Ignite Creation Date:
2024-05-05 @ 10:05 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01021969
Status:
COMPLETED
Last Update Posted:
2011-07-19
First Post:
2009-11-25
Brief Title:
Effects of Dietary Fructose on Glucose and Lipid Metabolism in Healthy Human Subjects
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Effects of Dietary Fructose on Glucose and Lipid Metabolism in Healthy Human Subjects
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 fructosed During the moderate fructose diet subjects will receive 3x133g of fructose or glucose respectively High fructose diet subjects will receive either 3x267gd of fructose 3x 267gd of glucose or 3x 267gd 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-MSMS 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 66- 2H2glucose
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
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-MSMS 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 66- 2H2glucose
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None