Healthy Volunteers
Conditions
Keywords
Sucrose in diet
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%
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.
Interventions
DIETARY_SUPPLEMENTSucrose
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Liver Fat | 7 days | Liver fat was assessed by magnetic resonance spectrometry (MRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Fasting Triglyceride Levels | Baseline and 7 days | Triglyceride levels assessed from plasma in fasting state |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants, cross-over study | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 9 Participants | — |
| Age, Continuous | 24 years STANDARD_DEVIATION 5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 9 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
Percentage Change in Liver Fat
Liver fat was assessed by magnetic resonance spectrometry (MRS)
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Sucrose Diet | Percentage Change in Liver Fat | 1.9 percentage of change | Standard Deviation 1.7 |
| Low Sucrose Diet | Percentage Change in Liver Fat | 1.9 percentage of change | Standard Deviation 1.9 |
Comparison: Baseline vs. treatment periodp-value: 0.39t-test, 2 sided
Comparison: Baseline vs treatmentp-value: 0.204t-test, 2 sided
Secondary
Changes in Fasting Triglyceride Levels
Triglyceride levels assessed from plasma in fasting state
Time frame: Baseline and 7 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Sucrose Diet | Changes in Fasting Triglyceride Levels | Baseline | 0.9 mmol/l | Standard Deviation 0.1 |
| High Sucrose Diet | Changes in Fasting Triglyceride Levels | 7 days | 0.8 mmol/l | Standard Deviation 0.3 |
| Low Sucrose Diet | Changes in Fasting Triglyceride Levels | Baseline | 0.9 mmol/l | Standard Deviation 0.4 |
| Low Sucrose Diet | Changes in Fasting Triglyceride Levels | 7 days | 0.7 mmol/l | Standard Deviation 0.3 |
Comparison: Baseline vs treatmentp-value: 0.001t-test, 2 sided
Comparison: Baseline vs treatmentp-value: 0.244t-test, 2 sided
p-value: 0.244ANOVA