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Effects of Dietary Fructose on Glucose and Lipid Metabolism in Healthy Human Subjects

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. Identifier: NCT01021969
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : July 19, 2011
Swiss National Science Foundation
Information provided by:
University of Zurich

Brief Summary:

The increasing intake of fructose has been associated with an increase in obesity among US children and adolescents, but its "dose dependent" effects on insulin sensitivity and lipid metabolism has not been studied in detail. Methods: 36 healthy male adult human subjects will be included in this study. They will be randomly allocated into a low, moderate or high fructose, a moderate or high glucose and a sucrose diet for 3 weeks. In randomized order and with 4 week wash out intervals each subject will receive all six different diets. Three day food records will be used to measure total fructose and glucose intake. During the low fructose diet subjects will be instructed to avoid nutrients containing fructose aiming at consumption of less than 1g fructose/d. During the moderate fructose diet subjects will receive 3x13.3g of fructose or glucose, respectively. High fructose diet subjects will receive either 3x26.7g/d of fructose, 3x 26.7g/d of glucose or 3x 26.7g/d of sucrose in the form of three daily soft drinks taken together with the three main meals.

75 g oral glucose tolerance testing will be performed and composite insulin sensitivity index will be calculated The presence of phosphorylated fructose metabolites in plasma will be measured by targeted LC-MS/MS. In addition, metabolite biomarkers in plasma will be screened by untargeted metabolite profiling using both LC-MS and GC-MS. In a subgroup of 10 subjects an euglycemic hyperinsulinemic clamp will be performed using [6,6- 2H2]glucose.

Thus, the lipogenic potential of fructose in humans will be compared with isocaloric amounts of glucose. Particularly, the question whether lipogenic effects are continuously dose dependent or whether there is a lipogenic shunting and if yes, at what level of ingested fructose will be addressed.

Condition or disease Intervention/treatment Phase
Healthy Other: Fructose Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effects of Dietary Fructose on Glucose and Lipid Metabolism in Healthy Human Subjects
Study Start Date : June 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Fructose

Intervention Details:
  • Other: Fructose
    Subjects consume different amounts of fructose, glucose and sucrose in a crossover design

Primary Outcome Measures :
  1. LDL size [ Time Frame: baseline and after each of 6 interventions ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Healthy male volunteers aged 20-50y with a BMI between 19 and 25 kg/m2

Exclusion criteria:

  • Acute infection, malignant disease, renal (abnormal creatinine), hepatic (more than two-fold increased transaminases), pulmonary, neurological (epilepsy) or major psychiatric diseases, manifested atherosclerosis
  • Fasting plasma glucose > 5.6 mmol/l
  • Known alcohol or drug abuse
  • HIV-antibody positive
  • Subjects likely to fail to comply with the study protocol
  • Smoking (>1 cigarette/month)
  • Subjects who do not give informed consent

Additional exclusion criteria after baseline measurements:

  • Subjects with high baseline consumption of soft drinks (>60g of carbohydrates daily)

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 identifier (NCT number): NCT01021969

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University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Swiss National Science Foundation
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Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: PD Dr. med Kaspar Berneis, University of Zurich Identifier: NCT01021969    
Other Study ID Numbers: 32003B-119706
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: July 19, 2011
Last Verified: July 2011