Recruitment

Recruitment Status
Completed
Estimated Enrollment
10

Exclusion Criterias

A history of drug or alcohol abuse in the last 2 years
Cardiovascular, hepatic or renal disease
Regular consumer of sugar sweetened beverages
...
A history of drug or alcohol abuse in the last 2 years
Cardiovascular, hepatic or renal disease
Regular consumer of sugar sweetened beverages
Any gastrointestinal disorder e.g. Crohn's disease, coeliac disease or irritable bowel syndrome
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
Pancreatitis
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 chronic illness
Unable to have MRI (eg. metallic or magnetic implants, claustrophobia)

Summary

Conditions
Healthy Volunteers
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Basic Science

Participation Requirements

Age
Between 20 years and 40 years
Gender
Only males

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...

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.

Exclusion Criterias

A history of drug or alcohol abuse in the last 2 years
Cardiovascular, hepatic or renal disease
Regular consumer of sugar sweetened beverages
...
A history of drug or alcohol abuse in the last 2 years
Cardiovascular, hepatic or renal disease
Regular consumer of sugar sweetened beverages
Any gastrointestinal disorder e.g. Crohn's disease, coeliac disease or irritable bowel syndrome
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
Pancreatitis
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 chronic illness
Unable to have MRI (eg. metallic or magnetic implants, claustrophobia)

Locations

London
London

Tracking Information

NCT #
NCT02015442
Collaborators
Not Provided
Investigators
  • Principal Investigator: Gary Frost Imperial College London
  • Gary Frost Imperial College London