Clinical trial NCT01050140: The Metabolic Effects of a High Fructose Versus a High Glucose Diet in Overweight Men
Official title: The Metabolic Effects of a High Fructose Versus a High Glucose Diet in Overweight Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Fatty Acid Metabolism
Systemic Insulin Resistance
Oxidative Stress
Cardiovascular Status
Keywords: fructose
fatty liver disease
diet
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2010-01-15
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Dietary consumption of fructose has increased by nearly 50% since 1960.

A high fructose diet (HFrD) results in greater visceral adiposity and systemic insulin resistance than a high glucose diet. The effects of fructose on liver fatty acid and ATP stores, systemic oxidative stress and cardiovascular status are not fully known.

Detailed description: The protocol will assess the following outcomes:

1. The ultimate fate of this increased hepatic fatty acid production following a high fructose vs. glucose diet
2. The effect of a high fructose vs. glucose diet on liver ATP stores
3. The effect of a high fructose vs. glucose diet on markers of oxidative stress
4. The effect of a high fructose vs. glucose diet on cardiovascular status

Factors critical to carbohydrate metabolism such as systemic insulin resistance, body composition, energy expenditure, physical activity will also be assessed.

32 centrally overweight healthy males with a low baseline fructose intake will be recruited. They will be randomised double blindly to receive 25% of their dietary energy requirements from either fructose or glucose for 14 days.

The sugars will first be taken in an energy balanced and then an overfeeding setting.

Eligibility criteria: Inclusion Criteria:

1. Body mass index 25-32
2. Waist \> hip circumference
3. Age 18-50 years
4. Male

Exclusion Criteria:

1. Reported weight change \> 3 kg in prior 3/12
2. Active health problems
3. Contraindications to MRI scanning
4. Symptoms of functional bloating or irritable bowel syndrome
5. Abnormal liver or renal function tests
6. Random glucose greater than 11.0 mmol/L
7. Evidence of metabolic or viral liver disease as screened for by hepatitis B and C serology, and ferritin.
8. Alcohol intake \> 21 units per week
9. Vegetarianism
10. Normal daily fructose intake from drinks greater than that in 500ml of coca cola
11. Abnormal carbohydrate energy contribution to baseline diet - defined as greater than 2 standard deviations from the mean of the National Diet and Nutrition Survey 2002 data

Primary outcomes:
measure: Liver triglyceride content
timeFrame: 2 weeks
Secondary outcomes:
measure: Muscle triglyceride content
timeFrame: 2 weeks
measure: Total abdominal visceral fat content (MRI)
timeFrame: 2 weeks
measure: Liver ATP, PME concentration and pH (31P MRS)
timeFrame: 2 weeks
measure: Liver de novo lipogenesis
timeFrame: 2 weeks
measure: Resting energy expenditure, lipid and carbohydrate oxidation rates
timeFrame: 2 weeks
measure: Hepatic and systemic insulin resistance
timeFrame: 2 weeks
measure: Cardiovascular measures using finometry
timeFrame: 2 weeks
measure: Systemic oxidative stress and inflammatory cytokine profile
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: School of Biomedical Sciences, University of Nottingham
state: Nottinghamshire
Study officials:
affiliation: School of Biomedical Sciences, Nottingham University, UK
name: Ian A Macdonald, PhD
role: STUDY_CHAIR
affiliation: School of Biomedical Sciences, Nottingham University, UK
name: Richard D Johnston, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnston RD, Stephenson MC, Crossland H, Cordon SM, Palcidi E, Cox EF, Taylor MA, Aithal GP, Macdonald IA. No difference between high-fructose and high-glucose diets on liver triacylglycerol or biochemistry in healthy overweight men. Gastroenterology. 2013 Nov;145(5):1016-1025.e2. doi: 10.1053/j.gastro.2013.07.012. Epub 2013 Jul 19.