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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01050140
First received: January 14, 2010
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Hepatic Fatty Acid Metabolism
Systemic Insulin Resistance
Oxidative Stress
Cardiovascular Status
 Dietary Supplement: high sugar diet

Study Type: Interventional
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
Official Title: The Metabolic Effects of a High Fructose Versus a High Glucose Diet in Overweight Men

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Liver triglyceride content [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscle triglyceride content [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Total abdominal visceral fat content (MRI) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Liver ATP, PME concentration and pH (31P MRS) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Liver de novo lipogenesis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Resting energy expenditure, lipid and carbohydrate oxidation rates [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Hepatic and systemic insulin resistance [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Cardiovascular measures using finometry [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Systemic oxidative stress and inflammatory cytokine profile [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: January 2010
Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01050140     History of Changes
Other Study ID Numbers: D/10/2009
Study First Received: January 14, 2010
Last Updated: July 3, 2012
Health Authority: United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 21, 2013