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

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01050140
• Other study ID #: D/10/2009
• Status: Completed
• Phase: N/A
• First received: January 14, 2010
• Last updated: July 3, 2012
• Start date: January 2010
• Est. completion date: April 2011

Study information

• Verified date: July 2012
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Status
• Hepatic Fatty Acid Metabolism
• Insulin Resistance
• Oxidative Stress
• Systemic Insulin Resistance

Intervention

Dietary Supplement:
• high sugar diet
25% of dietary energy from fructose or glucose

Locations

Country	Name	City	State
United Kingdom	School of Biomedical Sciences, University of Nottingham	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver triglyceride content		2 weeks	No
Secondary	Muscle triglyceride content		2 weeks	No
Secondary	Total abdominal visceral fat content (MRI)		2 weeks	No
Secondary	Liver ATP, PME concentration and pH (31P MRS)		2 weeks	No
Secondary	Liver de novo lipogenesis		2 weeks	No
Secondary	Resting energy expenditure, lipid and carbohydrate oxidation rates		2 weeks	No
Secondary	Hepatic and systemic insulin resistance		2 weeks	No
Secondary	Cardiovascular measures using finometry		2 weeks	No
Secondary	Systemic oxidative stress and inflammatory cytokine profile		2 weeks	No