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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01050140
Recruitment Status : Completed
First Posted : January 15, 2010
Last Update Posted : July 4, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Hepatic Fatty Acid Metabolism Systemic Insulin Resistance Oxidative Stress Cardiovascular Status Dietary Supplement: high sugar diet

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Metabolic Effects of a High Fructose Versus a High Glucose Diet in Overweight Men
Study Start Date : January 2010
Primary Completion Date : December 2010
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: fructose
25% dietary energy from fructose
Dietary Supplement: high sugar diet
25% of dietary energy from fructose or glucose
Active Comparator: glucose
25% dietary energy from glucose
Dietary Supplement: high sugar diet
25% of dietary energy from fructose or glucose


Outcome Measures

Primary Outcome Measures :
  1. Liver triglyceride content [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Muscle triglyceride content [ Time Frame: 2 weeks ]
  2. Total abdominal visceral fat content (MRI) [ Time Frame: 2 weeks ]
  3. Liver ATP, PME concentration and pH (31P MRS) [ Time Frame: 2 weeks ]
  4. Liver de novo lipogenesis [ Time Frame: 2 weeks ]
  5. Resting energy expenditure, lipid and carbohydrate oxidation rates [ Time Frame: 2 weeks ]
  6. Hepatic and systemic insulin resistance [ Time Frame: 2 weeks ]
  7. Cardiovascular measures using finometry [ Time Frame: 2 weeks ]
  8. Systemic oxidative stress and inflammatory cytokine profile [ Time Frame: 2 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050140


Locations
United Kingdom
School of Biomedical Sciences, University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01050140     History of Changes
Other Study ID Numbers: D/10/2009
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: July 4, 2012
Last Verified: July 2012

Keywords provided by University of Nottingham:
fructose
fatty liver disease
diet

Additional relevant MeSH terms:
Overweight
Insulin Resistance
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases