- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01050140
The Metabolic Effects of a High Fructose Versus a High Glucose Diet in Overweight Men
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nottinghamshire
-
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
- School of Biomedical Sciences, University of Nottingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: fructose
25% dietary energy from fructose
|
25% of dietary energy from fructose or glucose
|
Active Comparator: glucose
25% dietary energy from glucose
|
25% of dietary energy from fructose or glucose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Liver triglyceride content
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Muscle triglyceride content
Time Frame: 2 weeks
|
2 weeks
|
Total abdominal visceral fat content (MRI)
Time Frame: 2 weeks
|
2 weeks
|
Liver ATP, PME concentration and pH (31P MRS)
Time Frame: 2 weeks
|
2 weeks
|
Liver de novo lipogenesis
Time Frame: 2 weeks
|
2 weeks
|
Resting energy expenditure, lipid and carbohydrate oxidation rates
Time Frame: 2 weeks
|
2 weeks
|
Hepatic and systemic insulin resistance
Time Frame: 2 weeks
|
2 weeks
|
Cardiovascular measures using finometry
Time Frame: 2 weeks
|
2 weeks
|
Systemic oxidative stress and inflammatory cytokine profile
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ian A Macdonald, PhD, School of Biomedical Sciences, Nottingham University, UK
- Principal Investigator: Richard D Johnston, MRCP, School of Biomedical Sciences, Nottingham University, UK
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D/10/2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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