Healthy Volunteers Clinical Trial
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%
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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