The Metabolic Effects of a High Fructose Versus a High Glucose Diet in Overweight Men

Study Overview
=================
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: The ultimate fate of this increased hepatic fatty acid production following a high fructose vs. glucose diet The effect of a high fructose vs. glucose diet on liver ATP stores The effect of a high fructose vs. glucose diet on markers of oxidative stress 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.

Official Title
-----------------
The Metabolic Effects of a High Fructose Versus a High Glucose Diet in Overweight Men

Conditions
-----------------
Hepatic Fatty Acid Metabolism, Systemic Insulin Resistance, Oxidative Stress, Cardiovascular Status

Intervention / Treatment
-----------------
* Dietary Supplement: high sugar diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index 25-32 Waist > hip circumference Age 18-50 years Male Exclusion Criteria: Reported weight change > 3 kg in prior 3/12 Active health problems Contraindications to MRI scanning Symptoms of functional bloating or irritable bowel syndrome Abnormal liver or renal function tests Random glucose greater than 11.0 mmol/L Evidence of metabolic or viral liver disease as screened for by hepatitis B and C serology, and ferritin. Alcohol intake > 21 units per week Vegetarianism Normal daily fructose intake from drinks greater than that in 500ml of coca cola 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fructose<br>25% dietary energy from fructose | Dietary Supplement: high sugar diet<br>* 25% of dietary energy from fructose or glucose<br>|
| Active Comparator: glucose<br>25% dietary energy from glucose | Dietary Supplement: high sugar diet<br>* 25% of dietary energy from fructose or glucose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver triglyceride content |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle triglyceride content |  | 2 weeks | 
| Total abdominal visceral fat content (MRI) |  | 2 weeks | 
| Liver ATP, PME concentration and pH (31P MRS) |  | 2 weeks | 
| Liver de novo lipogenesis |  | 2 weeks | 
| Resting energy expenditure, lipid and carbohydrate oxidation rates |  | 2 weeks | 
| Hepatic and systemic insulin resistance |  | 2 weeks | 
| Cardiovascular measures using finometry |  | 2 weeks | 
| Systemic oxidative stress and inflammatory cytokine profile |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fructose, fatty liver disease, diet