serious Adverse Events |
||||
High Sucrose Diet | Low Sucrose Diet | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/9 (0%) | 0/9 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
High Sucrose Diet | Low Sucrose Diet | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/9 (0%) | 0/9 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Prof Gary Frost |
---|---|
Organization | Imperial College London |
Phone | 020 7594 0959 |
g.frost@imperial.ac.uk |
- SucroseLiver