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

Primary Purpose

Hepatic Fatty Acid Metabolism, Systemic Insulin Resistance, Oxidative Stress

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
high sugar diet
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hepatic Fatty Acid Metabolism focused on measuring fructose, fatty liver disease, diet

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • School of Biomedical Sciences, University of Nottingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

fructose

glucose

Arm Description

25% dietary energy from fructose

25% dietary energy from glucose

Outcomes

Primary Outcome Measures

Liver triglyceride content

Secondary Outcome Measures

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

Full Information

First Posted
January 14, 2010
Last Updated
July 3, 2012
Sponsor
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT01050140
Brief Title
The Metabolic Effects of a High Fructose Versus a High Glucose Diet in Overweight Men
Official Title
The Metabolic Effects of a High Fructose Versus a High Glucose Diet in Overweight Men
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Fatty Acid Metabolism, Systemic Insulin Resistance, Oxidative Stress, Cardiovascular Status
Keywords
fructose, fatty liver disease, diet

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fructose
Arm Type
Experimental
Arm Description
25% dietary energy from fructose
Arm Title
glucose
Arm Type
Active Comparator
Arm Description
25% dietary energy from glucose
Intervention Type
Dietary Supplement
Intervention Name(s)
high sugar diet
Intervention Description
25% of dietary energy from fructose or glucose
Primary Outcome Measure Information:
Title
Liver triglyceride content
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Muscle triglyceride content
Time Frame
2 weeks
Title
Total abdominal visceral fat content (MRI)
Time Frame
2 weeks
Title
Liver ATP, PME concentration and pH (31P MRS)
Time Frame
2 weeks
Title
Liver de novo lipogenesis
Time Frame
2 weeks
Title
Resting energy expenditure, lipid and carbohydrate oxidation rates
Time Frame
2 weeks
Title
Hepatic and systemic insulin resistance
Time Frame
2 weeks
Title
Cardiovascular measures using finometry
Time Frame
2 weeks
Title
Systemic oxidative stress and inflammatory cytokine profile
Time Frame
2 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian A Macdonald, PhD
Organizational Affiliation
School of Biomedical Sciences, Nottingham University, UK
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Richard D Johnston, MRCP
Organizational Affiliation
School of Biomedical Sciences, Nottingham University, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Biomedical Sciences, University of Nottingham
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23872500
Citation
Johnston RD, Stephenson MC, Crossland H, Cordon SM, Palcidi E, Cox EF, Taylor MA, Aithal GP, Macdonald IA. No difference between high-fructose and high-glucose diets on liver triacylglycerol or biochemistry in healthy overweight men. Gastroenterology. 2013 Nov;145(5):1016-1025.e2. doi: 10.1053/j.gastro.2013.07.012. Epub 2013 Jul 19.
Results Reference
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The Metabolic Effects of a High Fructose Versus a High Glucose Diet in Overweight Men

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